Industry News Briefs from the International Neuromodulation Society

Industry News Feed

Company Licenses Noninvasive Vagus Nerve Stimulation Technology

March 12, 2019 - Cala Health, Inc. has licensed noninvasive technology developed from research on transcutaneous vagus nerve stimulation and respiratory-gated vagal afferent nerve stimulation, for its portfolio of wearable therapies for chronic disease. The Massachusetts General Hospital developers of the technology will serve as scientific advisors to the company. (AP News)

Company Submits Sacral Neuromodulation Data for Its Premarket Approval Application

Feb. 26, 2019 - Axonics Modulation Technologies announced that, as an amendment to its premarket approval application, it has submitted clinical data to the FDA about its sacral neuromodulation system for the treatment of urinary and bowel dysfunction. (Business Wire)

Company Announces Insurance Coverage Decision for Vagus Nerve Stimulator to Treat Episodic Headache

Feb. 26, 2019 - The device company electroCore, Inc. announced an insurance coverage decision from Highmark for the company's noninvasive vagus nerve stimulator for abortive treatment of episodic migraine and episodic cluster headaches. The insurer serves more than 5 million patients in Pennsylvania, Delaware, and West Virginia. (Globe Newswire)

Draft Guidance Issued on Development of Brain-Computer Interfaces

Feb. 25, 2019 - The U.S. FDA has issued draft guidance that outlines recommendations for non-clinical testing and clinical study design related to development of brain-computer-interface (BCI) devices for paralyzed patients or amputees. These brain implants are intended to help provide some mobility or sense of touch. The draft guidance will be open for public comment. (Verdict Medical Devices)

Clinical Trial to Begin for Noninvasive Device to Potentially Treat Overactive Bladder

Feb. 25, 2019 - FemPulse Corporation announced plans for a safety-and-performance clinical trial of its non-implanted vaginal ring intended to deliver neurostimulation to help relieve symptoms of overactive bladder. (AP)

Data Presented at Meeting Concerning Noninvasive Device Investigated for Epileptic Seizures

Feb. 25, 2019 - Neuroelectrics Corporation presented results of its clinical trial of a noninvasive brain stimulation device intended to reduce the frequency of seizures in epilepsy. (Business Wire)

Device Company Founder Describes Path of Technology and Commercial Development

Fall 2018 - In an alumni magazine profile, a device-company founder describes her interest in closed-loop control systems -- initially from a motivation to help regulate insulin levels. The decision was made to start with pain control as the fastest and easiest "roadmap" to get the device on the market. Later, she envisions research into "modalities like thyroid control". (Lift)

Company Says CMS Has Modified a Coverage Decision about Vagus Nerve Stimulation

Feb. 21, 2019 - LivaNova announced the U.S. Centers for Medicare & Medicaid Services (CMS) issued a modified national coverage decision, through a CMS Coverage with Evidence Development framework, which will enable Medicare coverage for its vagus nerve stimulation for treatment-resistant depression when offered through a CMS-approved, double-blind, randomized, placebo-controlled trial with a follow-up of at least one year. (Mass Device)

Company Announces U.S. Launch of Deep Brain Stimulation in Medically Refractory Epilepsy

Feb. 20, 2019 - Medtronic announced the U.S. launch of deep brain stimulation therapy for medically refractory epilepsy. (Globe Newswire)

Company Focused on Technology for Powering Neuromodulation Implants Completes $26 Million Series B Financing

Feb. 20, 2019 - Start-up Neuspera, which is pursuing development of power technology for neuromodulation implants, has closed a $12 million final round of its $26 million Series B equity financing. (Cision)

Company Files Pivotal Study Data with FDA

Feb. 20, 2019 - Axonics has filed interim clinical data with the FDA from its pivotal study of its sacral neuromodulation system for the treatment of urinary and bowel dysfunction. (NeuroNews)

Grant Will Fund Feasibility Study of Noninvasive Brain Stimulation in Addiction

Feb. 13, 2019 - Soterix Medical Inc. announced it has been awarded a Small Business Research Innovation Research grant of $475,000 from the National Institute of Drug Abuse of the National Institutes of Health, for a feasibility study of its self-administered system for transcranial direct current stimulation to potentially reduce craving for cocaine. (Cision)

Company Announces a New Category / CPT Code for Its Responsive Neurostimulation System

Feb. 13, 2019 - NeuroPace announced that the American Medical Association has issued a new reimbursement code for review and interpretation of brain-activity data from its neurostimulation system that monitors and responds to focal epileptic seizures. The code went into effect Jan. 1, 2019. (NeuroNews)

Company Seeks Full-Body Conditional FDA Labeling for Its Sacral Neuromodulation System

Feb. 12, 2019 - Axonics has submitted data to the FDA to seek full-body conditional MRI labeling for its sacral neuromodulation system. (Seeking Alpha)

FDA Clearance Announced for Noninvasive Stimulation for Migraine Pain

Feb. 6, 2019 - The company electroCore LLC announced it has received an expanded FDA clearance for use of its noninvasive vagus nerve stimulator as an acute treatment for migraine pain in adults. (Pain Medicine News)

Company Announces Software Approval for Drug Delivery Device

Feb. 6, 2019 - Flowonix Medical announced FDA approval of clinician programmer software for its Prometra intrathecal infusion system. (Drug Delivery Business News)

Visual Prosthesis Undergoes Clinical Trial

Feb. 6, 2019 - An article describes a visual prosthesis undergoing clinical study in Australia in seven patients who have retinitis pigmentosum. (ZD Net)

Agency Reconsiders Coverage of Vagus Nerve Stimulation for Depression

Feb. 5, 2019 - An article anticipates an agency decision about Medicare and Medicaid coverage of implanted vagus nerve stimulators for patients with treatment-resistant depression. (MedTech Dive)

Company Raises $8 Million in Series C Funding

Jan. 31, 2019 - According to an SEC filing, SPR Therapeutics has raised $8 million of a $20 million Series C round of funding that began in January. (Mass Device)

Device Company Launches Spinal Cord Stimulation System in Europe

Jan. 31, 2019 - Boston Scientific Corporation has launched the Spectra WaveWriter spinal cord stimulation system in Europe. (NeuroNews)

FDA Requires Additional Time to Review a Pre-Market Approval Application

Jan. 30, 2019 - Nuvectra announced the FDA will extend its review period for the pre-market approval of the company's sacral neuromodulation system, past the 180-day deadline. (BioPortfolio)

Company Receives CE Mark for MRI-Conditional Labeling of Neurostimulation System

Jan. 29, 2019 - Abbott has received CE mark approval for MRI-conditional labeling of its Infinity deep brain stimulation system. (NeuroNews International)

Study Evaluates Overactive Bladder Patients' Medication Use after Sacral Neuromodulation

Jan. 25, 2019 - A study found that more than 80% of overactive bladder patients who progressed to sacral neuromodulation discontinued their medications for the condition. (Journal of Urology)

New Guidance Issued by NICE Concerning a Form of Spinal Cord Stimulation

Jan. 23, 2019 - The U.K. National Institute for Health and Care Excellence, NICE, has introduced new guidance on a form of spinal cord stimulation as a treatment option for chronic neuropathic back or leg pain after failed back surgery. (NICE)

Rechargeable, Directional Deep Brain Stimulation System Launched

Jan. 25, 2019 - Boston Scientific announced launch of the rechargeable Vercise Gevia deep brain stimulation system and Vercise primary cell for the treatment of symptoms of Parkinson's disease. (NeuroNews)

Data Reported on High-Frequency Peripheral or Spinal Cord Stimulation in Pain Patients

Jan. 24, 2019 - Clinicians at an Australian facility gathered data on pain scores for 12 months in patients implanted with high-frequency spinal cord stimulators or peripheral nerve stimulators. (NeuroNews)

Neuromodulation Presented as a Health Technology that May Aid the Opioid Crisis

Jan. 23, 2019 - A healthcare technology business story presents neuromodulation as being considered a partial solution for the opioid crisis. The article says specialists believe it should be offered earlier in the treatment process. It adds that research is taking place to determine which patients benefit most from newer neurostimulation modes and devices. (STAT)

Studies Examine Burst Stimulation Mode in Pain Patients

Jan. 22, 2019 - Abbott released results from the BOLD study of intermittent burst stimulation, and discussed a second study of spinal cord stimulation patients. (Mass Device)

Foundation Issues Grant for Pre-surgical Customization of Neurostimulation for Epilepsy

Jan. 22, 2019 - The Epilepsy Foundation awarded a $150,000 grant to Greg Worrell, MD, PhD, professor of neurology and chair of clinical neurophysiology at Mayo Clinic, for development of a protocol during surgical evaluation to test electrical stimulation parameters to optimize and personalize therapy to enhance seizure control. (Cision)

Neurostimulation Company Releases Six-Month Study Data

Jan. 17, 2019 - Stimwave released six-month data from a trial of its spinal cord stimulation system in patients with back and leg pain, in which high or low frequency stimulation was used. (Mass Device)

First Patient Enrolled in Study of Intrathecal Drug Delivery in Pain Patients Who Were Weaned Off of Oral Opioids

Jan. 17, 2019 - Medtronic announced enrollment of the first patient in a study of the use of its intrathecal drug delivery device in people with chronic intractable non-malignant primary back pain who have been weaned off of oral opioids. (Drug Delivery Business News)

Annual Research Prize for Junior Investigators Announced

Jan. 16, 2019 - There is a March 15, 2019 deadline for junior investigators aged 45 or younger, who have received an advanced degree in the past 10 years, to submit an entry for the Science and PINS Prize in Neuromodulation. The $25,000 prize is based on an essay about research performed in the past three years. The award was started in 2016 by Science magazine and PINS Medical of China. In addition to the cash award, winners have their essay published in Science magazine. (Science 2.0)

Israeli Company Prepares for US. Stock Exchange Offering

Jan. 15, 2019 - Brainsway Ltd. has filed a prospectus for a public offering on Nasdaq to raise at least $30 million. Timing of the offering depends upon when approval of the prospectus is received from the U.S. Securities and Exchange Commission, which was affected by the U.S. government shutdown. (Globes)

Industry Observers Discuss the Role of Neuromodulation in Pain Treatment

Jan. 15, 2019 - A news feature about neuromodulation and pain presents viewpoints about a larger context for the treatment, with one physician saying neuromodulation can be part of the answer to part of the opioid problem, and that with individual patients, expectation management is important. (Mass Device)

Company Plans Patient Registry

Jan. 14, 2019 - Bioness, Inc. announced that for its peripheral nerve stimulator, it has launched a patient registry, to which patients will be able to opt-in to join. (Cision)

Headache Symposium Includes Preliminary Results from a Clinical Trial of a Wearable Device to Treat Migraine

Jan. 9, 2019 - Remarks at the 4th Annual International Headache Symposium in Israel included preliminary results of a randomized, double-blind, parallel group, sham-controlled clinical trial of a migraine treatment device that stimulates the occipital and trigeminal nerves. (Business Wire)

Company Reports New Clinical Trials in Noninvasive Vagus Nerve Stimulation for Migraine

Jan. 8, 2019 - ElectroCore, Inc. announced two clinical studies focused on expanding the use of non-invasive vagus nerve stimulation for acute and preventive treatment of migraine. The company also noted publication of a retrospective analysis of the treatment in a clinical trial in cluster headache patients. (Globe Newswire)

Visual Prosthetic Meets Six-Month Endpoints in Feasibility Study

Jan. 8, 2019 - Pixium Vision reported interim six-month follow-up results of a feasibility study of its visual prosthetic implant, a wireless sub-retinal photovoltaic microchip, in patients with advanced dry age-related macular degeneration. (Pharmalive)

FDA Clears Sinus Pain Device

Jan. 3, 2019 - TIVIC Health systems Inc. announced 510(k) clearance from the FDA for its transcutaneous, hand-held neurostimulation device to treat sinus pain due to allergic rhinitis. (PR Newswire)

New Device Company Launches

Jan. 3, 2019 - Dr. V. Reggie Edgerton announced formation of SpineX, a Los Angeles-based medical device company developing non-invasive devices to stimulate the spinal cord. (Globe Newswire)

Neurostimulation Company Divests Subsidiary Focused on Neuroscience Clinical Animal Research Technology

Jan. 2, 2019 - Nuvectra Corporation announced it has agreed to sell its subsidiary NeuroNexus Technologies, Inc. to NEL Group, Inc., for $5 million in cash. (Globe Newswire)

Company Announces a European Full-Body Conditional MRI Approval for Its Device

Dec. 18, 2018 - Nuvectra Corporation announced it has received European conditional approval for its Algovita spinal cord stimulator for full-body MRI scans. (Medgadget)

Company Announces FDA Approval of Device Programmer

Dec. 17, 2018 - Medtronic announced it has received FDA approval for a mobile, handheld, app-based programmer for use with its sacral neuromodulation system. (Pilot Online)

Company Announces an FDA Head-Only MRI-Conditional Approval

Dec. 12, 2018 - Nuvectra announced it received FDA head-only conditional approval for its spinal cord stimulation system. (Neuro News)

Company Seeks CE Mark for Device to Treat Balance Deficit

Dec. 12, 2018 - A noninvasive device for the treatment of chronic balance deficit due to mild to moderate traumatic brain injury is subject to a CE mark application. The application was made by a subsidiary of the device company Helius Medical Technologies, Inc. (Globe Newswire)

Joint Venture Centers on Deep Brain Stimulation Surgery Navigation

Dec. 11, 2018 - An Israeli startup that designs targeting tools for deep brain stimulation has received a $7 million investment from the Guangzhou Sino-Israel Biotech Investment Fund, which is setting up a joint venture of the company and fund in China. (Globes)

Canada Clinic Adds Neuroplasticity Stimulator

Dec. 6, 2018 - A neurorehabilitation clinic in Montreal is the first to use a noninvasive stimulator, recently approved by Health Canada, to stimulate neuroplasticity during intensive physiotherapy sessions. The stimulator sits on the tongue, which sends information to the brain through cranial nerves. (CTV News Montreal)

Israeli Company Develops a Neurostimulator to Potentially Treat Migraine Pain

Dec. 5, 2018 - An article describes a noninvasive stimulator being developed by an Israeli company for the treatment of migraine. The head-worn device has six electrodes to stimulate different nerve branches. The article mentions a clinical trial, and regulatory approval plans, as well as future interest in a potential related device to address depression. (Israel21c)

Device Maker Registers Offering of Common Stock

Dec. 4, 2018 - Inspire Medical Systems, which makes a neurostimulation device for treating obstructive sleep apnea, is offering 1.5 million shares of common stock and hopes to make $66.8 million on the sale. In addition, stockholders are selling an additional 1 million shares of stock. The company had an initial public offering in April. (Mass Device)

Device Company Files for FDA Approval

Dec. 4, 2018 - Axonics has filed a literature-based FDA pre-market approval application for its rechargeable sacral nerve stimulator treatment for urinary and bowel dysfunction. In parallel, the company is running a pivotal trial of 129 patients with urinary dysfunction. (Mass Device)

Long-term Results of Responsive Neurostimulation in Epilepsy Announced

Dec. 2, 2018 - NeuroPace announced results of a nine-year study, at 33 centers, of its responsive neurostimulation system in 256 patients with focal seizures that have not responded to medication. (Business Wire)

Neuromodulation is Among Innovation Challenge Winners for Potentially Helping to Address Opioid Crisis

Nov. 30, 2018 - A deep transcranial magnetic stimulation device was among eight proposals, out of more than 250 submissions, selected in an innovation challenge by the FDA Center for Devices and Radiological Health that sought approaches to combat opioid use disorder, for instance, through managing pain. (FDA Voices)

U.K. Health System Adds Sacral Neuromodulator to Supply Chain

Nov. 29, 2018 - Axonics announced its sacral nerve stimulator has been added to a centralized supply catalogue for U.K. National Health Service hospitals. (Business Wire)

Noninvasive Device Receives Clearance for Preventive Treatment in Cluster Headache

Nov. 28, 2018 - ElectroCore announced an expanded FDA approval for its handheld vagus nerve simulator, which is now cleared for adjunctive use in preventive treatment of cluster headache. (Mass Device)

U.S. Centers for Medicare & Medicaid Services Proposes a Clinical Trial of Vagus Nerve Stimulation for Treatment-Resistant Depression

Nov. 26, 2018 -  The U.S. Centers for Medicare & Medicaid Services has proposed obtaining more data as it looks to adjust its 2007 determination of non-coverage for vagus nerve simulation for treatment-resistant depression. The agency proposes a double-blinded, randomized, placebo-controlled trial with a one-year follow-up and the possibility of extension into a prospective longitudinal study. (Mass Device)

Initial Public Offering Raises an Additional $18 Million Through Exercise of an Over-allotment Option

Nov. 19, 2018 - Investors exercised an over-allotment option that added $18 million to the proceeds of the initial public offering for Axonics Modulation Technologies. Exercise of that option took gross proceeds to $138 million. (Mass Device)

Dorsal Root Ganglion Stimulation Trial System Receives FDA Clearance and CE Mark Approval

Nov. 15, 2018 - Abbott has won FDA clearance and CE Mark approval for its DRG Invisible Trial System, which chronic pain patients can control wirelessly during the trial phase, using a handheld device. (Mass Device)

Chronic Low Back Pain Patient Study Data Released

Nov. 19, 2018 - Data from up to one year has been released in an active sham-controlled trial of an implantable neurostimulator for chronic low back pain. (NeuroNews)

Complex Regional Pain Syndrome Patient Receives Peripheral Nerve Stimulation Device

Nov. 15, 2018 - A recently FDA-cleared single-lead peripheral nerve stimulation system has now been used in a case of complex regional pain syndrome. (NeuroNews)

Hypoglossal Nerve Stimulation Maker Raises Equity Financing

Nov. 12, 2018 - Nyxoah has raised about $17 million in equity financing for its rechargeable hypoglossal nerve stimulation device. An application for CE mark approval is planned. (Fierce Biotech)

U.S. Regulator's Initiative Aims to Hasten Alternatives to Opioids

Nov. 9, 2018 - The U.S. FDA reported robust interest in an initiative to speed alternatives to opioids, in an innovation challenge whose submissions include neuromodulation devices. (CNBC)

Outpatient Reimbursement Rate Set by CMS for Visual Prosthetic

Nov. 8, 2018 - The Centers for Medicare & Medicaid Services (CMS) set a 2019 outpatient-procedure reimbursement rate for Second Sight Medical's Argus II retinal prosthesis system of $152,500. (Mass Device)

Health Canada Approves Marketing of Patient Controller for Sacral Neuromodulation System

Nov. 7, 2019 - Health Canada has approved marketing of an external trial system for Axonics Modulation Technologies' rechargeable sacral neuromodulation system. (Business Wire)

A Reimbursement Coverage Decision Will Affect Phrenic Nerve Stimulation in an Outpatient Setting

Nov. 6, 2018 - The U.S. Centers for Medicare and Medicaid Services plans to extend a reimbursement, for phrenic nerve stimulation for central sleep apnea, into an outpatient setting, beginning in January 2019. (Sleep Review Magazine)

Non-invasive Neurostimulation Device Receives Marketing Approval in Canada

Oct. 29, 2018 - Health Canada has given marketing authorization for Helius Medical Technologies' portable neuromodulation stimulator as an adjunctive aspect of physical therapy for balance deficits following traumatic brain injury. The company also announced a partnership with the Feinstein Institute for Medical Research for investigational use of the device at three rehabiliation treatment sites in New York. (Market Watch)

Device Company Prices Its Initial Public Offering

Oct. 31, 2018 - Axonics Modulation Technologies Inc. priced its initial public offering at $15 a share, and sold 8 million shares to raise $120 million. The company is developing a rechargeable sacral neuromodulation system. (Market Watch)

Wireless Neurostimulator Company Announces FDA Approval for Its Patient-Controller Platform

Oct. 31, 2018 - Stimwave Technologies announced FDA approval of an iOS platform for patient control of its wireless spinal cord stimulation system from an iPhone or Apple watch. (Odessa American)

FDA Approval Announced for an Aspect of Intrathecal Drug Delivery

Oct. 25, 2018 - Medtronic announced FDA approval of an aspect of its SynchroMed II intrathecal drug delivery device, myPTM Personal Therapy Manager, which permits patients to deliver a bolus of pain medication, within therapeutic limits set by their physician. (NeuroNews)

Company Completes Enrollment for Pilot Study of Vagus Nerve Stimulation in Rheumatoid Arthritis

Oct. 16, 2018 - SetPoint Medical announced it has completed enrollment of 14 patients in a U.S. pilot study to evaluate the safety and tolerability of its vagus nerve stimulator for rheumatoid arthritis that has not improved through multiple different biologic therapies. (P&T Community)

Device Company Files Prospectus for a $86 Million Initial Public Offering

Oct. 7, 2018 - Axonics Modulation Technologies has filed a prospectus for an $86 million initial public offering. The company has developed a rechargeable sacral neuromodulation device. (Seeking Alpha)

U.S. Department of Defense Helps Fund Development of Percutaneous Pain Relief Implant

Oct. 3, 2018 - SPR Therapeutics announced it has received $10 million in a contract and two clinical trial grants from the U.S. Department of Defense. The support will fund development of its percutaneous peripheral nerve stimulation therapy for acute and chronic pain relief. (Mass Device)

Company Announces Minimally Invasive Implant of "Electroceutical" Device

Sept. 18, 2018 - MedAutonomic announced the first implant of its neurostimulation device in the stomach wall of a human patient. The device is implanted with a gastric endoscope and is designed to be powered by piezoelectric energy harvested by the "tail" of the device. The device is intended to balance autonomic nervous system function to treat conditions such as type-2 diabetes, hypertension, and gastroesophageal reflux disease. (Mass Device)

Company's Spinal Cord Stimulation System Approved in Australia

Sept. 19, 2018 - Nevro Corp.'s Senza II spinal cord stimulation system has received approval in Australia from the Therapeutic Goods Administration. (Neuro News)

Company Begins Clinical Trial of Vagus Nerve Stimulation in Heart Failure

Sept. 18, 2018 - LivaNova announced it has launched a pivotal study of its vagus nerve stimulation device for heart failure, with the first implant completed in Iowa. The multi-center Anthem-HFrEF study will have up to 800 participants through the year 2022. They will be randomized 2:1 to receive the implant or standard medical care. (Mass Device)

Neurostimulation Company Plans Follow-on Public Offering

Sept. 11, 2018 - Neurostimulation company Nuvectra Corporation announced a follow-on public offering of 2.825 million shares of common stock was priced by its underwriter at $21.25 per share, in an offering expected to close on or about Sept. 14, 2018. (Seeking Alpha)

U.K. Private Clinic to Offer New Neurostimulator for Chronic Disabling Low Back Pain

Sept. 9, 2018 - An article announces that a day surgery clinic is the first in England to offer a new type neurostimulator for chronic lower back pain. The device underwent successful trials through the National Health Service, and is available to private-pay patients. (Chelmsford & Mid Essex Times)

Insurer to Cover Dorsal Root Ganglion Stimulation

Sept. 4, 2018 - Health insurer Aetna has decided to provide national reimbursement coverage for the Proclaim dorsal root ganglion stimulator for neuropathic pain, opening up the therapy to about 22 million health plan members in the U.S.. An article notes that the FDA-approved device is also covered by Medicare, and other major health insurers are evaluating their coverage decisions. (Star Tribune)

Company Requests FDA Clearance for Non-invasive Device to Address Balance Issues Due to Traumatic Brain Injury

Sept. 4, 2018 - Helius Medical Technologies, Inc. is requesting an FDA de novo classification and 510(k) clearance of its Portable Neuromodulation Stimulator (PoNS™) device for the treatment of chronic balance deficit due to mild- to moderate-traumatic brain injury. (P&T Community)

Company Pursues Development of Small, Wireless, Networked Neurostimulators

Aug. 30, 2018 - Draper Laboratory is developing implantable neurostimulation systems, 1 cubic centimeter in size, that communicate wirelessly and are wirelessly powered. The company says the implants can interface with multiple types of electrodes, and are designed to not need leads and connectors. The company cited a potential for either brain or peripheral implantation. Each neurostimulator has 32 channels for recording and stimulation. The announcement says applications could include implanting up to four networked neurostimulators. (Cision)

Company Announces 36-Month Follow-Up for Overactive Bladder Patients Who Received Tibial Nerve Stimulation

Aug. 30, 2018 - BlueWind Medical announced that in a 36-month follow-up of 20 patients who were implanted with the company's tibial nerve stimulator for overactive bladder, 75% of them experienced at least a 50% improvement in overactive bladder symptoms. (BioSpace)

Company Announces Launch of Device Registry for Neurostimulator for Drug-Resistant Epilepsy

Aug. 23, 2018 - LivaNova PLC announced it has launched a registry to evaluate its vagus nerve stimulation system in patients with drug-resistant epilepsy. Patients at up to 80 sites will be followed for up to five years, to document seizure frequency, seizure severity, quality of life, quality of sleep, antiepileptic drug use, and seizure-related emergency visits and hospitalizations. (Business Wire)

Company Announces FDA Approval of Shorter Sessions for Transcranial Magnetic Stimulation

Aug. 22, 2018 - MagVenture announced the FDA has approved a new transcranial magnetic stimulation protocol using its device for treatment of drug-resistant major depressive disorder. The protocol relies on intermittent theta-burst stimulation. Under the new protocol, sessions last about three minutes, rather than 20-30 minutes. (Medscape)

Company's Non-Invasive Stimulation System Cleared by FDA for Marketing for Obsessive Compulsive Disorder

Aug. 17, 2018 - The FDA has granted marketing clearance for treatment of obsessive compulsive disorder with a deep transcranial magnetic stimulation system by Israel-based Brainsway Ltd. The clearance for the non-invasive treatment was issued through a "de novo" approval pathway meant for low- to moderate-risk devices. (Medscape)

Percutaneous Peripheral Nerve Stimulation Systems for Pain Receive FDA Clearance

Aug. 16, 2018 - SPR Therapeutics' SPRINT peripheral nerve stimulation systems have received FDA clearance for use in pain management, the company announced. The company has single-lead and dual-lead percutaneous devices that are charged by a wearable pulse generator. The company said the systems are indicated for use for up to 60 days in the back and/or extremities for chronic and acute pain. (Medscape)

Neuromodulation Company Addressing Vision Loss Announces $5 Million Private Placement

Aug. 16, 2018 - Second Sight Medical announced a private placement in which it is selling about 3.2 million shares of common stock for $1.55 a share to entities owned by its board chair Gregg Williams. The net proceeds of about $5 million will will help support continued development, studies, and evidence-collection for its visual prosthesis systems and devices. (Mass Device)

Company Announces a 4-Year, $1 Million Preclinical Research Collaboration on Non-Invasive Vagus Nerve Stimulation and Neuroinflammation  

Aug. 9, 2018 - The company electroCore, Inc. announced it has entered a preclinical research partnership with Massachusetts General Hospital to study the mechanisms of inflammatory processes associated with central nervous system conditions, such as pain, trauma, and neurodegredation. The company will provide up to $1 million over four years for the studies, including two recently begun studies on non-invasive vagus nerve stimulation (VNS). One study focuses on persistent neuroinflammation and the neurological outcomes after concussive traumatic brain injury; the other, on effects on microglia cells and their association with the development and progression of Alzheimer’s disease. Previously, the company supported preclinical investigations at the same institution regarding neuroinflammatory mechanisms associated with migraine and their modulation by non-invasive VNS. (Globe Newswire)

Visual Prosthetics Company Reports Regulatory and Clinical Progress

Aug. 7, 2018 - Second Sight Medical Products, Inc. included updates on research and technical advances in its quarterly report for the second quarter of 2018. The company received FDA permission for a 6th feasibility subject to be implanted with its Orion™ Cortical Visual Prosthesis System. All five implanted subjects are experiencing spots of light via cortical stimulation, and one is close to being cleared for home use to begin an artificial vision rehabilitation process. The company is continuing to refine its external visual prosthetic in developing the Argus® 2s. This includes research into integrating eye-tracking and object recognition with artificial vision. The Argus II system has received a 2019 preliminary Medicare average outpatient payment rate of approximately $137,500. In the second quarter of 2018, gross profit was $1.1 million and per share, there was a net loss of $0.12. Both figures were unchanged from one year ago.  (Business Wire)

Device for Central Sleep Apnea Receives Approval for Technology Add-On Payment from the Centers for Medicare and Medicaid Services

Aug. 6, 2018 -  Respicardia, Inc. announced the Centers for Medicare and Medicaid Services approved a new technology add-on payment for its tranvenous phrenic nerve stimulation system to reduce the severity of central sleep apnea through activating the diaphragm during sleep. The additional reimbursement will go into effect Oct. 1, 2018. (Markets Insider)

Deep Brain Stimulation System Receives Expanded MRI-Conditional Approval

Aug. 2, 2018 - Abbott said it has received expanded FDA approval for MRI-conditional labeling of its Infinity deep brain stimulation system. The expansion comes in conjunction with a wireless software update. (Mass Device)

Health Canada Approves a Spinal Cord Stimulation System

Aug. 1, 2018 - Medtronic plc announced its Intellis spinal cord stimulator has received approval from Health Canada. (Mass Device)

Company Launches Second-Generation Non-invasive Vagus Nerve Stimulator

Aug. 1, 2018 - The company electroCore announced it is launching its second-generation non-invasive vagus nerve stimulator, gammaCore Sapphire. In July, the company entered the migraine market in the U.S., the announcement noted. The second-generation device is activated each month by an RFID card, similar to a hotel key card. The company said its business model calls for charging a monthly fee for the device. The announcement added that the company may later explore applications in neurology and rheumatoid arthritis. (MD+DI)

Publication Will Report on Recent Boston Neurotech Conference

July 23, 2018 - The 13th Annual Neurotech Investing and Partnering Conference in Boston, a two-day event May in Boston organized by the Neurotechnology Industry Organization and Cambridge Healthtech Institute, will be the subject of coverage in Health Europa Quarterly in August. The event had attendees from the USA, France, Australia, Israel, Japan and Switzerland, and covered treatments for neuropathic pain, epilepsy, degenerative disease and movement disorder, mental health, and emerging technologies and companies. (Health Europa)

Non-invasive Vagus Nerve Stimulation Company Strikes a Deal to Offer Telemedicine Screening

July 17, 2018 - Through a telemedicine program by UpScriptHealth, electroCore will offer its noninvasive vagus nerve stimulation therapy migraine and episodic cluster headache. Patients can use UpScriptHealth for a telemedicine consultation, and if the treatment is subsequently prescribed, a unit will be shipped to them. (Fierce Biotech)

Engineering Researchers Receive Recognition for Work to Develop MRI-Compatible Neurostimulation Leads

July 10, 2018 - University researchers in New Zealand have licensed to Saluda Medical their design for neurostimulation leads that are potentially MRI-safe, according to an announcement of a New Zealand research commercialization competition. (

Reviewers Summarize Existing and Emerging Neuromodulation Treatments for Lower Urinary Tract Conditions

July 1, 2018 - A review summarizes the current state of neuromodulation techniques, including minimally invasive or noninvasive devices, to treat bowel or bladder conditions such as overactive bladder or pelvic pain. (Urology News)

Company Announces CE Mark of an External Trial Phase Neurostimulator

July 9, 2018 - Axonics Modulation Technologies, Inc. has received CE mark for its external sacral nerve stimulation (SNS) trial system. The company's small rechargeable SNS therapeutic implant is being launched commercially in the U.K. to address overactive bladder. Meanwhile, the company has completed the enrollment and implant phase of a 120-patient pivotal clinical study in the U.S. The announcement noted that payers prefer to reimburse implant proceduress after confirming that a patient has responded to a trial phase. (Business Wire)

Device Maker Reports Progress in Clinical Trial in Chronic Disabling Low Back Pain

July 9, 2018 - Mainstay Medical International plc announced completion of all implants in its U.S. clinical study of its  implantable restorative neurostimulation system to treat disabling chronic low back pain. A total of 204 patients were implanted in the multi-center, prospective, randomized, controlled trial. Resulting data are expected to be reported at the end of 2018. (Business Wire)

Device Company Receives $108 Million in Initial Public Offering

July 6, 2018 - Neuronetics, Inc. has raised $107.5 million in an initial public offering. The company markets the NeuroStar transcranial magnetic stimulation system for treatment of medication-resistant depression. (Mass Device)

Japan Approves Implantable Device for Obstructive Sleep Apnea

June 29, 2018 - Inspire Medical Systems has won approval in Japan for its implantable neurostimulator to treat moderate to severe obstructive sleep apnea. The company said it plans to pursue reimbursement and launch the device in Japan in the second half of next year. (Mass Device)

Company Updates Anticipated FDA Submission Timeframe

June 18, 2018 - Helius Medical Technologies, Inc. now expects to submit its request to the FDA for de novo classification and 510(k) clearance in the third quarter of 2018. The company met with the FDA in April through the agency's pre-submission program and plans to meet again in July. The company's investigational device, the Portable Neuromodulation Stimulator, provides non-invasive cranial nerve stimulation, through use of a component that rests on the tongue, with physical and cognitive therapy to regain lost neurological function. (Globe Newswire)

Maker of a Transcranial Magnetic Stimulation Device Prices Its Initial Public Offering

June 15, 2018 - Neuronetics announced terms of its initial public offering. The company, which intends to expand commercialization of its transcranial magnetic stimulation device for treating depression, seeks to raise $75 million by offering 5 million shares at a price range of $14 to $16. (Renaissance Capital)

Tibial Nerve Stimulation System Study Design for Patients with Overactive Bladder is Approved by the FDA

June 14, 2018 - The FDA has approved the proposed study design for BlueWind Medical's battery-less, miniature, implantable tibial nerve neuromodulation system intended for the management of overactive bladder (OAB). The OAB neurostimulation study, OASIS, will seek to enroll 250 patients at up to 25 medical centers in the UK, the Netherlands, Belguim, and Germany. The design calls for assessing the number of responders at 6 months, and following patients for 12 months to assess safety and durability of the potential effect. The device received CE mark for OAB in 2016. (MD Magazine)

Company's Physician Programmer Receives FDA Approval

June 13, 2018 - Medtronic said it has won FDA approval for its deep brain stimulation programmer and associated software for its Activa rechargeable system. (Mass Device)

FDA Clears Neurostimulation Device for Reduction in Opioid Withdrawal Symptoms

June 12, 2018 - The FDA has provided clearance for an auricular neurostimulation device, Drug Relief, by DyAnsys Inc. for treatment of opioid withdrawal symptoms. The symptoms include anxiety, agitation, depression, nausea, and opiate cravings. The company said the device is used for 120 hours and may begin reducing symptoms within an hour. It is available by prescription for patients undergoing opioid detoxification. (MD Magazine)

Brain-Machine Interface Startup Receives $7 Million in Seed Funding

June 11, 2018 - A California startup, Paradromics, has received $7 million in seed funding to develop brain-machine interface technology. The company wants to initially develop a way for people with locked-in syndrome to communicate. Earlier, it received $18 million from the U.S.Defense Advanced Research Projects Agency. The company is working on sensors for the cerebral cortex. (Fierce Biotech)

Neurostimulation Company Announces Product Launch in Canada

June 11, 2018 - Bioness said its StimRouter neuromodulation system has been implanted in the first procedures in Canada, at Toronto’s Women’s College Hospital.The minimally invasive peripheral nerve stimulation device is designed to provide adjunctive treatment for chronic pain. (Mass Device)

Non-Invasive Brain Stimulation Device Company Sets Terms for Initial Public Offering

June 5, 2018 - ElectroCore, which makes a non-invasive device to treat migraine, announced terms for its initial public offering. The company seeks to raise $65 million, and will offer 4.3 million shares in a price range of $14 to $16. (Nasdaq)

Company Wins Patent for Neurostimulation with Potential Promise in Diabetes

June 5, 2018 - ReShape Lifesciences announced it has been granted a U.S. patent for devices and methods that provide combined blocking and stimulation of the vagus and celiac nerve branches that innervate the pancreas and liver. The company's product portfolio encompasses treatment of obesity and metabolic disease. The newly patented innovation was shown in a rat model of diabetes to provide better glycemic control, an important factor in diabetes. (Vision)

Company's Deep Brain Stimulation System Now Available in South Korea

June 5, 2018 - Boston Scientific Corporation announced it is now providing its Vercise deep brain stimulation system in South Korea for patients with movement disorder. The system gained reimbursement there beginning June 1. (Korea Biomedical Review)

Device Maker Announces Launch of Next-Generation Closed-Loop Neurostimulator for Epilepsy

June 1, 2018 - NeuroPace, Inc. announced the first patient with medication-resistant epilepsy has been implanted with its Next Gen RNS System, which has been designed with a longer battery life and more memory. The company's neurostimulation device monitors brain activity for patterns that suggest a seizure onset, and applies stimulation before seizures occur. (Business Wire)

Comment Period Opens About Vagus Nerve Stimulation for Treatment-Resistant Depression

May 30, 2018 - The U.S. Centers for Medicare & Medicaid Services has opened a 30-day comment period after it was formally requested by LivaNova PLC to reconsider its decade-old national non-coverage determination for the company's vagus nerve stimulation system for treatment-resistant depression. The company said significant evidence of the treatment's effectiveness in this indication has emerged over that last decade, and that coverage would aid patients and physicians. (Business Wire)

Neurostimulator Study Showed Improvements in Pain, Disability, and Quality-of-Life Scores Over Baseline

May 25, 2018 - International Neuromodulation Society member Vivek Mehta, FRCA, MD, FFPMRCA, presented results of a single-arm prospective safety and efficacy trial of an implantable neurostimulation system to address disabling chronic refectory low back pain, ReActive8-A, during the World Congress of the World Institute of Pain in Ireland in May. To restore stability of the lower back, the device stimulates muscle contractions of the lumbar multifidus. There were 53 enrollees in the trial, who were followed for up to one year. Pain scores improved by 33%±6% at one year, and 94% of patients had a clinically significant improvement in pain, with improvements in disability and quality of life at 86% and 87% respectively. (NeuroNews)

Company Plans Initial Public Offering

May 21, 2018 - ElectroCore filed Monday for a $75 million initial public offering on the Nasdaq, planning to trade under the symbol ECOR. Pricing details were not disclosed. (Nasdaq)

Device Company Announces CE Mark Approval for Wirelessly Powered Sacral Nerve Stimulator

May 17, 2018 - StimGuard LLC announced it received CE Mark approval of its wirelessly powered sacral nerve stimulation system to treat intractable symptoms of overactive bladder. The company plans to launch sales of the device in the European Union in the summer. (Mass Device)

Data Presented Concerning Non-invasive Vagus Nerve Stimulation to Treat Migraine Attacks

May 17, 2018 - International Neuromodulation Society member Peter Staats, MD, described findings presented at the American Academy of Neurology annual meeting about treatment of migraine and episodic cluster headache through noninvasive vagus nerve stimulation, using an FDA-cleared device by electroCore, where he is chief medical officer. The results of a randomized, double-blind trial in 243 migraine patients showed the gammaCore device outperformed sham in treating a migraine attack at 30 and 60 minutes. The hand-held device was also shown to be better than sham at 120 minutes in a post hoc repeated-measures analysis. (Healio)

Company's Deep Brain Stimulator Receives Approval in U.S. for Epilepsy

May 1, 2018 - The U.S. FDA has granted premarket approval for adjunctive use of Medtronic's deep brain stimulation therapy for adults with medically refractory, partial-onset epilepsy. (MD Magazine)

FDA Clears Non-Invasive Stimulator for Essential Tremor

April 26, 2018 - A wrist-worn, non-invasive stimulator for transient relief of hand tremors in essential tremor has received clearance from the U.S. FDA. The device by Cala Health delivers patterned electrical stimulation through the skin. (Cala Health)

Introductory Video Attempts to Demystify Deep Brain Stimulation Technology

April 27, 2018 - Abbott has produced an overview video showing deep brain stimulation (DBS) devices. The video calls DBS "a mind-blowing technology that's changing the future of healthcare." (Diversity Inc.)

One-Year Results Presented for U.S. Multi-Center Study of Deep Brain Stimulation in Parkinson's Disease

April 24, 2018 - Boston Scientific Corp. announced one-year results from its INTREPID study of deep brain stimulation for Parkinson's disease, a prospective, double-blind, randomized, sham-controlled study. There were 292 patients enrolled at 23 U.S. centers. The data showed a 49.2% improvement in motor symptoms and longer "on" time and improved quality of life. The results were presented at the American Academy of Neurology annual meeting. (Markets Insider)

Company Whose Neurostimulator Addresses Sleep Apnea Looks to Raise $75 Million in Offering

April 23, 2018 - Terms of the initial public offering for Inspire Medical Systems were announced, with the device maker, which sells a neurostimulation system for obstructive sleep apnea, planning to raise $75 million by offering 5 million shares in a price range of $14 - $16. (Renaissance Capital)

Acquisition Complete of Device Maker That Addresses Overactive Bladder

April 23, 2018 - The acquisition of Cogentix Medical, Inc. was completed by Laborie Medical Technologies at $3.85 per share. Cogentix, now a subsidiary, created the percutaneous tibial nerve stimulation system Urgent PC to address symptoms of overactive bladder. (The Virginian-Pilot)

Company Plans Study of Non-Invasive Stimulation Following Traumatic Brain Injury

April 18, 2018 - Endonovo Therapeutics, Inc. announced it will begin a clinical research study of a non-invasive pulsed electromagnetic field device to lower neuroinflammation after traumatic brain injury. The study at the University of New Mexico Health Sciences Center will entail neurological follow-up at one and three months. (Uptick Newswire)

Quarterly Earnings Report Reflects Growth in Spinal Cord Stimulator Sales

April 18, 2018 - Abbott has attained the No. 1 sales position in the U.S. for spinal cord stimulation devices, industry analysts said at the conclusion of the first quarter of 2018. The company's $212 million in neuromodulation device sales represented nearly 19% organic growth. The neuromodulation business is expected to grow, but not necessarily spike, according to comments the CEO made during a quarterly earnings call. (Star Tribune)

Vagus Nerve Stimulation System for Epilepsy Receives CE Mark Approval in Europe

April 17, 2018 - LivaNova announced it has received CE mark approval for its vagus nerve stimulation system for treatment of drug-resistant epilepsy in the European Union. (Mass Device)

Bioelectronic Medicine Executive Discusses Therapy Potential

April 17, 2018 - The CEO of SetPoint Medical writes about medical devices playing a role in treating inflammatory disease through bioelectronic medicine. The company has begun clinical trials in rheumatoid arthritis and Crohn's disease, and has explored potentially addressing multiple sclerosis. (Mass Device)

Company Begins Listing on Public Stock Exchange

April 11, 2018 - Helius Medical announced a public offering on NASDAQ of 4.14 million shares at $7.47 per share, totaling $14.1 million. The proceeds will be used for commercialization activities for its portable neuromodulation stimulator device. The company anticipates regulatory submissions this quarter in the U.S., Canada, Australia, and the European Union. Potential indications include physical rehabilitation for brain injury or neurological conditions. (Medical Device Investing News)

Noninvasive Neurostimulator Launches in the United Kingdom

April 11, 2018 - The South African company Xavant Technology (Pty) Ltd. announced the launch, in the United Kingdom, of a noninvasive nerve stimulation device for relief of neuropathic pain and adjunctive treatment of post-surgical pain, post-traumatic acute pain problems, and pain control in rehabilitation. (Cision)

News Article in Nigeria Presents State of China-Made "Brain Pacemaker"

April 10, 2018 - International Neuromodulation Society member Luming Li, PhD, commented in an article about the spread of deep brain stimulation for Parkinson's disease in China, saying it has become an important method to treat patients in the middle and late stages. The article said the first China-made devices became available in China in 2009, and have been introduced to such countries as Pakistan, Bangladesh and Indonesia. (World Stage)

Device Maker Files Initial Public Offering

April 9, 2018 - Inspire Medical Systems Inc., whose neurostimulator to address obstructive sleep apnea received U.S. regulatory approval in 2014, has filed for an initial public offering to raise $86.2 million. (Minneapolis/St. Paul Business Journal)

Wearable Pain Relief Device Gathers Data

April 4, 2018 - NeuroMetrix began providing a wearable neurostimulation device for pain control in 2015, and gathers automated and self-reported data from about 50,000 contributors. In an interview, the CEO said the company has begun to analyze the digital health data that these contributors provide. (Medgadget)

Sacral Nerve Stimulation Developer Announces New Financing

April 3, 2018 - Axonics Modulation Technologies raised $40.1 million in financing. An equity offering provided $20.1 million and the remainder came from a new credit facility. The financing will support further commercial development of its sacral nerve stimulation system, which is intended to treat bladder and bowel disorders. (Mass Device)

Company Reports Findings Involving Its Hand-held Migraine Prevention Device

April 3, 2018 - The company eNeura reported publication in Cephalgia of findings from its migraine prevention study. The study at eight U.S. centers evaluated its handheld transcranial magnetic stimulation device. (Cision)

Gym Tries Out Consumer Transcranial Direct Current Stimulation Device

April 2, 2018 - A Hong Kong gym tried out a consumer headset that provides transcranial direct current stimulation. The month-long assessment concerns fitness-related technology that might be distributed to locations throughout the city. The article concludes that the device's novelty may spark motivation and the gains are an incremental effect. (South China Morning Post)

Patient Enrollment Begins in Feasibility Trial of "Microburst" Vagus Nerve Stimulation in Epilepsy

March 28, 2018 - LivaNova announced the first patient has been enrolled in its feasibility trial of its microburst vagus nerve stimulation system in epilepsy. (Mass Device)

Meeting Recap Discusses Recently Approved Neurostimulator

March 23, 2018 - Several potential pain indications were presented at the 2018 annual meeting of the North American Neuromodulation Society for Nevro's Senza II spinal cord stimulation system, which received FDA approval in January. The potential indications include chronic, intractable neck and/or upper limb pain; peripheral polyneuropathy; and nonsurgical refractory back pain. (Pain Medicine News)

Company Starts Trial of Vagus Nerve Stimulation in Rheumatoid Arthritis

March 26, 2018 - SetPoint Medical announced it has begun a pilot trial in 15 subjects with drug-refractory rheumatoid arthritis in the U.S. The trial at seven centers will evaluate its rechargeable wireless vagus nerve stimulator that is intended to activate the body's anti-inflammatory reflex. (Business Wire)

Device Maker Announces MRI-Conditional Labeling

March 23, 2018 - Nevro said it received FDA approval for full-body MRI-conditional labeling for its Senza spinal cord stimulation system. (Mass Device)

New Stimulation System for Cluster Headache Implanted at U.K. Center

March 21, 2018 - International Neuromodulation Society member Ashish Gulve, MD, was quoted in an article that announced use of a new device for occipital nerve stimulation. The AnkerStim lead and neurostimulation system was used in a patient in the U.K. who has cluster headache. (Gazette)

Column Introduces a Neurostimulation Device for Obstructive Sleep Apnea

March 21, 2018 - An article describes a new device, available in Utah for moderate to severe obstructive sleep apnea, that is implanted on an outpatient basis. (The Spectrum)

Company Plans Clinical Trial of Stimulator for Knee Replacement Pain Management

March 19, 2018 - Bioelectronics Corporation announced it is beginning a clinical trial in 40 subjects undergoing knee replacement. In it, patients will be randomized to receive a sham or active device for postoperative pain management and reducing hypersensitization during recovery. The device, RecoveryRx, delivers "pulsed shortwave therapy" at 27.12Mhz. Patients in the study, to take place at New Mazloum Hospital in Tripoli, Lebanon, will be followed for three months. (Nasdaq)

Medical Center Announces State's First Implantation of a Recently Approved Vagus Nerve Stimulation Device for Refractory Epilepsy

March 14, 2018 - West Virginia University Medicine announced the first implantation in the state of LivaNova's vagus nerve stimulation system for medication-resistant epilepsy. (WVNews)

Device Company Outlines Plans for Its Spinal Cord Stimulation Systems, Sacral Nerve Stimulators, and Development of Deep Brain Stimulation Systems

March 13, 2018 - Nuvectra Corporation CEO Scott Drees was interviewed during the North American Neuromodulation Society meeting in January. In the interview, he said the company reached 1,000 implants of its spinal cord stimulation device Algovita in the U.S. in December 2017. The company is now talking about a four-arm clinical study comparing stimulation modes for the device. Meanwhile, it anticipates European approval of its sacral nerve stimulation system Virtis in the second quarter of 2018 and in the U.S., in the second half of 2018. Finally, the company has a development agreement with Aleva Neurotherapeutics to combine Nuvectra's implantable pulse generator technology with Aleva's lead technology, to create a deep brain stimulation system. (SmartTRAK)

Government Program in France Will Help Fund a Study of Neurostimulation in Cluster Headache

March 13, 2018 - Autonomic Technologies announced the French National Authority for Health will support a randomized controlled trial of the company's sphenopalatine ganglion stimulation system in patients with cluster headache. The funding comes through the Forfeit innovation program, which is designed to accelerate introduction of promising medical technology and collect data for a longer-term reimbursement decision. (NeuroNews)

Maker of a Neurostimulation System for Overactive Bladder Strikes Acquisition Agreement

March 12, 2018 - Cogentix Medical, the maker of the percutaneous tibial nerve stimulation system Urgent PC Neuromodulation System, has agreed to be acquired for $239 million in cash to become a wholly owned subsidiary of Laborie Medical Technologies. The acquisition represents a per-share premium of 28% over the average closing price of the company's stock over the last 30 days. The deal is expected to be completed early in the second quarter of 2018. (

Company Plans Clinical Trial of Implanted Tibial Nerve Stimulator for Overactive Bladder

March 9, 2018 - Valencia Technologies Corporation said it has won FDA approval to launch a pivotal clinical trial to evaluate its eCoin neurostimulation device in the treatment of overactive bladder. About the size of a nickel, the device would be implanted subcutaneously above the tibial nerve. The eCoin has electrodes integrated into its housing, which contains a small battery that is designed to deliver intermittent stimulation. (Mass Device)

Business Column Describes Evolving Definition of Bioelectronic Medicine

March 2018 - A column describes bioelectronic medicine as being geared toward improving organ function, and suggests the taxonomy may later be based upon physiology rather than technology. It also raises the concept of "pricing device therapies by the dose, rather than hardware cost," which would be more familiar to professionals who originally worked in biopharmaceutical development. (Neurotech Reports)

U.S. Health Insurer to Cover Peripheral Nerve Stimulator

March 7, 2018 - Bioness Inc. announced its StimRouter peripheral nerve stimulation system has received coverage from Highmark Blue Cross Blue Shield, the fourth-largest Blue Cross Blue Shield provider in the U.S., for chronic intractable neurogenic pain. (PR Newswire)

More States Will Provide Medicare Reimbursement for Company's Retinal Prosthesis

March 6, 2018 - Second Sight Medical announced expanded Medicare reimbursement coverage for its Argus II retinal prosthesis system for patients with retinitis pigmentosa. This new coverage from Medicare Administrative Contractor Palmetto GBA applies to Alabama, Georgia and Tennessee. The coverage area now totals 31 states, two territories, and the District of Columbia. (Mass Device)

Device Maker Announces Plans for Comparative Study of Nerve Stimulation Devices in Overactive Bladder Syndrome

Feb. 28, 2018 - StimGuard LLC announced it will initiate a U.S. head-to-head study of its implantable percutaneous tibial nerve stimulator, compared to sacral nerve stimulation, to address urgency urinary incontinence, in patients with refractory overactive bladder syndrome. (Business Wire)

Television Producers Plan a Special Feature on Emerging Neuromodulation Technology

Feb. 22, 2018 - The television show Innovations plans to feature "the future of neuromodulation" in an upcoming show about the innovation of mid-field power, according to Neurspera Medical Inc., which is developing the technology to power medical devices. (PR Web)

Device Maker Increases Access to Capital to Support Planned Expansion of Sales, Markets

Feb. 20, 2018 - Nuvectra Corporation announced an amended loan and security agreement of three tranches totaling $45 million, with an extended amortization period that goes to 2020. The company said it will use the agreement to expand U.S. sales of its spinal cord stimulation system, Algovita, and plan an entry into the sacral neuromodulation market. (Globe Newswire)

Company to Open New Manufacturing Facility for Neuromodulation Platform Technology

Feb. 20, 2018 - Med-Ally, which manufactures the VersaStim neuromodulation platform technology, plans to open a $2.38 million, 10,000 square foot facility in South Carolina next month that is expected to add 90 jobs to the company, which was founded seven years ago and reportedly has fewer than 50 employees. (Medical Design & Outsourcing)

Journal Articles Summarize a Clinical Trial of a Rechargeable Sacral Neuromodulation System

Feb. 20, 2018 - Axonics Modulation Technologies, Inc. announced publication of three clinical articles regarding a European clinical trial of its rechargeable sacral neuromodulation system in the Journal of Neurourology and Urodynamics. The articles include three-month follow-up results in 51 patients with overactive bladder. The data show that 31 of the 34 patients who responded to a trial period continued to show improvement at three months. (Business Wire)

Device Company Raises Funds to Complete Testing of Its Vagus Nerve Stimulation Device for the Treatment of Epilepsy

Feb. 19, 2018 - Neurostimulation company Synergia Medical SA announced it has raised €8.1 million in a Series A funding. The company intends to use the funding to complete testing of its vagus nerve stimulation device for medication-resistant epilepsy, NAOS, prior to CE mark submission. (Nasdaq)

Company: Critical Limb Ischemia Improved in Preclinical Study

Feb. 12, 2018 - Endonovo Therapeutics, Inc. announced positive results in a study investigating the effects of its pulsed electromagnetic field device on critical limb ischemia in mice. (Globe Newswire)

Company Raises $17 Million for Commercialization of Non-Invasive Stimulator for Migraine

Feb. 6, 2018 - The medical device company eNeura Inc. received a $17 million investment round to expand marketing of its hand-held transcranial magnetic stimulation device for the treatment of migraine. The device is leased to patients on a trial basis for three months for $450, with a total of $750 to continue an additional three months. It can also be rented on an annual basis. (Baltimore Sun)

Company Announces Progress in Its Portfolio of Visual Prostheses

Feb. 5, 2018 - International Neuromodulation Society member Nader Pouratian, MD, PhD, implanted a visual prosthetic that stimulates the visual cortex, the Orion Visual Cortical Prosthesis System, in January. The patient was the first to receive the implant in a feasibility clinical study by Second Sight Medical Products, Inc. The system is intended to restore some useful vision to patients who have lost sight due to a variety of reasons, such as glaucoma, diabetic retinopathy, or forms of cancer and trauma. The company added that its Argus II Retinal Prosthesis System, for patients with vision loss from retinitis pigmentosa, was implanted in 75 patients worldwide in 2017. (Second Sight)

U.S. Sales Begin of Central Sleep Apnea Device

Feb. 2, 2018 - Respicardia, Inc. announced the first commercial case of its transvenous phrenic nerve stimulator, the remedē System, being implanted in the U.S. to treat central sleep apnea. The company added that it has named industry veteran Peter Sommerness CEO, responsible for guiding its U.S. launch of the device. (Markets Insider)

First Patient Receives Sub-Retinal Implant in Visual Prostheses Study

Jan. 25, 2018 - Pixium Vision announced the first implantation and activation of its miniaturized wireless photovoltaic sub-retinal implant, PRIMA, in a patient with vision loss from dry age-related macular degeneration, as part of a stud to assess the implant's safety and performance in eliciting central visual perception. Up to five patients will be recruited for the study, which involves a re-education phase for the patient and follow up at six and 36 months. (Business Wire)

Device Maker Plans a Follow-On Stock Offering

Feb. 1, 2018 - Nuvectra Corporation announced a follow-on offering of 2,825,000 shares of common stock at a price of $8 a share. The offering is expected to close on or about Feb. 5, 2018. (Street Insider)

Neurostimulation Headset Maker Raises $13 Million

Jan. 31, 2018 - Halo Neuroscience, which is marketing a neurostimulation headset to reinforce motor training and athletic performance, has raised $13 million in series B financing. After sports applications, the company said, it may branch out into augmenting rehabilitation or cognitive function. (MobiHealthNews)

External Vagus Nerve Stimulator Approved for Relief of Migraine Pain

Jan. 29, 2018 - The FDA has approved the hand-held vagus nerve stimulator, gammaCore, by electroCore LLC, for the treatment of migraine pain in adults. The device was approved for episodic chronic headache pain in April 2017. (Medscape)

Peripheral Nerve Stimulator Receives Canadian Approval

Jan. 29, 2018 - Bioness, Inc. has received approval from Health Canada to provide its peripheral neurostimulation system, StimRouter, for treatment of chronic peripheral nerve pain, excluding the cranial facial region. (Markets Insider)

Startup Founder Explores the Middle Eastern Market for a Gastric Electrical Stimulator

Jan. 28, 2018 - An interview details plans to commercialize the Intrapace closed-loop gastric electrical stimulator for obesity in the Middle East. (The National)

Startup Plans to Develop Transcranial Direct Current Stimulation for Depression

Jan. 26, 2018 - A startup, Flow Neuroscience, backed by $1.1 million in seed funding, will combine a wearable brain stimulation device and behavioral training program with the intent to address depression. The device is being designed to deliver transcranial direct current stimulation. Based in Sweden, Flow Neuroscience announced plans to seek European market approval. (Fierce Biotech)

Company Plans Phase 3 Clinical Trial of External Neurostimulation Device to Abort Migraine Attacks

Jan. 25, 2018 - Cefaly Technology announced it plans a Phase 3 trial of its external trigeminal nerve stimulator as a first-line abortive treatment for migraine. The company said data to date show the treatment outperforming abortive migraine medication. (Mass Device)

Health Insurer Starts Trial of Transcranial Magnetic Stimulation in Medication-Resistant Depression

Jan. 25, 2018 - In Australia, the insurer Medibank is funding a national, 12-month-long trial of up to 500 patients to assess the efficacy and cost-effectiveness of transcranial magnetic stimulation (TMS) in medication-resistant depression. The trial follows an Adelaide University study that concluded it can be an effective treatment, in addition to a finding in the U.S. that TMS was effective in 58% of patients with medically refractory depression. The treatment has been available in Australia for about 10 years at a cost of about AUS$3,600. There were two prior attempts to add TMS to the reimbursement schedule of the country's public healthcare system, Medicare. The insurer's chief medical officer is quoted as calling it a "simple and easy" treatment "for a significant disease area." Currently 70 patients have been enrolled. (The Advertiser)

Neurostimulation Registry Shows Symptom Improvement in Cluster Headache Patients

Jan. 25, 2018 - Autonomic Technologies, Inc. announced results of a prospective registry study published in The Journal of Headache and Pain showing that in 85 cluster headache patients who were followed for one year, sphenopalatine ganglion (SPG) stimulation reduced frequency and/or pain of cluster headache attacks in 68% of patients. The company's SPG neurostimulator is CE marked in Europe and under study in the U.S. for acute relief of chronic cluster headache. (Cision)

Silicon Valley Company That is Developing Mid-Field Power for Neuromodulation Raises $26 Million

Jan. 24, 2018 - Neurspera Medical Inc., which is developing implantable mid-field powering technology for neuromodulation applications, closed a $26 million round of Series B financing. The privately held company in based in San Jose, Calif., USA. (Vision)

Medical Technology Company Acquires Neurostimulation Company and Its Hypoglossal Nerve Stimulation System

Jan. 23, 2018 - LivaNova closed a $225 million buyout of ImThera Medical. ImThera's hypoglossal nerve stimulator for obstructive sleep apnea received FDA clearance for a clinical study that is expected to be completed by March. LivaNova, which had already invested in ImThera, paid $78 million to acquire the rest of the company and pledged an additional $147 million based on regulatory and sales milestones. (Mass Device)

Non-Invasive Brain Stimulation System Company Receives R&D Loan

Jan. 23, 2018 - Nexstim Plc announced it has received a research-and-development loan of approximately EUR 1 million codevelop a next-generation user interface for its navigated transcranial magnetic stimulation system to treat major depressive disorder and chronic neuropathic pain. (Nasdaq)

Two-Year Data Presented Concerning a Spinal Cord Stimulation System that Offers a "Burst" Mode

Jan. 15, 2018 - Two-year outcome data were presented at the annual meeting of the North American Neuromodulation Society concerning Abbott Laboratories' Sunburst trial of its Proclaim spinal cord stimulation system. The data reflected the extent to which the 42 pain patients who were followed preferred either tonic stimulation, or a "burst" mode option. (Star Tribune)

Clinical Data Presented Regarding Two Companies' Neuromodulation Devices

Jan. 12, 2018 - An article covers announcements by Medtronic plc and Boston Scientific Corporation about studies the companies presented at the annual meeting of the North American Neuromodulation Society. Medtronic announced results of its Sisters study that compared treatment for spasticity after a stroke using either oral baclofen or baclofen delivered intrathecally with the company's implantable intrathecal drug delivery system, SynchroMed II. Boston Scientific presented data from its randomized controlled clinical trial, Whisper. The data showed a difference in how many patients could effectively control their pain with the company's Precision spinal cord stimulation device by either being limited to a single stimulation mode or having a choice of two different stimulation modes.

Company Announces Presentation of Data from Studies of High-Frequency Spinal Cord Stimulation

Jan. 12, 2018 - Nevro Corp. announced presentations at the annual meeting of the North American Neuromodulation Society. These include data regarding a study of the company's high-frequency spinal cord stimulation in intractable neck and/or upper limb pain; a study of the device in peripheral polyneuropathy that has led to a new trial in painful diabetic neuropathy; and a study in non-surgical refractory back pain. (Medical Device News Magazine)

FDA Approval Announced for Spinal Cord Stimulator that Varies Frequency, Pulse Width, and Amplitude

Jan. 11, 2018 - Boston Scientific Corporation announced pre-market approval from the FDA for its spinal cord stimulation device that permits varying frequency, pulse width and amplitude, the Spectra WaveWriter. (Mass Device)

Peripheral Nerve Stimulator Data Presented in Poster Sessions

Jan. 11, 2018 - Bioness, Inc. announced that data from four studies will be presented during poster sessions at the annual meeting of the North American Neuromodulation Society about its peripheral nerve stimulator, StimRouter. The studies concern use of the device for chronic pain originating from the peripheral nerve region of the shoulder, tibia and other areas of the body. (Markets Insider)

FDA Approves Changes to Intrathecal Drug Delivery Device

Jan. 10, 2018 - The FDA has approved design changes and a new programming interface for Medtronic plc's SynchroMed II intrathecal drug delivery device. (Start Tribune)

Company Plans Post-market Study of Its Neurostimulation Therapy Workflow

Jan. 10, 2018 - Medtronic plc has enrolled its first patient in a prospective, multi-center post-market study of its Evolve workflow that it says standardizes guidance that balances spinal cord stimulation settings between high-dose and low-dose. The study will follow up to 175 chronic pain patients treated with this SCS system at up to 25 U.S. sites for one year. (MD+DI)

Neurostimulation Device Company Plans Product Launch

Jan. 10, 2018 - Stimwave LLC announced it has agreed to more than $50 million in additional financing to launch its wireless neurostimulator for chronic pain. The company plans a consumer event March 1 in Columbus, Ohio, at the the First Annual Medical Conference for Recovery, Regeneration, and the Athlete, as part of the launch. (Business Wire)

Temporary Electrical Stimulator to Treat Patients on Mechanical Ventilation Receives CE Mark

Jan. 8, 2018 - Synapse Biomedical Inc. announced CE mark approval of its temporary diaphragm stimulator for patients in the intensive care unit. The device is a percutaneous intramuscular electrical stimulator. Its use in patients who are on mechanical ventilation is meant to minimize atrophy of the muscle and treat ventilator-induced diaphragm dysfunction. (Business Wire)

Spinal Cord Stimulation System Receives FDA Approval

Jan. 8, 2018 - The FDA has approved Nevro Corporation's updated spinal cord stimulation system with a reduced-size implantable pulse generator, Senza II. (MD Magazine)

Rechargeable Sacral Neuromodulation System Receives Australian Approval

Jan. 8, 2018 - Axonics Modulation Technologies, Inc. announced it has received marketing approval in Australia for its rechargeable sacral neuromodulation system to treat overactive bladder, fecal incontinence and urinary retention. The device has been approved in Europe and Canada and is undergoing a pivotal U.S. study designed to support an application for pre-market approval there. (Business Wire)

Study Evaluates Brain Effects of Non-Invasive Neurostimulation Device

Jan. 8, 2018 - Helius Medical Technologies, Inc. announced that a study in 20 healthy volunteers showed its non-invasive, investigational device that delivers neurostimulation through the tongue exerted statistically significant changes in brainwave activity as observed in EEG. For instance, during a 20-minute rest period following a 20-minute session of high frequency stimulation, alpha and theta brainwaves increased. The study evaluated high frequency and low frequency stimulation, in random order, in single sessions one week apart. (Nasdaq)

Enrollment Complete in Stroke Rehabilitation Study

Jan. 6, 2018 - Nexstim Plc has completed enrollment in a supplementary Phase III clinical trial that evaluates its navigated transcranial magnetic stimulation system in post-stroke rehabilitation of upper extremity function. (Globe Newswire)

Multi-Year, Multi-Site Post-Market Study Begins of Implanted Vagus Nerve Stimulation as an Adjunctive Treatment in Treatment-Resistant Depression

Jan. 4, 2018 - Livanova PLC announced it has enrolled its first patient in a post-market study of implanted vagus nerve stimulation as an adjunctive treatment for patients with difficult-to-treat depression. The study, RESTORE-LIFE, will enroll at least 500 patients at up to 80 sites outside the U.S., and follow-up will run from three to five years. (Markets Insider)

Six-Month Results Published in Study of an Implanted Tibial Nerve Stimulator to Manage Symptoms of Overactive Bladder

Jan. 4, 2018 - BlueWind Medical announced publication of 6-month study results of its implantable tibial nerve stimulator in patients with refractory overactive bladder. The authors reported that 71% of the 34 patients who competed the study experienced at least a 50% reduction in symptoms. (

Company Announces the First Enrollees have Begun Receiving Implants in a Clinical Trial of a Rechargeable Sacral Neuromodulation System

Jan. 3, 2018 - Axonics Modulation Technologies, Inc. announced the first 11 patients were implanted in the U.S. and Europe in its clinical study of its rechargeable sacral neuromodulation system for the treatment of urinary and bowel dysfunction. The study is designed to prepare an application for premarket approval in the U.S. (Digital Journal)

Company Acquires Neuroscience Startup's Intellectual Property and Assets

Dec. 27, 2017 - Endonovo Therapeutics bought intellectual property and assets from Rio Grande Neurosciences for $3 million cash and a $1.5 million promissory note due Nov. 30, 2018. Rio Grande's device to treat pain and edema using pulsed electromagnetic fields (PEMF) has been CE marked and received FDA approval. The company also has a multi-coil repetitive transcranial magnetic stimulation device that is pending FDA marketing clearance. Endonovo said it will pursue clinical trials of PEMF in traumatic brain injury, post-concussion syndrome, stroke, and multiple sclerosis. (Mass Device)

Company Addressing Central Sleep Apnea Raises $58.5 Million

Dec. 18, 2017 - Respicardia, Inc., which plans a U.S. launch of its FDA-approved phrenic nerve stimulator for central sleep apnea, announced it has closed a $58.5 million round of financing. (Markets Insider)

Device Company Targeting Chronic Low Back Pain Passes Early Milestone of U.S. Clinical Trial

Dec. 11, 2017 - Mainstay Medical plc announced an interim analysis of the first 58 patients to complete its U.S. clinical trial showed no safety concerns with the company's implantable device for chronic low back pain. The analysis was carried out by an independent data committee that also recommended achieving a final sample size of 168 evaluable patients. The company expects to reach full enrollment by the second quarter of 2018. (Irish Times)

Technology Publication Recognizes a Company for Developing a Sacral Neuromodulation System

Dec. 11, 2017 - Axonics Modulation Technologies is one of 15 companies named a "Fierce 15" by the publication Fierce Biotech for 2017. The company is developing a rechargeable, miniaturized implantable device to provide sacral neuromodulation for overactive bladder. A U.S. clinical trial is beginning enrollment this month. (Fierce Biotech)

FDA Approves Rechargeable Deep Brain Stimulation System with Independent Current Control

Dec. 11, 2017 - Boston Scientific Corp. announced FDA approval of its deep brain stimulation system to address symptoms of Parkinson's disease with electrodes that have independent current control. U.S. approval was based on a multi-center, randomized, controlled, prospective, double-blind study of 292 Parkinson's disease patients at 23 sites in the United States. Data from the Intrepid study are expected to be released in 2018. The filing included additional safety data from an earlier study in Europe, where the rechargeable system launched in 2012. (PR Newswire)

FDA Permits Clinical Trial of Vagus Nerve Stimulation in Rheumatoid Arthritis

Dec. 11, 2017 - Setpoint Medical Corp. received FDA approval to start a clinical trial of 15 subjects at seven U.S. centers to evaluate its implantable vagus nerve stimulator in medication-resistant rheumatoid arthritis. The stimulation is intended to activate an anti-inflammatory pathway. (Mass Device)

Trancranial Magnetic Stimulation Device Maker Raises $8.5 Million

Dec. 11, 2017 - Brainsway Ltd. has raised $8.5 million from financial institutions in Israel. The company produces transcranial magnetic stimulation devices for the treatment of depression. Brainsway is awaiting a decision from the U.S. FDA about potentially marketing its device for treatment of obsessive compulsive disorder. The company is also anticipating results in late 2018 of a smoking cessation study. (Globes)

Company Receives Recognition from a Biotechnology Industry Publication

Dec. 11, 2017 - An article describes Saluda Medical's spinal cord stimulator, a closed-loop device, as moving toward personalized, precision-based medicine. The company was one of 15 named as a "Fierce 15" for 2017 by the publication Fierce Biotech. (Fierce Biotech)

U.S. Centers for Medicare & Medicaid Service Will Increase Reimbursement in January for Peripheral Nerve Stimulator Implantation

Dec. 7, 2017 - Bioness, Inc. announced that starting Jan. 1, 2018, the U.S. Centers for Medicare & Medicaid Service has approved increased payments for implantation of its percutaneous neurostimulator that addresses chronic pain of peripheral nerve origin. The increased reimbursement will be 11% at outpatient hospitals, 3% at ambulatory surgery centers, and 124% at physician offices. (PR Newswire)

Device Maker Announces Acquisition

Dec. 5, 2017 - LivaNova, PLC has agreed to acquire ImTherra Medical and its implantable sleep apnea treatment in a transaction valued at $225 million. The sleep apnea device is available in Europe and the FDA has granted permission for a U.S. pivotal trial. (Mass Device)

Neurostimulation Findings Presented at Annual Epilepsy Meeting

Dec. 5, 2017 - NeuroPace, Inc., issued a news release announcing five poster presentations at the American Epilepsy Society annual meeting. The prospective data being presented came from 256 neurostimulation patients with an average follow-up of eight years. The company noted that its responsive neurostimulation system has accumulated more than 1.5 million stored brain recordings, which could potentially provide clinical insight into the condition and its treatment. (Business Wire)

Visual Prostheses Company Begins Implantations in Iran

Dec. 5, 2017 - In Iran, Second Sight Medical has launched its second-generation retinal prosthesis system, which has already been implanted in two patients there. (Mass Device)

Company Releases Its Next Transcranial Magnetic Stimulation Platform

Dec. 5, 2017 - The Magstim Company Ltd. announced release of a next-generation transcranial magnetic stimulation platform for treatment medication-resistant major depressive disorder. (PR Newswire)

Publisher Provides INS Members Access to an Enhanced Database of Neuromodulation Products

November 2017 - Neurotech Reports announced it is enhancing its Database of Neuromodulation Products, which is available to members of the International Neuromodulation Society through their website member portal. The database contains information on existing and emerging products in a number of product categories, including spinal cord stimulation, deep brain stimulation, leads, power supplies, and many others. Users can search by product category, company name, or medical condition. The database reports details such as approval status, reimbursement, and product description. (Neurotech Reports)

New U.S. Patents Announced by Sacral Neuromodulation Device Maker

Dec. 4, 2017 - Axonics Modulation Technologies, Inc. announced seven new U.S. patents for its sacral neuromodulation system, adding to its more than 100 granted, and 80 pending, patent applications in various worldwide jurisdictions. (Business Wire)

Company Announces Singapore Approvals for Non-Invasive Device

Dec. 4, 2017 - Soterix Medical, Inc. announced it has received approval by Singapore’s Health Sciences Authority (HSA) for its non-invasive transcranial direct current stimulation (tDCS) device for fibromyalgia-related migraines and other chronic pain. It also announced HSA approval for its tDCS device for symptoms associated with major depression. Their office-based therapist entail using a cap to position the electrodes. (Fibromyalgia News Today)

Responsive Neurostimulation Company Combines Device Data Management and Programming in One Tablet

Dec. 1, 2017 - NeuroPace, Inc. has launched a tablet that, in one interface, integrates its online patient data management system and the programmer for its responsive neurostimulation system. The company's responsive neurostimulation system was approved by the FDA in 2013 as adjunctive therapy in adults with certain types of epilepsy that have not responded to two or more medications. (MPR)

CE Mark Announced for Spinal Cord Stimulation System

Nov. 30, 2017 - Nevro Corp. announced it received CE mark approval for its next-generation spinal cord stimulation system, permitting its sale in European Economic Area countries. (PR Newswire)

Device Company Raises $70 Million in Series B Financing Round

Nov. 29, 2017 - The company electroCore said it completed a Series B round of financing and raised slightly more than $70 million. The proceeds will be used for the commercial launch and potential expansion of its gammaCore therapy for primary headache, as well as continued development of its noninvasive vagus nerve stimulation therapy. (Markets insider)

Neurostimulator Anchor Receives Clearance from the FDA

Nov. 28, 2017 - Stimwave LLC announced receiving FDA clearance for its pain-relief neurostimulator anchor systems. They are deployed through a needle puncture used to implant the neurostimulator leads. (Business Wire)

Company's Neurostimulator Receives CE Mark for MRI-Conditional Body Scans

Nov. 16, 2017 - Nevro Corp. announced receiving CE mark approval for MRI conditional use of its high-frequency spinal cord stimulator for chronic pain. Previously the device had CE mark for head and extremity MRI scans. The new approval applies retroactively to patients already implanted with the device. (Mass Device)

Startup Focuses on Advancing Neuroprosthetic Capabilities

Nov. 16, 2017 - An article describes the efforts of the startup Kernel to develop ambitious neuroprosthetic capabilities to sense and stimulate through brain-computer interfaces. (Wired)

FDA Approves Percutaneous Nerve Field Stimulation Device for Opioid Addiction Withdrawal Treatment

Nov. 15, 2017 - A noninvasive percutaneous nerve field device worn behind the ear and previously cleared by the U.S. FDA for acupuncture indications in 2014 has received approval for use by prescription to treat acute symptoms of opioid withdrawal. The treatment is intended to be a transitional aid for medically assisted weaning from opioid addiction. The electro auricular device was studied in 73 patients, who reported a 31% reduction in such symptoms as sweating, gastrointestinal upset, agitation, insomnia and joint pain after 30 minutes of stimulation. In a news release, the device developer, Innovative Health Solutions, Inc., said withdrawal symptoms were reduced by 84.6% in at least 60 minutes of treatment with the single-use device. The company posted a brief video explaining the function of their NSS-2 Bridge device. (MD Magazine)

Noninvasive Brain Stimulation System Receives FDA Clearance for Depression Treatment

Nov. 13, 2017 - The FDA has cleared Nexstim plc's noninvasive, navigated transcranial magnetic stimulation system for the treatment of major depressive disorder, the company announced. (Fierce Medical Devices)

In Small Study, Optic Nerve Electrical Stimulation Stopped or Reversed Glaucoma in Most Patients

Nov. 13, 2017 - A yearlong study in Germany of 13 patients with glaucoma, presented at the Deutsche Ophthalmologische Gesellschaft Congress in Berlin, found that electrical stimulation of the optic nerve cells aided 75% of patients by stopping profession of the disease or improving vision, according to the device maker, EBS Technologies. (PR Newswire)

Noninvasive Neurostimulation Startup Featured in Article About Combating the Opioid Epidemic

Nov. 9, 2017 - An article about small businesses that address the opioid epidemic describes a noninvasive neurostimulation therapy for phantom pain that the startup SPR Therapeutics, Inc. offers. (Inc.)

Company Says Study Shows Noninvasive Stimulation Improved Balance in Head-Injury Patients

Nov. 9, 2017 - Helius Medical Technologies, Inc. said a double-blind, randomized, sham-controlled clinical study of its cranial nerve noninvasive neuromodulation system to improve balance in 122 subjects with mild to moderate traumatic brain injury showed improvements from baseline that averaged more than three times the clinically significant amount. The company plans to file for device clearance from the FDA in 2018. (Nasdaq)

FDA Reportedly Fast-Tracks Review of a Visual Prosthetic

Nov. 8, 2017 - Second Sight Medical announced the FDA gave its next-generation visual prosthesis a expedited review pathway. This device bypasses the optic nerve by using a cortical implant connected to a camera. (Mass Device)

Lifetime Analysis of Transcranial Magnetic Stimulation for Depression Finds It Cost-Effective After One Medication Failure

Oct. 26, 2017 - An analysis concludes that repetitive transcranial magnetic stimulation provides lower costs with better outcomes, with direct costs and quality adjusted life years ranging from $2,952/0.32 to $11,140/0.43 for younger patients. The authors say their results support the use of the therapy after a single failed antidepressant medication trial. (PLoS ONE)

Company Plans a Pivotal Trial of Its Sacral Neuromodulation System

Nov. 7, 2017 - Axonics Modulation Technologies Inc. announced it has received an investigational device exemption from the U.S. FDA and plans to begin patient enrollment in November in a pivotal clinical trial of its sacral neuromodulation system for urinary urgency incontinence. The company anticipates enrolling about 120 patients in the single-arm, prospective study at 15 centers in the U.S. and Western Europe. (Medical Device News Magazine)

CE Mark Announced for Neurostimulation System

Nov. 6, 2017 - Medtronic pls announced it received CE marking for its spinal cord stimulator that is managed through a tablet interface. The designation applies to both spinal cord stimulation and peripheral nerve stimulation, the company said. (Globe Newswire)

National Institutes of Health Seeks Clinician, Industry Input on Studies of Peripheral or Spinal Cord Neuromodulation of Organ Function

Nov. 2, 2017 - The National Institutes of Health program SPARC (Stimulating Peripheral Activity to Relieve Conditions) seeks input from clinicians and industry, through two requests for information, by Dec. 1st, regarding potential ways to improve the therapeutic potential and scientific impact of studies of peripheral or spinal cord stimulation to modulate organ function. Clinician perspectives are needed on topics such as surgical planning and access tools, device design and functionality, and the potential collection of physiology data for research in clinical settings. Clinician input may be submitted via the request for information NOT-RM-17-023. Input from industry scientists and engineers is sought on ways to establish effective public-private partnerships around clinical studies, to pursue new therapeutic opportunities using existing technology, and to explore the use of devices with expanded research capabilities to maximize data yield from clinical device-based studies. Industry perspectives may be submitted via the request NOT-RM-17-015.

As explained in the requests, responses can be submitted via email [email protected], through teleconference meetings with the SPARC team requested at, or through voicemail messages left at the provided telephone number. Responses must be submitted by Dec. 1, 2017

Device Company Presents Clinical Trial Results in Pediatric Attention Deficit Hyperactivity Disorder

Oct. 30, 2017 - NeuroSigma, Inc. presented results of its double-blind randomized controlled clinical trial of external trigeminal nerve stimulation for attention deficit hyperactivity disorder in children aged 8 - 12. Of the 62 subjects in the study, those who were randomized to active treatment showed statistically significant symptom improvement after nightly treatment for four weeks, according to data presented at the annual meeting of the American Academy of Child and Adolescent Psychiatry. (Markets Insider)

Company Develops Non-Invasive Brain Stimulation System it Hopes Will Address Depression

Oct. 23, 2017 - Flow Neuroscience developed a wearable device for stimulating the left frontal lobe to address depression. The device is accompanied by a mobile app that provides reminders about sleep and activities. The company, a startup in Malmö, Sweden, developed it through the technology accelerator HAX, and plans to initially target Nordic markets, and those in the UK and Germany, if it receives licensing approval from European authorities. (Nordic Business Insider)

Responsive Neurostimulation Company Raises $74 Million

Oct. 24, 2017 - NeuroPace, Inc. announced it has closed a $74 million financing round to expand marketing of its responsive neurostimulation system to treat epilepsy. The investors commented about the potential to apply the technology to other conditions. (Fierce Biotech)

Company Rebrands As Its Portfolio Expands to Address Obesity-Related Conditions

Oct. 23, 2017 - EnteroMedics, Inc. is following its acquisition of ReShape Medical, Inc. with rebranding itself with the name ReShape Lifesciences, updating its NASDAQ ticker to RSLS. (Mass Device)

French Authorities Permit Pilot Study of Visual Prosthesis

Oct. 19, 2017 - Pixium Vision announced approval from the French regulatory agency to recruit five patients for a feasibility study of the company's next-generation retinal implant. The three-year study will explore tolerance of the system and its evoked central vision perception in people with dry age-related macular degeneration. (Mass Device)

Company Receives Grant for Asthma Treatment

Oct. 19, 2017 - Nexeon MedSystems Inc. received a Phase I Small Business Research Innovation grant from the U.S. National Heart, Lung, and Blood Institute to develop a neurostimulation therapy for asthma with Oregon Health Sciences University. The vagus nerve stimulation treatment would be a second-line defense to open airways. (PR Web)

Device Company Raises $61 Million

Oct. 18, 2017 - EnteroMedics, Inc. raised $61 million in a new round of equity financing. The fundraising followed an announcement that the company will pay about $38 million to acquire ReShape Medical, which developed a balloon device for weight loss. (Mass Device)

Newly Approved Study in Germany Will Test Retinal Prosthetic in Better-Sighted Patients

Oct. 17, 2017 - Second Sight Medical said it received approval in Germany to study its retinal prosthetic in 10 better-sighted individuals who have retinitis pigmentosa and tunnel vision. The device is supposed to improve the visual field, to enhance functional vision. (Mass Device)

Neurostimulator Sales Launched in the United States of Wirelessly Controlled Device Addressing Complex Regional Pain Syndrome

Oct. 16, 2017 - Abbott launched U.S. sales of a Bluetooth-enabled dorsal root ganglion stimulation system designed to treat complex regional pain syndrome of the lower limbs. (Mass Device)

Trade Publication Column Highlights an Interview with a Neurostimulation Company CEO

Oct. 9, 2017 - An editor speaks to Maria Bennett, founder and CEO of SPR Therapeutics, about the company's transition from R&D to a commercial focus now its peripheral nerve stimulator has received FDA clearance. In addition, she pointed to the challenge of health insurance reimbursement. The column also discusses recognition of the need for better pain management options in light of the opioid crisis. (Med Device Online)

Company Developing Directional Leads for Deep Brain Stimulation Raises Capital

Oct. 4, 2017 - Aleva Neurotherapeutics, which was spun out of the Swiss Federal Institute of Technology in Lausanne (EPFL), and is developing directional leads for deep brain stimulation, raised $13 million in a Series D financing round. The proceeds are expected to be applied toward seeking CE mark approval. (Startup Ticker)

FDA Approves Vagus Nerve Stimulation System for Drug-Resistant Epilepsy

Oct. 9, 2017 - LivaNova PLC announced FDA approval for a vagus nerve stimulation system for adjunctive therapy in patients aged four years old or older who have drug-resistant epilepsy. The operation includes a detect-and-respond mode. (Business Wire)

Neurostimulator Receives FDA Approval for Central Sleep Apnea

Oct. 6, 2017 - The FDA approved an implant for moderate to severe central sleep apnea that stimulates the phrenic nerve through a vein. The system has been developed by Respicardia, Inc. (FDA)

Company Says Autonomic Nervous System Stimulation Lowered Autoimmune Disease Symptoms in Pilot Trial

Oct. 4, 2017 - The bioelectronics company Thync Global Inc. announced results of a single-blind study of its non-invasive device that stimulates the autonomic nervous system. The device is worn on the neck. In the 28-person study, the company said that symptoms of plaque psoriasis decreased by at least 50% in 15 of 18 people who used the device daily for four weeks. By contrast, only 2 of 10 people in the control group saw their symptoms lowered by at least 50%. (Mass Device)

Article Describes Peripheral Nerve Stimulation as an Alternative to Opioids or Surgery for Pain Relief

Oct. 2, 2017 - An article presents a percutaneous peripheral nerve stimulation device by SPR Therapeutics as a therapy meant to help control pain without the risks or side effects of opiates or invasive surgery. (R&D Magazine)

Neurostimulation Device Developer Announces Its Over-the-Counter Trading

Sept. 29, 2017 - The neurostimulation company Nexeon MedSystems, which is developing a deep brain stimulation system, has begun "regular way" trading on the OTC Market (OTC:QB) as NXNN. (BioSpace)

FDA Clears Non-Invasive Stimulation System for Use During Migraine

Sept. 21, 2017 - Cefaly Technology announced the FDA has cleared its external trigeminal nerve stimulator for use during a migraine attack. It had been previously cleared for use to prevent an attack. (MPR)

FDA Approves Spinal Cord Stimulator

Sept. 18, 2017 - Medtronic plc has received FDA approval for a rechargeable spinal cord stimulation system that can be controlled by a tablet device. An article about the development discusses neurostimulation as an alternative to addictive opioid drugs. (Star Tribune)

Development Agreement is Extended for Non-Invasive Neuromodulation Device

Sept. 13, 2017 - Helius Medical Technologies, Inc. announced its wholly owned subsidiary NeuroHabilitation Corporation extended a development agreement with the U.S. Army Medical Research and Materiel Command through 2018, and extended the deadline for commercialization of the Portable Neuromodulation Stimulator device to Dec. 31, 2021. Helius anticipates FDA clearance of the non-invasive device in 2018. The device is initially being developed to treat chronic balance disorder in patients with mild to moderate traumatic brain injury. (Globe Newswire)

Peripheral Nerve Stimulation Device Company Raises $25 Million

Sept. 12, 2017 - SPR Therapeutics, Inc. completed a $25 million Series C financing round. The investment will support commercialization of its peripheral nerve stimulation system and research into other indications, including acute post-surgical pain and chronic low back pain. (Markets Insider)

Results Presented in Clinical Trail of Non-Invasive Vagus Nerve Stimulation for Acute Migraine Treatment

Sept. 11, 2017 - The medical device company electroCore announced results at the 18th Congress of the International Headache Society of its double-blind, randomized, sham-controlled trial of non-invasive vagus nerve stimulation for the acute treatment of episodic migraine. The multicenter study enrolled 243 patients. Data presented in the late-breaking oral presentation showed the intervention was superior to sham for pain freedom at 30 and 60 minutes after the first treated migraine attack. (Markets Insider)

Privately Held Spinal Cord Stimulation Company Receives Investment from Australian Fund

Sept. 11, 2017 - The Australian life sciences investment firm BioScience Managers invested $3.3 million in the neuromodulation device company Saluda Medical. The investment is part of a $53 million funding round. Proceeds will help fund a randomized, double-blind clinical trial in 11 U.S. sites of the company's spinal cord stimulation system. (BioSpace)

Maker of Non-Invasive Vagus Nerve Stimulation System Raises $36 Million, Seeks and Additional $29 Million

Sept. 8, 2017 - Vagus nerve stimulation device company electroCore has raised $36 million in a round of equity and options financing, with the intent to raise $29 million more for a total of $65 million. In July, the company launched an FDA-approved non-invasive vagus nerve stimulation system to address pain of episodic cluster headache in adults. (Mass Device)

Company Developing Neurostimulation for Inflammatory Disease Raises $30 Million in a New Funding Round

Aug. 28, 2017 - SetPoint Medical, which is developing bioelectronic medicine for chronic inflammatory disease, raised $30 million in Series D financing from existing investors. An article notes the investors include Medtronic and Boston Scientific Corp. (Mass Device)

Pain-Device Company Approaching Commercial Stage Names New President and CEO

Aug. 28, 2017 - Neuros Medical Inc.'s founder Jon Snyder will become chief business officer as Tom Wilder, who has been an executive of neurovascular companies, becomes president and CEO. The company will open an operational center in the San Francisco Bay Area. The company is completing a pivotal clinical trial of its neurostimulation device in patients with post-amputation pain. (Trains Cleveland Business)

Visual Prosthesis Company Announces Conditional Approval of Clinical Study

Aug. 28, 2017 - Second Sight Medical Products said it received conditional FDA approval to start a human feasibility clinical study of its cortical visual prosthesis system. Up to five patients would be enrolled. (Healio)

Article: Device Company May Seek Additional Investment as Clinical Trial Nears Completion

Aug. 24, 2017 - Mainstay Medical anticipates seeking expanded funding as the company completes its U.S. clinical trial of its implant for chronic disabling back pain. The clinical trial is reported to be expected to be completed by the end of 2017. (Irish Times)

Company Raises $18 Million in Public Offering

Aug. 17, 2017 - EnteroMedics, Inc. raised $18.1 million in a recent public preferred stock offering. (Mass Device)

Company Raises Funds to Study Low-Energy Transcranial Magnetic Stimulation for Treatment-Resistant Depression

Aug. 11, 2017 - NeoSync, Inc. has closed a $23 million Series D round of funding to finance a trial of its transcranial magnetic stimulation technology in treatment-resistant depression. The company's home-use device delivers low-energy, alternating magnetic field stimulation. (Fierce Biotech)

Device Company Plans Public Offering

Aug. 11, 2017 - EnteroMedics, Inc. has priced a preferred stock offering of $20 million that is expected to close Aug. 16, to support commercialization and product development. (Mass Device)

Neurostimulator Receives Conditional MRI Clearance in the U.S.

Aug. 9, 2017 - Stimwave LLC announced its peripheral neurostimulation pain-relief device has received FDA 510(k) clearance for full-body MRI scans under certain conditions. (Business Wire)

Neuromodulation Company Closes $20 Million Round of Venture Financing

Aug. 7, 2017 - Neuros Medical, Inc. announced it raised $20 million to help fund a pivotal trial of its peripheral nerve stimulator for post-amputation pain. The company anticipates enrolling up to 130 individuals at 15 institutions. (Fierce Biotech)

FDA Provides Clearance for TENS Device With Novel Waveform

Aug. 2, 2017 - A South African company, Xavant Technology, received FDA clearance to sell a transcutaneous electrical nerve stimulation (TENS) system in the U.S. for pain relief. The company said its device combines a monophonic square wave with a patented hybrid pulsed radio frequency waveform. (Fierce Biotech)

Vagus Nerve Stimulation Systems Receive CE Mark for Expanded MRI Labeling

Aug. 1, 2017 - LivaNova PLC announced its latest vagus nerve stimulation systems, for adjunctive treatment of medication-resistant epilepsy, have received CE Mark for expanded MRI labeling. The systems received similar expanded labeling approval a month ago from the FDA. (Business Wire)

Deal Calls for Modified Vagus Nerve Stimulation System for Preclinical Research

July 26, 2017 - EnteroMedics, Inc. entered a collaboration agreement with Galvani Bioelectronics Limited to modify its vagus nerve stimulation implant for use in preclinical research by Galvani. In the agreement, EnteroMedics will receive development payments and retain rights to the new device, licensing it to Galvani. The abdominal implant was FDA approved in 2015 for addressing obesity by limiting feelings of hunger. (Fierce Biotech)

Company Launches U.S. Sales and Registry of Non-invasive Vagus Nerve Stimulator for Episodic Cluster Headache

July 18, 2017 - A hand-held vagus nerve stimulation device is being launched in the U.S. for acute treatment of pain from episodic cluster headaches in adults by the device company electroCore, following FDA approval in April. The company is also launching a device registry to gather patient experience and self-reported quality-of-life information. (PR Newswire)

Sacral Neuromodulation Device Company Raises $20.5 Million

July 6, 2017 - Axonics Modulation Technologies, Inc. announced it raised an additional $20.5 million in a second closing of its Series C financing, bringing the total raised in this series to $35 million. The proceeds will be used to fund a pivotal study in the U.S. of its rechargeable sacral neuromodulation system in overactive bladder. (Business Wire)

Neuromodulation Device Outsourcing Company to Receive an Investment of About $136 Million

July 5, 2017 - The investment firm 3i Group plc announced it will provide about $136 million to Cirtec Medical, a provider of outsourced design, development, and manufacture of neuromodulation devices and other medical devices. (PE Hub)

Neurostimulator Company Announces First Implants of Its Wireless Devices for Chronic Pain in Brazil

July 5, 2017 - Stimwave LLC announced plans for the first chronic pain patients in Brazil to receive implants of the company's wireless neurostimulators. (Business Wire)

Bioelectronics Company That is Targeting Migraine Treatment Raises $6 Million

July 4, 2017 - Israel-based medical device company Theranica Bio-electronics raised $6 million in Series A financing, which it will use on the regulatory process for its first product, an acute treatment for migraine. The company said its device is in a pivotal study in eight hospitals and clinics in the U.S. and Israel. The company was founded in 2016 to develop wireless neuromodulation approaches. (Globes)

More States Will Provide Medicaid Reimbursement for Retinal Prosthesis

July 3, 2017 - Second Sight Medical said its retinal prosthesis has received expanded reimbursement coverage from the Centers for Medicare and Medicaid Services in 11 states (beyond the previous 17) and the District of Columbia. (Mass Device)

FDA Approves Implanted Vagus Nerve Stimulation System for Epilepsy Patients as Young as 4 Years Old

June 30, 2017 - LivaNova announced its implanted vagus nerve stimulation system received FDA approval for adjunctive treatment in patients aged 4 and older who have medically refractory partial-onset seizures. Previously, the device was approved for patients aged 12 and older. Earlier in June, the company announced its device had received expanded MRI labeling from the FDA. (Medscape)

Vagus Nerve Stimulation in Stroke Rehabilitation: Pilot Data Presented, Pivotal Clinical Trial Announced

May 31, 2017 - At the International Neuromodulation Society 13th World Congress, results of a randomized controlled pilot study were presented regarding 20 patients undergoing physical rehabilitation for stroke. Nine of the 20 patients received six weeks of vagus nerve stimulation in conjunction with intensive physical rehabilitation. The combination led to improvement in 75% of patients, compared to improvement in 33% of the 11 patients who only received physical rehabilitation. The response to the combined intervention increased to 88% at 90 days, and scores continued to increase through 9 months. At the same meeting, MicroTransponder, Inc. announced a 120-patient pivotal clinical trial of this intervention will begin enrollment this summer in the U.S. and U.K. (

Startup Plans Clinical Trial of Contact Lenses for Glaucoma

May 31, 2017 - Bionode, a Purdue University affiliated startup, plans to start a clinical trial of a contact lens designed to decrease pressure within the eye to treat glaucoma. The device includes a gold loop that receives an electromagnetic field from a special pair of glasses, which is converted into a current and delivered to a part of the eye that helps drain fluid build-up. (Journal & Courier)

Company Announces Positive Interim Results of Rechargeable Neurostimulator for Overactive Bladder

May 30, 2017 - Axonics Modulation Technologies, Inc. announced interim results of a prospective multi-center clinical study of its rechargeable sacral neuromodulation system for the treatment of overactive bladder. Of 33 patients who reached the three-month mark, 71% experienced at least a 50% decrease in symptoms, according to the results presented at the International Neuromodulation Society 13th World Congress. (Business Wire)

Company Announces $40 Million Pre-Commercial Investment

May 29, 2017 - Saluda Medical Pty Limited announced it received $40 million in a series D round of financing led by new investor Action Potential Venture Capital, a GSK fund, with previous investors participating. The funding should support clinical development of an intelligent, closed-loop spinal cord stimulation system that is undergoing a prospective, randomized, controlled, double-blinded clinical study by pain specialists at up to 20 U.S. sites. The funding will also allow the company to commercialize the therapy in Europe and Australia. (PR Newswire)

Company Announces CE Marking for Peripheral Nerve Stimulation Anchoring System

May 26, 2017 - Freedom Neuro BV, a medical device distributor for Stimwave Technologies, announced CE mark approval for a percutaneous injectable anchor system used with Stimwave's neurostimulation devices designed to address chronic pain. (Business Wire)

Company Announces Financing for Clinical Validation of Its Stretchable Neuromodulation Lead

May 25, 2017 - WISE Srl announced EUR 6.5 million in series B financing to clinically validate its flexible, stretchable implantable neuromodulation leads for brain monitoring and spinal cord stimulation. Based on Italy with an office in Berlin, the company opened a production plant in Milan in 2016, where the leads' electrode functionality is impregnated into a polymer substrate using supersonic cluster beam implantation. (Gruenderfonds)

Company Receives $6 Million to Develop Peripheral Nerve Stimulation for Pain Relief

May 15, 2017 - SPR Therapeutics has received a second contract from the U.S. Department of Defense to use its peripheral nerve stimulation system for relief of chronic pain. Including an previous grant, the company has received nearly $9 million for research and commercialization of the therapy. (P&T Community)

Company Announces Its Neurostimulator's First Use in Ireland

May 9, 2017 - Mainstay Medical International plc announces its first sale and implant of its neurostimulation system to treat disabling chronic low back pain in Ireland. (Business Wire)

Sacral Neuromodulation Device Maker Raises $14.5 Million

May 2, 2017 - Axonics Modulation Technologies has raised $14.5 million toward its goal of $30 million for a series C round of financing for a pivotal study of its rechargeable sacral nerve stimulation system in overactive bladder. The clinical trial is anticipated to start in the second half of 2017 at medical centers in the U.S. and Europe. (Fierce Biotech)

Company Plans Clinical Study of Neurostimulator for Weight Loss

May 2, 2017 - According to an SEC filing, EnteroMedics Inc. will fund a clinical study of its vagus nerve stimulation implant by the Southern California Permanente Medical Group, to investigate the device as an aid for weight loss in patients who have Type 2 diabetes and obesity. (Mass Device)

International Neuromodulation Society Innovations Day Will Present 12 Emerging Companies and Organizations

April 27, 2017 - Twelve emerging companies and organizations will present their innovative therapeutic strategies at the International Neuromodulation Society's Innovations Day preconference on May 28, 2017 in Edinburgh. They are endeavoring to address such conditions as paralysis, autism, and challenging persistent pain. (International Neuromodulation Society)

FDA Approves Neurostimulator to Treat Dry Eye

April 25, 2017 - The FDA granted marketing authorization to Allergen plc for its stimulator to temporarily increase tear production in adults with dry eye. The handheld device is designed for intranasal use with disposable tips. (PR Newswire)

Company Receives a Five-Year Contract to Supply its Wireless Neurostimulation System to the U.S. Department of the Defense

April 21, 2017 - Stimwave Technologies announced it received a five-year contract from the Department of Defense to supply its spinal cord stimulation system. (Mass Device)

Portable, Hand-Held Device Receives FDA Approval to Treat Cluster Headache

April 18, 2017 - The FDA has approved a non-invasive vagus nerve stimulation device to treat episodic cluster headaches. The manufacturer, electroCore LLC, said the condition affects about 350,000 people in the U.S. (NBC)

Company Will Present Results of Clinical Trial of Rechargeable Sacral Neuromodulation in Overactive Bladder

April 18, 2017 - Axonics Modulation Technologies, Inc. will present initial results of its  prospective, multicenter clinical study of its rechargeable sacral neuromodulation system in 51 patients with overactive bladder at the International Neuromodulation Society 13th World Congress on May 30, 2017. (Yahoo Finance)

Company Announces Brazilian Approval for Its Non-Invasive Brain Stimulation Products

April 13, 2017 - Soterix Medical said it has received regulatory approval in Brazil for its transcranial direct current stimulation products intended to address pain or depression. (P&T Community)

Company Announces FDA Approval for its Transcranial Magnetic Stimulation Device

April 12, 2017 - NeuroStar announced it has received FDA clearance for its most recent transcranial magnetic stimulation device, which provides treatment in 19 minutes, for use in major depressive disorder. (Mass Device)

FDA Nominee at Hearing: Devices May Aid Fight Against Opioid Crisis

April 6, 2017 - The nominee for FDA commissioner said at his confirmation hearing that a partial solution for the opioid abuse epidemic may be found in alternatives that include devices for pain control and drug-delivery devices. (Medtech Insight)

Company Launches Neurostimulator in Australia

April 7, 2017 - Stimwave LLC has received regulatory approval from the Australian Therapeutic Goods Administration for its wireless spinal cord stimulation system. The company launched the product at the 12th annual meeting of the Neuromodulation Society of Australia and New Zealand. (Business Wire)

Australian Company Raises $18 Million for Clinical Trial of Visual Prosthesis

April 5, 2017 - Bionic Vision Technologies of Melbourne, Australia has raised $18 million for clinical trials of its retinal implant to treat retinitis pigmentosa. (Med Device Online)

Enrollment Begins in Clinical Trial of Neurostimulator for Chronic Head and Face Nerve Pain

April 3, 2017 - StimRelieve LLC announced it has enrolled the first of approximately 50 patients in its clinical trial of a neurostimulator to treat chronic craniofacial nerve pain. (Yahoo Finance)

Startups Explore Possible Creation of Neural Tools

March 31, 2017 - An article describes two entrepreneurs' investments in "neural tools" startups to create new hardware and software. (Wired)

Company Reports Insurance Coverage for Peripheral Nerve Stimulation System

March 27, 2017 - Bioness, Inc. reported that its peripheral nerve stimulator received insurance coverage from Aetna, Inc. to treat chronic pain of peripheral nerve origin. (Yahoo Finance)

Device Company That is Focused on Chronic Low Back Pain Releases 2016 Annual Report

March 23, 2017 - Mainstay Medical International plc announced publication of its 2016 annual report. The company received CE mark approval for its neurostimulator for chronic low back pain in 2016 and initiated commercial sales in Germany earlier in 2017. In preparation for filing for pre-market approval in the U.S., the company has selected 27 clinical trial sites, where 18 are already enrolling patients. Enrollment completion is anticipated by the end of 2017 with data expected to be available in 2018. (Business Wire)

Venture Capital Firm Invests in Early Stage Neuromodulation Company

March 20, 2017 - SetPoint Medical announced it has received an investment from the venture capital firm New Enterprise Associates (NEA), and NEA general partner Dr. Josh Makower has joined its board of directors. (Mass Device)

Retinal Prosthesis Maker Raises About $20 Million

March 9, 2017 - Second Sight Medical closed a rights offering that raised approximately $20 million to support continued development and improvement of its retinal prosthesis. (Mass Device)

Bioelectronics Research Institute Enters Partnership to Address Cardiovascular Issues

March 9, 2017 - The Feinstein Institute for Medical Research entered a partnership with United Therapeutics Corp. to apply bioelectronics and cell-therapy technologies to cardiology and hypertension cases. (Innovate)

Neurostimulator Company Receives Expanded CE Mark for Disabling Migraine

March 9, 2017 - Autonomic Technologies, Inc. announced it received an expanded CE mark indication for its sphenopalatine ganglion stimulator for patients with highly disabling migraine. (PR Newswire)

Company Announces U.S. Patents for Its Sacral Neuromodulation System

Feb. 23, 2017 - Axionics Modulation Technologies, Inc. announced issuance of four U.S. patents related to the company's implantable sacral nerve stimulation technology. (Yahoo Finance)

Company Announces First European Implants of Its Neurostimulator for Peripheral Neuralgias

Feb. 22, 2017 - Bioness, Inc. announced a series of the first implantations of its percutaneous peripheral nerve stimulation system at medical centers in the Netherlands, Ireland, and Belgium. (Yahoo Finance)

Company Developing a Non-invasive Neurostimulator Raises Nearly $10 million

Feb. 16, 2017 - Helius Medical Technologies raised nearly $10 million in a public offering. The company plans to complete a clinical trial of its portable neurostimulator in treating mild to moderate traumatic brain injury. In addition, the company plans new clinical trials in multiple sclerosis and cognition, and to submit an FDA application. (Mass Device)

Startup Would Use Ultrasound to Non-Invasively Stimulate Vagus Nerve

Feb. 11, 2017 - A doctor and an engineer have begun investigating non-invasive stimulation of the vagus nerve through their startup company, Acuta Technologies. An article describes their interest in applying the technology to potentially address diabetes, or control appetite or inflammation. (Minneapolis Star Tribune)

Company Developing Non-Invasive Stimulator Plans Public Offering

Feb. 10, 2017 - Helius Medical Technologies plans a public offering on the Toronto Stock Exchange that could bring in about Can$10.8 million. The company also announced publication of a pilot study of its non-invasive stimulator in patients with multiple sclerosis. (Seeking Alpha)

Marketing Clearance Received for Device to Improve Gait

Feb. 8, 2017 - A Bioness system that provides stimulation to assist with gait received FDA clearance. The system includes feedback and a learning algorithm to correct gait as a patient moves. (FDA News)

Company Seeks Regulatory Approval for Sacral Nerve Stimulation System

Feb. 1, 2017 - Nuvectra Corporation filed regulatory submissions with the FDA and CE mark authorities for its sacral nerve stimulation system to treat chronic urinary retention or overactive bladder symptoms. (Nasdaq)

Germany's First Patient Receives First Implant for Disabling Chronic Low Back Pain

Jan. 31, 2017 - Mainstay Medical International plc announced the first sale and implant of its neurostimulation system for disabling chronic low back pain in Germany. (Business Wire)

Company Prepares to Test Non-invasive Neuromodulation Device in Neuromotor Spasticity

Jan. 23, 2017 - PathMaker Neurosystems Inc. announced it will start a clinical trial in Paris of a non-invasive neuromodulation device to treat neuromotor spasticity. (Business Wire)

Device Company Targeting Weight Loss Raises $19 Million

Jan. 19, 2017 - The company EnteroMedics Inc. announced it raised $19 million in an oversubscribed public offering. The company is commercializing a vagus nerve stimulation system for weight loss. (Mass Device)

Company Seeks to Market Neurostimulation Device for Pain in Australia

Jan. 12, 2017 - Mainstay Medical has applied to sell its neurostimulation system for back pain in Australia, requesting for the device to be added to the Australian Register of Therapeutic Goods. (Irish Times)

Health Canada Approves a Rechargeable Sacral Neuromodulation System

Jan. 5, 2017 - Axonics Modulation Technologies, Inc. announced it received medical device approval  from Health Canada for its rechargeable sacral neuromodulation system to treat overactive bladder, fecal incontinence and urinary retention. (Yahoo Finance)

Visual Prosthesis Receives Reimbursement Approvals

Dec. 22, 2016 - Second Sight Medical announced the U.K. National Health Service said “a selective group of severely blind patients with Retinits Pigementosa can have access" to the company's retinal prostheses system through two implantation centers, the Manchester Royal Eye Hospital and London’s Moorfields Eye Hospital. In November the company received reimbursement codes from the U.S. Centers for Medicare & Medicaid Services. (Mass Device)

U.S. Air Force and Company Parter to Study Non-invasive Neuromodulation to Augment Cognitive Performance

Dec. 20, 2016 - Rio Grande Neurosciences of Albuquerque and the U.S. Air Force 711th Human Performance Wing have reached a cooperative research and development agreement to develop and evaluate neuromodulation through testing on 36 recruited participants non-invasive stimulation approaches involving pulsed electromagnetic field stimulation, transcranial direct current stimulation paradigms, and transcranial alternating current stimulation. A technology transfer announcement said, "If shown to be effective in this project, these technologies and techniques may provide a new treatment for medical patients, as well as a simple and cost-effective method for sustaining airmen performance in critical Air Force jobs such as image analysts, cyber operators, and remotely piloted aircraft operators." (U.S. Air Force)

Sacral Neuromodulation System is Being Evaluated in Fecal Incontinence

Dec. 6, 2016 - Axonics Modulation Technologies, Inc. said two patients in the U.K. have been implanted with its rechargeable sacral nerve stimulation system as part of a 12-patient evaluation of the system in the treatment of fecal incontinence. The system received CE mark approval in June 2016, and to date more than 25 patients in the Netherlands, Belgium, France and the U.K. have been implanted as part of a post-market clinical follow-up study in overactive bladder. (Business Wire)

First Patient is Enrolled in Study of an Implanted Tibial Nerve Stimulator

Dec. 15, 2016 - Stimguard LLC announced it has enrolled its first patient with overactive bladder in a study of chronic, nightly, tibial nerve stimulation therapy. The randomized, comparative study will enroll up to 242 patients. In it, weekly office-based stimulation will be compared to the company's device that uses an external transmitter to power a small implanted stimulator at night. (Yahoo Finance)

Spinal Cord Stimulation System Receives CE Mark Approval for Conditional Full-Body Magnetic Resonance Imaging

Dec. 8, 2016 - St. Jude Medical, Inc. has received CE mark approval for conditional labeling of a spinal cord stimulation system for full-body magnetic resonance imaging. (BusinessWire)

Company to Enroll Alzheimer's Patients in Clinical Trial of Non-Invasive Brain Stimulation Device

Dec. 6, 2016 - NeuroEM Therapeutics, Inc. plans a clinical trial of up to 14 patients aged 65 or older who have mild to moderate Alzheimer's disease, to determine the safety and initial efficacy of transcranial electromagnetic treatment -- interdigitated electric and magnetic waves -- to improve biomarkers of the condition in functional brain imaging and testing of blood/cerebrospinal fluid. The plans for the phase 1 clinical trial follow preclinical studies showing that daily stimulation for two months with wavelengths on the order of those used for cell-phone transmissions led to lower levels of beta-amyloid plaque within and around neurons, while metabolic activity increased in diseased neurons. (PR Newswire)

Data Over Seven Years Show Seizure Rate Decline with Responsive Neurostimulation

Dec. 5, 2016 - NeuroPace, Inc. presented seven years of clinical data on 185 epilepsy patients who have used the company's closed-loop responsive neurostimulation system. The company reported a median reduction in seizure frequency of 72% in the patients, whose condition is medically refractory. The results were presented at the American Epilepsy Society meeting in Houston. (Mass Device)

Neuromodulation Start-Up Pursues a Pulse Generator Without an Application-Specific Integrated Circuit

Dec. 1, 2016 - A medical technology start-up, Lone Star Neuromodulation, says it has created a programmable, wirelessly rechargeable, 17-electrode pulse generator primarily using off-the-shelf components and no custom integrated circuits. The company adds that the device "is subject to future testing, trials and regulatory approval." (PR Newswire)

Clinical Trial to Study the Use of Vagus Nerve Stimulation in Postpartum Hemorrhage

Nov. 22, 2016 - Partners were announced in a clinical trial of vagus nerve stimulation as a potential way to halt postpartum hemorrhage. The partners are the Global Good Fund, the Feinstein Institute, and Sanguistat, Inc., which licensed the technology from the Feinstein Institute. (PR Newswire)

Company to Expand and Extend Clinical Trial of Non-Invasive Device to Treat Symptoms of Neurological Disease or Trauma

Nov. 22, 2016 - Helius Medical Technologies amended its contract with the U.S. Army Medical Research and Material Command to extend it to the end of 2017 and include additional study sites for the clinical trial of the portable neuromodulation stimulator to treat neurological symptoms caused by disease or trauma. (FDA News)

Spinal Cord Stimulation System Receives Approval for Full-Body, Conditional, MRI Scans

Nov. 14, 2016 - St. Jude Medical has received FDA approval for conditional full-body MRI using its spinal cord stimulation system that was approved in November 2015. (Fierce Biotech)

Company Demonstrates a Robotic Transcranial Magnetic Stimulation System

Nov. 14, 2016 - During the Medica 2016 trade show currently taking place in Germany, the ICube spinoff Axilum Robotics presented a robotic transcranial magnetic stimulation system intended for precision and repeatability in treatments of patients with chronic pain and other conditions. (Medical Plastics News)

Newly Public Device Company Reports Quarterly Earnings

Nov. 9, 2016 - Nuvectra Corporation announced a 196.3% increase in revenue in the third quarter of 2016, compared to the third quarter of 2015, related to a deep brain stimulation development agreement with Aleva Neurotherapeutics and commercial launch of Nuvectra's spinal cord stimulation system. The revenue of $3.8 million for the third quarter of 2016 was offset by operating expenses of $11.1 million. The company said the costs reflect its investment in a sales and marketing team and increased headcount after becoming a publicly traded company. (Globe Newswire)

Device-Maker Raises Equity Funds

Nov. 8, 2016 - An SEC filing shows that Inspire Medical Systems, which developed and produces a sleep-apnea implant, raised $12.5 million in equity financing. (Mass Device)

Company's MRI-Conditional Leads Enter Use in Canada

Nov. 8, 2016 - Medtronic Canada announced the first patients had been implanted with its spinal cord stimulation leads that are licensed for full-body MRIs under specified conditions. The announcement noted the leads have been approved by the regulatory body Health Canada. (Newswire)

First U.K. Implant Announced in a Clinical Trial of a Retinal Prosthesis

Nov. 7, 2016 - The first retinitis pigmentosa patient in the U.K. received an implanted retinal prosthesis in a clinical trial by the device company Pixium Vision. (Mass Device)

Company Announces Medicare Payment Decisions for Its Retinal Prosthesis

Nov. 2, 2016 - Second Sight Medical announced that in 2017 its retinal prosthesis will have a new Medicare implantation payment rate and billing codes for programming or reprogramming. (Mass Device)

Report Sees Growing Role for Deep Brain Stimulation

Nov. 2, 2016 - A market report predicts that by the end of the year 2021, deep brain stimulation will represent almost 20% of the market share for neurostimulation devices. (Business Wire)

First Patient Receives Visual Cortex Prosthetic Implant

Oct. 25, 2016 - Second Sight Medical announced its first patient was implanted with a visual cortical prosthesis to restore some vision to blind patients. The system will include a camera and glasses. The company hopes to win approval for an initial clinical trial of the complete system. Previously, Second Sight developed a retinal prosthesis. This later device bypasses the optic nerve entirely. (Mass Device)

Company Reports Double-Digit Growth in Neuromodulation Sales

Oct. 19, 2016 - St. Jude Medical reported in its third-quarter earnings report that neuromodulation sales increased 17% compared to the same quarter one year ago. Overall net sales were up approximately 2% compared to the third quarter of 2015. (Mass Device)

Clinical Data Presented About Vagus Nerve Stimulation in an Inflammatory Condition

Oct. 19, 2016 - SetPoint Medical presented data on eight Crohn's disease patients who had received vagus nerve stimulation implants in an open-label trial. After 16 weeks, the company said that six patients had improved so that their Crohn's Disease Activity Index dropped at least 70 points (a score higher than 450 is severe). Three of those patients also reached remission based on endoscopic findings that their bowel lining had renormalized. The investigational treatment is intended to address the body's inflammatory reflex. (Fierce Biotech)

FDA Approval for Deep Brain Stimulation System Announced

Oct. 6, 2016 - St. Jude Medical announced that its deep brain stimulation system with directional leads received FDA approval for the treatment of Parkinson's disease and essential tremor. The system received CE mark approval in September 2015 and was subsequently launched in Europe in June. (Mass Device)

Company Describes a Growing Receptiveness to Drug-Free Pain Interventions

Oct. 5, 2016 - SPR Therapeutics followed up on the July 27, 2016 announcement  of FDA approval for its peripheral nerve stimulation system for post-traumatic and post-operative pain with a announcement about neurostimulation emerging as an alternative to opioid analgesics. (Market Wired)

Company Announces FDA Approval for New Mode of Spinal Cord Stimulation

Oct. 4, 2016 - St. Jude Medical announced the FDA has approved its burst form of spinal cord stimulation for chronic pain relief. (Business Wire)

Company Plans Pivotal Trial for Implanted Anti-Hypertension Device

Oct. 3, 2016 - Valencia Technologies announced the FDA granted an Investigational Device Exemption for a clinical trial of its implanted median nerve stimulator for hypertension. The company said it plans to enroll 300 patients in a multicenter study. Patients who have been taking at least three hypertension drugs will receive six months of neurostimulation. They will be evaluated for ambulatory and clinic blood pressure. (Fierce Biotech)

FDA Clears Deep Brain Stimulation Tool

Sept. 26, 2016 - Medtronic Inc. announced the FDA has cleared its deep brain stimulation software that allows preoperative planning for deep brain stimulation surgery. The software is integrated with an intraoperative imaging system for lead placement. (Fierce Medical)

Patent Granted for a Neurostimulator Lead

Sept. 26, 2016 - Axonics Modulation Technologies, Inc. announced it has been granted a U.S. patent related its implantable neuromodulation technology for the treatment of urinary and fecal dysfunction. The patent covers a tined lead for its sacral neuromodulation system that received CE mark in June. (Business Wire)

Company Targeting Low-Back Pain Issues Half-Year Report

Sept. 22, 2017 - Mainstay Medical International plc announced publication of its half-year report for the period ended June 30, 20176. The company had $42.8 million cash on hand and operating expenses of $8.0 million. This increase reflected expansion of the team, preparation for its clinical trial of its neurostimulator for chronic low back pain, and preparation for commercial launch. The launch is being concentrated for now in Germany, where a direct sales force has been recruited and initial customers have been trained. (Business Wire)

Israeli Startup Raises Money for Its Migraine Patch

Sept. 20, 2016 - Theranica Bio-Electronics closed a round of seed financing for an undisclosed amount. The Israeli company is developing wearable electrical stimulation patches to treat migraine. (Pharmweb)

Device Company Announces European Patent for Its Vagal Nerve Stimulator

Sept. 20, 2016 - EnteroMedics Inc. announced issuance of a European patent for its implantable vagus nerve stimulation system that was developed to treat obesity and metabolic diseases. (Scibility Media)

Back Pain Neurostimulator One-Year Results Announced

Sept. 20, 2016 - Mainstay Medical International plc announced positive one-year follow-up results for 41 patients who completed 12 months in its single-arm clinical trial of a neurostimulation device for chronic low back pain. The device received CE mark in May 2016 and the clinical trial continues to enroll patients for a post-market clinical follow-up for safety and performance data. (Business Wire)

Company Plans Brain Stimulation Clinical Trial for Stroke, Announces Financing Deal

Sept. 15, 2016 - Nexstim Plc announced it is finalizing plans with the FDA for a multicenter pivotal clinical trial of repetitive transcranial magnetic stimulation following stroke. The company expects the clinical trial, which is being designed to include a sham comparator, will start in 2017. Nextstim also announced a financing agreement with Bracknor Investment to convert €20,000 of its convertible loan into 51,633 shares at €0.387345 each. (Globe Newswire)

First Patient is Enrolled for Clinical Trial of Neurostimulator for Chronic Lower Back Pain

Sept. 14, 2016 - Mainstay Medical International plc announced the first subject with chronic lower back pain has been enrolled in Australia for its clinical trial of a neurostimulator that is designed to electrically stimulate the nerves responsible for contracting muscles which stabilize the lumbar spine. (Business Wire)

Medical Device Portfolio Company with Deep Brain Stimulation Technology Files for Public Offering

Sept. 12, 2016 - Nexeon MedSystems Inc. of Lexington, KY recently filed a registration statement to become publicly traded. The company is seeking FDA approval for a rechargeable deep brain stimulation system for Parkinson's disease. (Med City News)

Peripheral Nerve Stimulator Receives CE Mark

Sept. 7, 2016 - BlueWind Medical announced its has received CE mark approval for its neurostimulator to treat peripheral neuropathic pain. The device is implanted on the tibial nerve and powered by a control unit worn on the ankle. The company said patients select stimulation for up to eight hour a day, with pain reduction typically lasting for 30 minutes to a few hours afterwards. (PR Newswire)

Company Announces Peripheral Neuralgia Treatments

Sept. 7, 2016 - Bioness, Inc. announced a series of implantations of its peripheral nerve stimulation system to treat peripheral neuralgias. The company said there is a specific focus on these areas or conditions: axillary nerve (e.g. post-stroke shoulder pain); ulnar nerve (e.g. cubital tunnel syndrome); ilioinguinal (e.g. post-surgical hernia complication); superior cluneal nerve (e.g. lower back neuralgia). (PR Newswire)

Long-Term Results Published in Prospective, Randomized Clinical Trial That Compares Spinal Cord Stimulation Therapies

Sept. 6, 2016 - Nevro Corp. announced that long-term data were published in Neurosurgery from its prospective, randomized clinical trial that compares high-frequency and traditional spinal cord stimulation in patients with chronic back and leg pain. Based on data from 156 subjects who were assessed at 24 months, secondary outcomes were reported that included the percentage of subjects who responded for leg pain, the percent of pain relief for back and leg pain, and the disability level over the follow-up period. (Street Insider)

Study: Phrenic Nerve Stimulation Improved Central Sleep Apnea

Sept. 1, 2016 - A study of 151 patients with central sleep apnea showed benefits from a transvenous phrenic nerve stimulator, according to a news release about the publication in The Lancet. The device was developed by Respicardia, Mass Device reported. (Mass Device)

Company Announces Success Among Neurostimulator's "Early Adapters"

Aug. 29, 2016 - Stimwave LLC announced it has "achieved long-term success" in the early adapter rollout of its neurostimulator to address chronic pain. The first patients were treated in 2015 for back and leg pain. In March 2016 the FDA approved uses for peripheral neuropathic pain as well. (Business Wire)

Robotic Surgical Assistant to be Exhibited at September Neurosurgical Events

Aug. 29, 2016 - Medtech announced it will exhibit its surgical assistance robot at three meetings for stereotactic neurosurgeons during September. The robot was developed for use in deep brain stimulation implantation procedures and other brain and spine surgeries. (Globe Newswire)

News Outlet Offers Overview of One Medical Device Company's Activities  

Aug. 25, 2016 - A news feature about the Alfred Mann Foundation describes its work in neurostimulation for functional restoration and other research programs. (Globes)

Drug Company's Venture Arm Sees Promise in Neuromodulation

Aug. 18, 2016 - A question-and-answer column about neuromodulation investments by the venture arm of Johnson & Johnson discusses potential indications in heart failure. In it, an executive describes the company's anticipation that neuromodulation therapies could address unmet needs in the company's areas of interest, such as "epilepsy, pain, Parkinson’s disease, sleep apnea, as well as many other chronic disease and conditions not well managed by drugs or that are drug resistant." (Med City News)

Article Says Neuromodulation is a Growth Area for Company

Aug. 18, 2016 - An article says Boston Scientific Corporation registered 12% growth in the second quarter of 2016, compared to the same quarter one year ago, which was up from its growth of about 8% in the first quarter of 2016. The article calls spinal cord stimulators a key growth area for the company's neuromodulation business, and deep brain stimulation a potential market. (Market Realist)

Peripheral Nerve Stimulation System to Be Presented at Military Health Symposium

Aug. 16, 2016 - SPR® Therapeutics planned to present recent clinical findings concerning its peripheral nerve stimulation system for acute and chronic pain control at the 2016 Military Health System Research Symposium in Florida. (Market Wired)

Company to Seek Approval for Its Device to Treat Dry Eye

July 18, 2016 - Allergan announced it is applying for FDA approval of a handheld intranasal neuromodulation device to stimulate tear production in people who have dry eye disease due to decreased tear production. (MPR)

Company Releases Second Version of Its External Neurostimulator for Episodic Migraine

July 18, 2016 - Cefaly Technology is releasing the next version of its external trigeminal nerve stimulation device for the prevention of frequent episodic migraine attacks. The Cefaly® II device is available in the U.S. and will be available next in Europe in September. (PR Newswire)

Company Eyes $21.5 Million Acquisition of Non-invasive Neurostimulation Development Firm

July 11, 2016 - Endonovo Therapeutics, Inc. announced it intends to acquire Rio Grande Neurosciences, Inc. for $21.5 million following execution of a definitive purchase agreement, shareholder approvals, and raising more capital. Privately held Rio Grande Neurosciences develops non-invasive technology for the treatment of neuro-inflammation and central nervous system diseases and disorders. The company's devices include an FDA-cleared device for treating pain and edema, a proprietary multi-coil repetitive transcranial magnetic stimulation system with pending 510(k) application, which is currently being adapted for the treatment of neuro-inflammatory conditions, including traumatic brain injury, acute concussion, post concussion syndrome and multiple sclerosis; and targeted pulsed electromagnetic field therapy for the treatment of post surgical neuroinflammation. The deal is expected to be completed by Sept. 30 and entails $15 million in Endonovo common stock, $5 million in Endonovo warrants and $1.5 million in cash. (Fierce Biotech)

Company Raises Funds for Commercialization of Sleep Apnea Neurostimulator

July 7, 2016 - Nyxoah, of Israel and Belgium, raised €18 million ($20 million) for development of its neurostimulation system for obstructive sleep apnea. Its implant is powered by a disposable patch placed on the patient's skin. (Fierce Biotech)

Neurostimulation Company to Be Tracked in a Fund Index

June 28, 2016 - The neurostimulation company Nuvectra Corporation was added June 24 to the Russell Microcap® Index. Membership in the index lasts for one year. Indexes are used for investment or benchmarking purposes by fund managers. (Nasdaq)

Developer of Noninvasive Brain Stimulation Technology Announces a Patent

June 28, 2016 - Nexstim Plc announced it received a U.S. patent for its way of estimating motor threshold when delivering transcranial magnetic stimulation to targets below the cortex. The method involves a scan of 60 - 90 seconds combined with an electromyography measurement. (Nasdaq)

Company Announces Presentation of Small Study of Neurostimulator to Augment Gait Therapy in Multiple Sclerosis

June 24, 2016 - A six-person study presented at the 2016 Annual Meeting of the Consortium of Multiple Sclerosis Centers was subject to a news release by Helius Medical Technologies. The study involved use of the company's noninvasive portable nerve stimulation system, PoNS, in combination with physical training. At the end of the trial, the company said, all patients could be considered improved, with those who had better functional status at the start making the most gains. (Mass Device)

Researchers Present Studies of Vagus Nerve Stimulation in Headache

June 24, 2016 - New Jersey-based electroCore LLC issued a news release summarizing three clinical studies and two preclinical studies regarding the mode of action of noninvasive vagus nerve stimulation in primary headache. The studies were presented at the annual meeting of the American Headache Society. (BioSpace)

Clinicians Launch Study of Rechargeable Neurostimulator for Overactive Bladder

June 20, 2016 - Axonics Modulation Technologies, Inc. announced its small, rechargeable sacral nerve stimulation system has been implanted in the first patients as part of a post-market follow-up study in overactive bladder. The study is being conducted in England, Belgium, the Netherlands and France. (Business Wire)

Concerns Raised About U.S. Insurers' Classification of High Frequency Spinal Cord Stimulation

June 20, 2016 - International Neuromodulation Society (INS) member David Provenzano, MD mentions a randomized controlled clinical trial by INS member Leonardo Kapural, MD, PhD and colleagues in remarks published in an article about letters written by the American Society of Regional Anesthesia (ASRA) to Blue Cross Blue Shield of Tennessee and Highmark Blue Cross Blue Shield of Pennsylvania regarding classification of  high-frequency spinal cord stimulation (SCS) for chronic pain. In an April 2016 medical policy, the insurers classified this type of SCS, which is approved by the FDA, to be experimental and investigational. The letters say beneficiaries should be provided access to this "evidence-based therapy when deemed medically necessary." ASRA pointed out the importance of patient access to non-drug options for chronic pain in light of the U.S. opioid epidemic. (

Company Targeting Heart Failure Raises Funds

June 18, 2016 - CVRx has raised $46 million for development of its potential heart-failure intervention, an implantable neurostimulator that targets the baroreflex to restore autonomic balance through lowering sympathetic activity and raising parasympathetic activity. A pivotal clinical trial involving 310 patients is expected to conclude in September 2017. (Med City News)

Company Developing Neurostimulator for Low Back Pain Raises Funds

June 17, 2016 - Mainstay Medical has raised €30 million through placing shares that represent roughly one-third of all the company's shares. As part of the placement, KCK, a family investment group, is taking ownership of half the shares. The company is addressing certain types of lower back pain through commercialization of an implantable device that stimulates nerves to strengthen muscles that stabilize the lower back. (Irish Times)

Company Launches a Deep Brain Stimulation System in Europe

June 16, 2016 - St. Jude Medical has launched a deep brain stimulation system in Europe that has stimulation leads designed to steer current. The system also allows commercial handheld wireless devices to be used as controllers by patients and physicians. (Mass Device)

Startup's Tibial Nerve Stimulator Receives CE Mark

June 15, 2016 - BlueWind Medical received CE mark approval for a wirelessly powered tibial nerve stimulator to treat overactive bladder. (Fierce Medical Devices)

Grant Will Help Support Clinical Trial of Brain Stimulation to Augment Stroke Recovery

June 15, 2016 - Soterix Medical, Inc. announced the company has received a $2.5 million grant from the National Institute of Neurological Disorders and Stroke to support a Phase II clinical trial of non-invasive brain stimulation for post-stroke aphasia. The company plans to test transcranial direct current nerve stimulation as an adjunctive treatment for aphasia patients. Stimulation will be individualized based on functional MRI results. (Business Wire)

Startup Raises Funds for Development of Closed-Loop Deep Brain Stimulation

June 15, 2016 - The Italian startup Newronika has raised €1.7 million in venture financing to help support development of an adaptive, closed-loop, deep brain stimulation system for Parkinson's disease. The company spun out of the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico in Milan and Università degli Studi di Milano. (FINSMES)

Article Profiles Drugmaker's Bioelectronics Push

June 10, 2016 - An article summarizing an interview by Bloomberg says GlaxoSmithKline plans three clinical trials that combine drugs and other companies' electrical stimulation devices, and aims to develop an implant of its own in 2019. The article said the company's overall investment would be "on par" with the amount that is often seen quoted for "molecular" medicines, that is, in the billions of dollars. It adds that determining how to modulate individual neurons will be a challenge, but it is hoped that ensuing generations of devices can be modified slightly to treat other diseases, making those versions less costly to produce than a medication. The company is limiting its focus to systems that treat the peripheral nervous system. (Mass Device)

Article Features Company's Work on a Neurostimulator for Post-Amputation Pain

May 26, 2016 - An article profiles development by Neuros Medical of emerging electrical devices to block post-amputation pain. (Tech Ohio)

Company Prices Public Offering of Convertible Senior Notes

June 8, 2016 - Nevro Corp. announced its public offering of convertible senior notes will pay an interest rate of 1.75% a year. In addition, the company revised the amount it expected to raise from $125 million to $150 million. (Mass Device)

TV Segment Features Transcranial Magnetic Stimulation Treatment for Depression

June 1, 2016 - News coverage of transcranial magnetic stimulation for depression calls the therapy "a sort of depression fighting helmet" and features one patient describing how she has benefited from the treatment. (KING5)

Device Company Announces Upcoming Financing Round

June 7, 2016 - Nevro Corp. announced it plans to offer $125 million in convertible senior notes to support repayment of a term loan agreement, general corporate purposes, and continued commercialization of its high-frequency spinal cord stimulation system. (Mass Device)

Rechargeable Sacral Nerve Stimulation System Receives CE Mark

June 6, 2016 - Axonics Modulation Technologies, Inc. announced it has received CE mark approval for its rechargeable sacral nerve stimulation (SNS) system. The system is designed to treat overactive bladder, urinary retention, and fecal incontinence. The company also announced publication of a study in Neurology and Urodynamics in April that modeled comparative costs of a rechargeable SNS system versus a non-rechargeable one. (Mass Device)

Visual Prosthetics Company Raises $19.4 Million

June 1, 2016 - Second Sight Medical Products, Inc. said it netted about $19.4 million in a rights offering that was oversubscribed. The company will use the proceeds on the research and development of its visual prosthetics. (Business Wire)

Company Plans Reorganization of Unit That Includes Neuromodulation

June 1, 2016 - Medtronic said its restorative therapies group, which includes neuromodulation, posted a 1% gain over the previous year. This was the smallest growth margin of the company's four divisions. The restorative therapies group will be reorganized into a general-manager model and the focus will shift to diseases and conditions over technology. The company will focus its pain stimulation strategies toward the opioid epidemic. (Twin Cities Business)

Company Receives CE Mark Approval for Neurostimulation Device Targeting Back Pain

May 25, 2016 - Mainstay Medical International plc announced it has received CE mark approval for its implantable neurostimulation system to treat disabling chronic low back pain. The company plans a commercial launch in Germany. These plans include conducting a post-market clinical data follow up. A clinical trial in the U.S. may follow. (Business Wire)

Texas Company to Work With Pittsburgh Researchers on A Bladder-Control Implant for Spine-Injured Patients

May 24, 2016 - InCube Labs of San Antonio, TX has been awarded a $10 million subcontract, part of a U.S. Department of Defense contract, to work with the University of Pittsburgh on developing an implant that could improve or restore bladder function in patients who have suffered spinal cord injuries. (My SA)

Device Company Announces Launch of MRI-Compatible Spinal Cord Stimulation System

May 19, 2016 - Boston Scientific Corporation announced it received FDA approval of its MRI-safe spinal cord stimulation system, which it will launch during the World Institute of Pain annual meeting, taking place May 20 - 23, 2016. The company said the FDA cleared the system for full-body, 1.5 Tesla MRI scans, and that it is designed to deliver multiple waveforms. (Mass Device)

Researchers Model Effectiveness and Costs of Non-invasive Vagus Nerve Stimulation for Cluster Headache

May 16, 2016 - The company electroCore has issued a press release about research published last month showing that non-invasive vagus nerve stimulation for cluster headache is effective and cost-effective, according to scenarios modeled from a German health economy perspective. (PRLog)

Electroceutical Startup Raises $8 Million

May 12, 2016 - An article reports that Silicon Valley startup NeuSpera Medical has raised $8 million in Series A financing for its injectable neuromodulation technology. The company was founded in 2014 as Vivonda Medical, and is targeting applications in electroceuticals, which the article calls "a futuristic field that already has substantial strategic interest." (Fierce Medical Devices)

Company Targeting Gastro-esophogeal Reflux Disease Raises $25 Million

May 12, 2016 - EndoStim, Inc. completed a Series D financing round of $25 million that will go in part toward clinical trials of its neurostimulation therapy for acid reflux. (PE Hub Network)

Company Announces Fast-Track Designation from the FDA

May 11, 2016 - Lungpacer Medical received approval to use the FDA expedited access pathway for its diaphragm pacing system. The system provides temporary transcatheter stimulation of the phrenic nerve to aid weaning patients from mechanical ventilation. (Mass Device)

Device Maker Releases First-Quarter Financial Report

May 11, 2016 - Nuvectra Corporation announced first-quarter financial results. The company's total revenue was $2.1 million, up 76% from the same quarter one year ago. Operating expenses were $8.1 million, a 42% increase from one year ago. The company completed its spin-out March 14. The company established a term loan agreement in March. Overall its net loss for the quarter was $0.70 per share, compared to $0.54 per share in the first quarter of 2015. The first commercial implants began in April for its first product, a spinal cord stimulation system. (Nasdaq)

Company's Pain-Relief Device Sales Were Higher Than Anticipated

May 10, 2016 - First-quarter sales for Nevro Corp. were higher than analysts' forecasts and the company raised its guidance about 2016 anticipated earnings. The company's spinal cord stimulation system received FDA approval last May. (Fierce Medical Devices)

Columnist: Are Non-drug Therapies Gaining Favor?

May 10, 2016 - A column discusses the total lifetime costs of drug therapies compared to neuromodulation therapy and mentions a recent article in Neuromodulation: Technology at the Neural Interface. (Neurotech Business Report)

Company Plans a Stock Offering to Shareholders

May 9, 2016 - Second Sight Medical Products, Inc. is offering its shareholders subscription rights to purchase a proportionate amount of additional stock at $4.25 per share or 85% of the Nasdaq closing price by May 31, 2016. The proceeds will be used to fund operations and research, such as development of a cortical visual prosthesis as well as continuing a post-market clinical study of the company's retinal prosthetic for age-related macular degeneration. (Yahoo Finance)

Company Targeting Urogenital Indications Announces Patents

May 9, 2016 - Axonics Modulation Technologies, Inc. announced it received six U.S. patents relating to implantable neuromodulation technology and recharging systems in the past 12 months. The company said its initial clinical application is sacral neuromodulation to treat urinary and fecal dysfunction, which it said affects more than 100 million adults in the U.S. and Europe. (Yahoo Finance)

Neurostimulator Company Raises More Money in an Over-allotment Offering

May 3, 2016 - Helius Medical Technologies raised an additional $857,083 in an over-allotment to its latest offering, bringing the total to $8.1 million. The company said the proceeds will help fund completion of a clinical registry trial of its portable neuromodulation stimulator to evaluate treating traumatic brain injury, prior to seeking 510(k) clearance from the FDA. The company plans to also pursue indications in multiple sclerosis and stroke. (Mass Device)

Company Raises Capital to Commercialize Obesity-Treatment Neurostimulator

May 3, 2016 - EnteroMedics closed a third tranche in a $25 million offering, bringing in $6.3 million. The company is commercializing an implantable vagus nerve stimulator for obesity treatment. (Mass Device)

Device to Potentially Address Peripheral Nerve Pain Moves Forward in Competition

May 3, 2016 - Bioness, Inc. announced its implantable neurostimulator for peripheral neuropathic pain is a finalist for the 2016 Medical Device Excellence Awards. Results of the competition will be announced in June. (PR Newswire)

Columnist Sees Promise in April Developments in the Neurotechnology Industry

April 2016 - A column by an industry observer says that following St. Jude Medical's acquisition by Abott, other large healthcare firms may take greater interest in entering the neurotech arena. The column adds that proposed U.S. legislation, if passed, would require Medicare to automatically cover newly approved medical devices. Finally, the column notes the FDA is moving toward expediting access to market by considering lowering classification, from class III to class II, of cranial electrical stimulation systems for some indications. (Neurotech Business Reports)

Neuromodulation Company is Acquired by Healthcare Giant

April 28, 2016 - Abbott is acquiring St. Jude Medical, Inc. for $25 billion. The deal provides a broader cardiovascular portfolio and also confers "a leading position in the high-growth neuromodulation market," it was reported today. Abbott, which has product lines in cardiovascular, diabetes, and vision care, will assume or refinance St. Jude's net debt of approximately $5.7 billion. (Street Insider)

New Neurostimulation Company Receives up to $45 Million in Debt Financing

April 22, 2016 - Nuvectra's first disclosed financing is a $40 million loan and $5 million line of credit from Oxford Finance and Silicon Valley Bank. The newly spun-out neurostimulation company's overall market capitalization is about $90 million. (Fierce Medical Devices)

Company Acquires Startup's Neurostimulation Patents

April 22, 2016 - Nexeon MedSystems Inc. has acquired neuromodulation patents from NeuroTek Medical, Inc. related to electrode design and occipital nerve stimulation for migraine headache. NeuroTek created a device that delivers transcutaneous occipital nerve electrical stimulation as an investigational treatment for migraine pain. Nexeon anticipates using this intellectual property in its research into similar technology for cardiovascular disease, cognitive enhancement, and sepsis. (Biospace)

CE Mark Approved for Migraine Prevention Labeling

April 22, 2016 - The company eNeura has received an expanded CE mark for its single-pulse transcranial magnetic stimulation device to prevent migraine, as well as for acute treatment of migraine. (FDA News)

Transcranial Magnetic Stimulation System Maker Announces New European Patent

April 20, 2016 - Nexstim Plc announced the European Patent Office has issued a patent for the company's technology that displays where an electric field is generated on the brain during transcranial magnetic stimulation. (Globe Newswire)

Device Maker Cites Neuromodulation Revenue in Quarterly Earnings

April 20, 2016 - Neuromodulation sales at St. Jude Medical grew 8% in the first quarter and contributed to earnings and revenues the company said were above forecast. (Market Watch)

Neurostimulation Spin-off Completes Private Financing Round

April 19, 2016 - A spinoff from the Swiss Federal Institute of Technology in Lausanne, G-Therapeutics, raised $41 million in a Series A round and debt. The company plans to use the proceeds on clinical trials for an implantable neurostimulation system to restore lower limb function spinal cord injury patients. (Fierce Medical Devices)

Non-invasive Stimulation Startup Raises Capital

April 18, 2016 - Helius Medical Technologies has raised $7.2 million in a Canadian short-form offering and a concurrent private placement in the U.S. The company is completing a clinical trial of non-invasive nerve stimulation for treatment of traumatic brain injury, in preparation for a request for FDA 510(k) clearance and an envisioned U.S. commercial launch. (Med City News)

Spinal Cord Stimulation Leads Receive Pre-Market Approval

April 18, 2016 - Nevro Corp. announced FDA pre-market approval of its spinal cord stimulation leads for use with its high-frequency spinal cord stimulation device, which was FDA-approved in May 2015. (Mass Device)

Company Releases Dorsal Root Ganglion Neurostimulator in the U.S.

April 11, 2016 - St. Jude Medical announced the U.S. launch of its dorsal root ganglion (DRG) neurostimulator, following FDA approval in February. Providers are being trained in use of the device to treat people with chronic pain from complex regional pain syndrome I and II for whom traditional neurostimulation is not sufficiently effective. The company announced the first two procedures in a news release and said it has partnered with implanting chronic pain specialists who will conduct more than 100 procedures in 59 centers nationwide in the first month after launch. (MedGadget)

Clinical Trial of Neurostimulation in Post-Amputation Pain Will Continue Following Interim Analysis of Early Results

April 7, 2016 - Neuros Medical, Inc. announced positive feedback from an analysis of interim results in the company's pivotal clinical study of high-frequency nerve stimulation for post-amputation pain. An independent data monitoring committee analyzed safety and efficacy outcomes for the first 20 patients in the study. Based on that analysis, the clinical trial will continue. The study seeks to ultimately enroll up to 130 patients at 15 institutions. (Business Wire)

Public Body Says National Health Service Can Use Noninvasive Vagus Nerve Stimulation for Chronic Headache

April 1, 2016 - In a news release, electroCore LLC reports that the National Institute for Health and Care Excellence (NICE) has issued guidance on transcutaneous stimulation of the cervical branch of the vagus nerve for cluster headache and migraine. NICE reviewed and summarized results of five clinical trials that documented the degree of benefit experienced by enrollees. The guidance to physicians encourages them to inform patients that evidence of efficacy is uncertain due to the extent and nature of the data published to date, but adds that further research is encouraged and "current evidence raises no major concerns". Based on the guidance issued by NICE, the intervention can now be used in the National Health Service. (PR Newswire)

Company Evaluates Response of Stroke Patients to Different Forms of Noninvasive Stimulation

March 31, 2016 - Nexstim Plc of Finland plans to file for FDA 510(k) clearance for its navigated repetitive transcranial magnetic stimulation system in the second quarter of 2016, the company announced. The system is CE marked, and was undergoing a clinical trial at 12 centers in the U.S. to augment post-stroke arm and hand motor rehabilitation. The sham group received a different stimulation than the patients in the active-treatment arm. After 138 patients were treated, the study reached a futility criterion because both the sham and treatment groups showed clinically meaningful gains, with more than two-thirds of patients in each group responding. The company is filing a patent application on the sham stimulation method, based on this unexpected response. The company is halting the clinical trial and will unblind the data for further analysis. (Globe Newswire)

Retinal Prosthesis Maker Gets CE Mark Approval

March 31, 2016 - Retina Implant of Germany received CE Mark approval for its neuroprosthetic device designed to restore some vision in patients who have retinitis pigmentosa. (FDA News)

Pilot Trial of a Wearable Pain-Relief Device Will Gather Data on Sleep Impact Through a Mobile App

March 31, 2016 - NeuroMetrix will offer its FDA-cleared wearable pain-relief device to people with chronic pain who work for Premera Blue Cross in the Pacific Northwest in a pilot trial in which data on device utilization and sleep quality will be gathered by a mobile app. (FDA News)

Company Launches a Minimally Invasive Neurostimulation Treatment for Overactive Bladder

March 30, 2016 - Medtronic plc has launched a percutaneous tibial nerve stimulation system to treat symptoms of overactive bladder. (Yahoo Finance)

Company Starts to Market Peripheral Nerve Stimulator

March 23, 2016 - Stimwave, LLC said it has begun to market its peripheral nerve stimulator that received 510K approval from the FDA earlier this month. Its indications include upper and lower extremity neuropathies and some pain of the mid or lower back, chest well, abdomen, or pelvic region.The device is wirelessly powered by a wearable fabric patch unit. (Business Wire)

Neurostimlation Company Spinout Concludes With Stock Exchange Listing

March 14, 2016 - Nuvectra Corporation began trading under the symbol NVTR, completing its spinout from Greatbatch, Inc. Nuvectra's chief executive officer, Scott Drees, said the newly independent neurostimulation medical device company will begin focusing on launching its proprietary spinal cord system in the U.S.. (Yahoo Finance)

Company"s Robotic Surgery System to Assist in Deep Brain Stimulation Surgery

March 14, 2016 - Montpellier-based Medtech announced sale of its brain robotic surgery system to the Yale School of Medicine's Comprehensive Epilepsy Center, where its uses will include deep brain stimulation surgery. The company said two additional units were sold in China, bringing their total there to nine. (

Company Says the FDA Has Approved Its Processor to Wirelessly Stream Audio to Hearing Prosthesis

March 14, 2016 - Cochlear announced the FDA approved the company's sound processor that uses wireless technology for users to stream audio directly to their device. The device is intended for people who have higher degrees of mixed-hearing loss. (FDA News)

Company Receives FDA Approval for MRI-Safe Stimulation Leads

March 3, 2016 - Medtronic plc announced it has received FDA approval of its spinal cord stimulation leads that are designed for MRI compatibility. The company expects to begin marketing them later this month. (Mass Device)

Visual Prosthetics Maker Garners $28.2 Million in Investment

March 2, 2016 - Retina Implant of Reutlingen, Germany said it has raised $28.2 million for further commercialization of its subretinal microchip to treat retinitis pigmentosa. The device received CE Mark in 2013 and won reimbursement in Germany in 2014. (Mass Device)  

Neuromodulation Activity Adds to Bottom Line for Company

March 1, 2016 - An analyst report says Greatbatch, Inc.'s cardiac/neuromodulation sales in the fourth quarter grew 44.5%, primarily driven by a neuromodulation product launch. Overall, the company reported adjusted gross earnings of 92 cents a share in the fourth quarter, and an 87.1% increase in sales from the previous year, totaling $317.6 million. (Zacks)

Earnings Report Shows Growth in Neuromodulation Revenue

Feb. 24, 2016 - LivaNova, PLC announced 2015 annual financial results and fourth-quarter results. For the twelve months ended December 31, 2015, worldwide sales were $1.2 billion. In neuromodulation, growth was primarily driven by launch of the company's vagus nerve stimulation system in the U.S. in June 2015, and continued sales in international markets. In the fourth quarter, neuromodulation sales were $92 million, an increase of 25.9% on a constant currency basis. The company said it expects growth in neuromodulation in 2016 to be between 9% and 11%. (Globe Newswire)

Startup Peripheral Nerve Stimulation Company Raises Capital

Feb. 18, 2016 - A startup company spun out of Stanford University has raised $18 million from Google Ventures, Johnson & Johnson Development Corporation, Lux Capital, Action Potential Venture Capital, DRX Capital and Lightstone Ventures, according to the Silicon Valley Business Journal. The company, Cala Health, has a 2014 patent application for a peripheral nerve stimulator to control tremor. (MobiHealthNews)

Overview Summarizes Ongoing Clinical Trials of Vagus Nerve Stimulation for Migraine

Feb. 22, 2016 - ElectroCore has expanded from studying noninvasive vagus nerve stimulation (VNS) in cluster headache. In Europe, the company is now conducting two randomized, double-blind, parallel-group, sham-controlled studies of noninvasive VNS in migraine. One multi-center study on the prevention of migraines attacks has enrolled more than 200 of up to 400 patients. A second study enrolled the first of up to 250 patients at 10 sites in Italy to investigate noninvasive VNS as an acute treatment to reduce pain in migraine attacks. (Life Scientist)

Dorsal Root Ganglion Stimulation is Approved in the U.S. for Complex Regional Pain Syndrome Therapy

Feb. 17, 2016 - St. Jude Medical received FDA premarket approval for its dorsal root ganglion neurostimulation system. The device is designed to treat chronic intractable lower-limb pain in adults who have complex regional pain syndrome. (Modern Healthcare)

Company Receives Broadened FDA Approval for Use of Its Deep Brain Stimulation System in Parkinson's Disease

Feb. 17, 2016 - Medtronic plc received a broader FDA approval for its deep brain stimulation (DBS) system. The system is now approved for patients who have had Parkinson's disease for at least four years, with recent onset of motor symptoms, or who have had longstanding motor complications not adequately controlled by medication. (Fierce Medical Devices)

Pharmaceutical Company Partners with Neurostimulation Device Maker

Feb. 16, 2016 - GlaxoSmithKline has partnered with Nuviant Medical to use its neurostimulation implant systems as a research platform for clinical applications of bioelectronics medicine. Bioelectronics, the company specified, seeks to develop miniaturized implants to interface with the peripheral nervous system to modulate organ function in order to treat chronic disease. (Fierce Medical Devices)

Company Raises Financing for "Neuropriming" Development

Feb. 10, 2016 - Halo Neuroscience announced it has raised $9 million in Series A financing and is pursuing both stroke rehabilitation and athletics with its headphones that are designed to provide brain stimulation to the motor cortex, an effect the company calls neuropriming. (Med City News)

Company Eyes Commercialization of Implantable Therapy for Chronic Low Back Pain.

Feb. 8, 2016 - Mainstay Medical International plc announced 2015 preliminary results and a business update. The Dublin-based company said it awaits CE marking and is preparing to commercialize its implantable device for chronic low back pain in Europe, with the first target market located in Germany. Meanwhile, the company received two more U.S. patents, bringing the total number to seven, and is currently preparing for an international prospective randomized sham-controlled blinded clinical trial, to include sites in the U.S. (Business Wire)

Companies Announce Plans for Directional Deep Brain Stimulation

Feb. 1, 2016 - Aleva Neurotherapeutics announced a strategic development, supply, and manufacturing relationship with the Greatbatch, Inc. subsidiary Greatbatch Ltd. Aleva will license a neurostimulation platform for the field of use of deep brain stimulation for treatment of Parkinson’s disease and essential tremor. Aleva will incorporate its own proprietary electrode technology for directional deep brain stimulation (DBS) along with the in-licensed technology for a 24-channel neurostimulator and related programmers. Aleva is raising a Series C round of financing, led by Greatbatch, for completing a chronic study in 60 Parkinson's disease patients, and to support seeking CE Mark approval for the directional DBS system. Additionally, Greatbatch said it expects to be renamed Integer Holdings Corporation later this year, following its October 2015 acquisition of Lake Region Medical. (GlobeNewswire)

Company Looks to Gain More Capital for Its Visual Prosthesis Pipeline

Jan. 25, 2016 - Second Sight Medical Products, Inc. filed a proposed rights offering with the Securities and Exchange Commission for its existing companies. The company would use the proceeds for an ongoing safety and efficacy trial of its Argus® II Retinal Prosthesis System for the treatment of age-related macular degeneration and development of a visual cortical prosthesis to potentially treat nearly all forms of blindness. (Business Wire)

Company Announces New Head of Neuromodulation Business Unit

Jan. 14, 20i6 - LivaNova, PLC has named former Cyberonics, Inc. executive Jason Richey president of LivaNova's neuromodulation business unit and a member of the executive team. He was previously vice president of global sales and marketing for neuromodulation. (Street Insider)

Device Maker Announces Sales Growth

Jan. 13, 2016 - St. Jude Medical, Inc. expected to report consolidated net sales of approximately $1.447 billion for the fourth quarter of 2015. That is an increase of 7% on a constant currency basis. Sales of its neuromodulation products in the fourth quarter amounted to approximately $128 million, an increase of 9% on a constant currency basis over the fourth quarter of 2014. (Business Wire)

Vagus Nerve Stimulation System Developer Raises $11 Million

Jan. 13, 2016 - Minnesota-based EnteroMedics Inc. brought in $11 million in the 2nd tranche of a $25 million offering, announced in November, of senior amortizing convertible notes. The company received $1.5 million at the initial offering in November 2015. In 45 days, a 3rd tranche of $12.5 million is scheduled. The company has developed a vagus nerve stimulation system to treat metabolic diseases and other gastrointestinal disorders. (Mass Device)

Neurostimulation Device Maker Receives Regional Government Grant in Belgium

Jan. 8, 2016 - Neurostimulation device maker Nuviant Medical received a research grant of €3.4 million from the Walloon Region government and plans to expand manufacturing operations there in a program that incorporates digital healthcare in collaboration with regional innovators. (Fierce Medical Devices)

Company Raises Capital to Support a Clinical Trial of a Neuromodulation Device for Overactive Bladder

Dec. 21, 2015 - Axonics Modulation Technologies announced $38.5 million in Series B financing that it intends to use to support a clinical trial next year of its rechargeable sacral nerve stimulation system in patients with overactive bladder. The company has raised $59 million since it formed in 2013 to commercialize technology licensed from the Alfred E. Mann Foundation. (PE Hub Network)

Forum Focuses on Emerging Neurotechnology

December 2015 - The 15th annual Neurotech Leaders Forum in San Francisco in November featured regulators, funders, and entrepreneurs who discussed emerging technologies and the path to market. Speakers included the FDA's director of Neurological and Physical Medicine Devices, Carlos Pena, who described how FDA intends to decide investigational device exemption requests within 30 days, and other ways the agency is endeavoring to make its processes timely and effective. Other sessions focused on considerations for device security. (Neurotech Business Report)

Company Says Cohort Group Comparison Demonstrates Improvements from Newest Spinal Cord Stimulator

Dec. 16, 2015 - Data presented at the North American Neuromodulation Society meeting in December updated initial results from the long-term LUMINA spinal cord stimulation (SCS) study, initially shown at the International Neuromodulation Society 12th World Congress in June. Boston Scientific Corporation announced the data from four patient groups who were followed for up to 24 months demonstrate that the company's most-recent SCS system provides a 70% improvement in lower back pain relief compared to the previous-generation device. The latest system has 32 contacts and four lead ports, along with programming software that is based on three-dimensional modeling of spinal cords. (Med Device Online)

Company Plans U.S. Clinical Trial of Percutaneous Stimulation in Chronic Migraine

Dec, 11, 2015 - StimRelieve LLC announced FDA investigational device exemption approval to begin a clinical trial of percutaneous, wirelessly powered neurostimulators to treat medically refractory chronic migraine. (Business Wire)

Long-Term Data Show Benefits of Dorsal Root Ganglion Stimulation for Pain Conditions

Dec. 11, 2015 - St. Jude Medical, Inc. announced long-term data presented in a plenary session at the North American Neuromodulation Society meeting show dorsal root ganglion stimulation provides sustained and superior pain relief over traditional spinal cord stimulation in patients with complex regional pain syndrome or peripheral causalgia.The data from the ACCURATE study confirm three-month primary endpoint data that was originally presented at the International Neuromodulation Society World Congress in June 2015. (Business Wire)

Study Results Presented Comparing Tonic and Burst Spinal Cord Stimulation

Dec. 11, 2015 - St. Jude Medical, Inc. announced the SUNBURST study has demonstrated that burst stimulation is superior to traditional tonic spinal cord stimulation in relieving chronic pain. The study results presented in a plenary session at the North American Neuromodulation Society meeting  showed patients preferred burst stimulation and most experienced less paresthesia or none. (Business Wire)

Company Announces Mobile Application Partnership

Dec. 11, 2015 - Medtronic plc is expanding a partnership with Samsung Electronics America that began in june with smart devices for diabetes to now also develop Android mobile applications for neuromodulation devices. (Fierce Medical Devices)

Company Anticipates Medicare New Device Payment Specifications in January

Dec. 10, 2015 - Nevro Corp. announced the Centers for Medicare & Medicaid Services approved a transitional pass-through payment, under a new device category, for high frequency stimulation under the Medicare hospital outpatient prospective payment system to begin Jan. 1, 2016. (Street Insider)

Equipment Manufacturer Expands Access to Implantable Pulse Generator Platform Technology

Dec. 10, 2015 - Evergreen Medical Technologies, Inc. announced it is expanding product development services through access to AdvaStim's customizable, modular core electronic components for implantable pulse generators, the ASICore platform. These components can be applied to various neurostimulation applications, from spinal cord stimulation and deep brain stimulation to prosthetic control. (Business Wire)

Company Says Injectable Spinal Cord Stimulation System Received Marketing Clearance in Europe

Dec. 10, 2015 - Medical device distributor Stimwave Neuro LP announced CE Mark approval for Stimwave Technologies Incorporated's Freedom spinal cord stimulation system for pain relief of the back or legs. The system incorporates up to eight electrode contacts and an embedded chip, that are introduced into the body through a needle. (Business Wire)

Company Announces Its Deep Brain Stimulation Systems Have Expanded Conditional Approval for MRIs

Dec. 9, 2015 - Medtronic plc announced that systems within its Activa® portfolio of deep brain stimulation devices have received FDA approval for full-body magnetic resonance imaging under specific conditions of use. (Street Insider)

Company Announces FDA Approval of Its Neuromodulation Device for Chronic Back and Leg Pain

Dec. 9, 2015 - Stimwave Technologies announced it has received FDA clearance to market its  wireless neuromodulation device for relief of chronic back and leg pain. (Digital Journal)

Results Published in Clinical Trial of Vagus Nerve Stimulation During Stroke Rehabilitation; Company Plans Further Research and Announces Additional Funding

Dec. 9, 2015 - International Neuromodulation Society member Jesse Dawson, MD was quoted in an article about a small controlled study he and colleagues published in Stroke that suggests pairing vagus nerve stimulation with upper-limb rehabilitation is safe and feasible after stroke. Based on those results, MicroTransponder, Inc. is conducting a 20-patient followup study in the U.S. and the U.K. The privately held company announced that it has closed a $5.5 million round of funding to support its activities. (Medgadget)

Company Anticipates Distributing Its Transcranial Magnetic Stimulation Systems in Mexico in 2016

Dec. 8, 2015 - Brainsway Ltd. announced an exclusive distribution agreement with moksha8 in Mexico, where the distributor plans to make Brainsway's deep transcranial magnetic stimulation system available in 2016 as a treatment for major depressive disorder. (Globes)

Company Receives Clearance to Test Implantable Device in Craniofacial Neuropathic Pain

Dec. 2, 2015 - StimRelieve LLC, announced it has received an FDA Investigational Device Exemption for a clinical trial of its injectable, wirelessly powered, stimulator to test the device for the treatment of refractory craniofacial neuropathic pain. Its Halo CFNS system is powered by an external transmitter placed on the ear. (Businesswire)

Stimulation Therapy for GERD Receives Approval in Brazil

Dec. 2, 2015 - EndoStim announced that ANVISA, the Brazilian health authority, approved its minimally-invasive therapy for gastroesophageal reflux disease (GERD) in Brazil. The EndoStim II LES Stimulation System is intended for patients who "may not be ideally treated with medication therapy," the company said. The stimulation targets the lower esophageal sphincter between the stomach and esophagus to improve or strengthen its function. (PR Newswire)

Projected Sacral Nerve Stimulation Costs to Be Presented at NANS

Dec. 2, 2015 - Axonics Modulation Technologies, Inc. announced that an abstract will be presented on Dec. 12 at the North American Neuromodulation Society (NANS) meeting that compares estimates of long-term treatment costs for overactive bladder using either rechargeable, or non-rechargeable, sacral nerve stimulators (SNS). The analysis is based on a model that uses a U.S. payer perspective. Results indicate a rechargeable system would have significantly lower costs per patient. Axonics is developing a rechargeable SNS system. (Businesswire)

Petition for Review Denied on U.S. Patent for High Frequency Spinal Cord Stimulation

Dec. 1, 2015 -  Despite two petitions challenging validity of some patent claims for high frequency spinal cord stimulation, the Patent Trial and Appeals Board (PTAB) at the U.S. Patent Office has decided to not conduct an inter partes review, the patent-holder, Nevro Corp., announced. The PTAB decided against holding a review after considering two petitions filed in May 2015 by Boston Scientific Corporation that challenged certain claims in Nevro's patent (U.S. Patent No. 8,359,102). (Fierce Medical Devices)

Company Announces FDA Approval for Spinal Cord Stimulation System

Nov. 30, 2015 - Greatbatch, Inc. announced FDA approval for its spinal cord stimulation system, Algovita®, which was developed by the company's subsidiary, QiG Group. The subsidiary is in the process of being spun out as Nuvectra Corporation, a process that is expected to be complete in the first quarter of 2016. (Nasdaq)

Company Opens an International Headquarters in Germany

Nov. 25, 2015 - Autonomic Technologies, Inc. is opening a new international headquarters in Munich, Germany. The company is commercializing sphenopalatine ganglion stimulation for cluster headache, and its device has received CE Mark in Europe. (Market Wired)

Deep Brain Stimulation Surgery Performed with Continuous MRI Guidance

Nov. 23, 2015 - MRI Interventions, Inc. announced the first MRI-guided electrode placement for deep brain stimulation surgery in Arizona, at the Banner - University Medical Center in Tucson. (CNN Money)

Group Eyes Commercialization of Neuromodulation to Control Bleeding

Nov. 22, 2015 - A nerve-stimulation device under development to control bleeding is expected to be subject to a new spin-out company in three months, as a step toward preparation for clinical trials. (Innovate Long Island)

Company Announces FDA Approval of Spinal Cord Stimulation System

Nov. 19, 2015 - St. Jude Medical announced FDA approval of its Proclaim Elite Spinal Cord Stimulation System, a non-rechargeable device that is upgradable to allow for new simulation waveforms and software updates. The patient controller and physician programmer use wireless and mobile technology for use during a trial phase and for tailoring stimulation parameters, respectively. (Fierce Medical Devices)

Company Says Its Device to Address Heart Failure Will Have Expedited FDA Review

Nov. 19, 2015 - Minneapolis-based CVRx announced that its neuromodulator to treat heart failure is the fifth device to enter the six-month-old FDA Expedited Access Pathway. The device is designed to reduce the workload of the heart through modulating the baroreflex system that helps control blood flow. The device activates the baroflex through the afferent (sensory) pathway, helping to restore autonomic balance between the sympathetic and parasympathetic systems. (Fierce Medical Devices)

Company Receives Clearance to Market Non-Invasive Stimulation System in Europe

Nov. 16, 2015 - NeuroSigma Systems announced CE Mark approval for its external trigeminal nerve stimulation system to treat attention-deficit hyperactivity disorder in people aged 7 years or older. (Mass Device)

Another Partner is Announced for Diaphragm-Pacing System

November 2015 - Oberlin, Ohio-based Valtronic is partnering with Synapse Biomedical to commercialize a third-generation, fully implantable diaphragm pacing technology. Valtronic and other partners plan to provide matching funds for the commercialization, which is being supported by a $3 million economic-development grant from Ohio Third Frontier. The device is also being commercialized in Asia with help from another partner, USCI Japan Ltd. (U.S. Tech)

Company Plans to Present Peripheral Nerve Stimulation Data Next Month

Nov. 12, 2015 - Israel-based BlueWind Medical plans to present details of its miniature leafless neurostimulator clinical trial in neuropathic pain patients during the North American Neuromodulation Society meeting in Las Vegas in December. The study was performed in four centers in Belgium and Poland, with up to six months' follow-up. (PR Businesswire)

Company Reports on Past Fourth Months of Activities

Nov. 9, 2015 - Mainstay Medical International plc issues an Interim Management Statement from July 1, 2015 to the present. The statement said that the company submitted an application for CE Mark for its neurostimulation system for chronic low back pain, closed a debt financing for up to $15 million, and announced issuance of three U.S. patents during that period. (Business Wire)

Patient Receives New Neurostimulator Device to Treat Heart Failure

Nov. 5, 2015 - A patient in Croatia is the first to begin using a catheter-based neurostimulator device to treat congestive heart failure, Enopace Biomedical, announced. The leadless, active miniature stimulator and is implanted in a 30-minute percutaneous procedure, and is designed to increase cardiac efficiency by reducing left ventricular workload. (PR Newswire)

Responsive Neurostimulation System Receives Recognition

Nov. 4, 2015 - NeuroPace, Inc. announced it received an award that recognizes its responsive neurostimulation system as the most promising new product of the year. The award was presented at the 2015 Phoenix Medical Device CEO Conference, which is comprised of medical device and diagnostic industry executives. (Business Wire)

Neuromodulation Company Announces New Investment

Oct. 26, 2015 - Helius Medical, which is commercializing a portable neuromodulation stimulator in several countries in Asia, raised $2 million in new financing from an anonymous donor, and intends to raise up to $12.3 million for the round. (Mass Device)

Company Acquires Technology for Multi-Coil Transcranial Magnetic Stimulation

Oct. 20, 2015 - Rio Grande Neurosciences announced it has acquired Cervel Neurotech’s multi-coil transcranial magnetic stimulation technology, including all related patent applications, issued patents, trademarks and equipment. (Business Wire)

Neuromodulation Company Undergoes Merger

Oct. 19, 2015 - The merger between neuromodulation company Cyberonics, Inc. and Sorin S.p.A. was completed and the new company, LivaNova PLC began trading on NASDAQ and the London Stock Exchange. Besides its existing portfolio in cardiac surgery and neuromodulation, LivaNova is pursuing therapies for heart failure, mitral valve repair, and sleep apnea. (Globe Newswire)

Company Receives Medical Coverage Decision in Germany

Oct. 13, 2015 - EndoStim announced that in 2016, approved treatment with its device for gastroesophageal reflux disease will be routinely reimbursed in Germany. (PR Newswire)

Neurostimulation Company Strikes Development Agreement in Asia

Oct. 13, 2015 - Helius Medical has entered into a $7 million agreement with the Hong Kong-based investment and development company A&B Company Limited. In the sales and licensing transaction, A&B will acquire certain Asian patents, patent applications, and product support material to develop and commercialize the Portable Neuromodulation Stimulator, PoNS™, in China, Hong Kong, Macao, Taiwan and Singapore. A news release mentions A&B's interest in its potential as a treatment for chronic neurological symptoms of traumatic brain injury. Helius said it will repay $2 million drawn down from A&B's provision of a $7 million credit facility by issuing 2.1 million shares of Helius at 96¢ per share and 1 million 3-year warrants at $1.44 per share. (Mass Device)

Device Maker Says Deep Brain Stimulation Patient is the First in the U.S. to Receive a New Anti-Infective Implant

Oct. 8, 2015 - Medtronic announced the first patient use of its Tyrx infection-fighting envelope, which it is launching for use with deep-brain stimulation devices in the U.S. The device releases two anti-microbial drugs, minocycline and rifampin, for seven days. The envelope then dissolves over roughly nine weeks. Medtronic acquired Tyrx for $160 million in January 2014 and received 510(k) clearance from the FDA for its use with neurostimulation implants, including sacral nerve stimulators, spinal cord stimulators and vagus nerve stimulators. Tyrx won CE Mark approval for cardiac devices in September 2014. (Mass Device)

Company Plans Clinical Trial of Injectable Tibial Nerve Stimulator

Oct. 8, 2015 - StimGuard announced FDA Investigational Device Exemption approval to launch a clinical trial this winter of its percutaneously implantable tibial nerve stimulation device to treat overactive bladder. (Sys-Con Media)

Bioelectronic Medicine Center Names a Managing Director

Oct. 7, 2015 - International Neuromodulation Society (INS) member Chad Bouton will leave his research leadership role at Battelle to become a managing director of the Feinstein Institute’s new Center for Bioelectronic Medicine. At Battelle, his work included a project to develop neural implants to bypass spinal cord damage and return some voluntary hand and arm movement to a patient with paralysis (described in an announcement of the 2015 INS abstract winners).  (Innovate LI)

Company's Trial Stimulation System Receives Expanded FDA Approval

Oct. 2, 2015 - Medtronic plc was reported to have received expanded FDA approval for its Verify Evaluation System that allows basic evaluations of patient benefit from sacral nerve stimulation for bladder or bowel control. The system has a wireless touchscreen and is used in conduction with trial stimulation of three to seven days. (FDA News)

Company Raises Funds to Pursue a Clinical Trial of a Noninvasive Device for Tinnitus

Sept. 29, 2015 - Neuromod Devices  Ltd. of Ireland as raised €5.5 million from Fountain Healthcare Partners to fund clinical trials in the U.S. for its bi-modal system to treat some forms of tinnitus. The system uses simultaneous auditory stimulation in the ear and sensory stimulation on the tongue. The device received CE Mark approval in Europe in October 2014 and a U.S. patent September 2015. (Irish Times)

Company Halts Plans for Initial Public Offering

Sept. 28, 2015 - According to an SEC filing, NeuroSigma Systems has decided to not pursue an initial public offering at this time. The Los Angeles-based company had registered for an initial public offering on the NASDAQ last August. The company is marketing its external trigeminal nerve stimulation system in Canada and Europe as an adjunctive treatment of drug-resistant epilepsy and major depressive disorder. The FDA also has permitted an investigational device exemption for clinical trials in the U.S. (MedCity News)

Companies Receive Clearance for Merger

Sept. 23, 2015 - The High Court of England and Wales approved the $2.7 billion merger of Cyberonics and the Sorin Group, now known as LivaNova. The merger will go into effect October 19, according to the companies. (Mass Device)

Company Announces European Approval for Deep Brain Stimulation Technology

Sept. 22, 2015 - St. Jude Medical announced it has received European CE Mark approval for its Infinity deep brain stimulation (DBS) device, and a directional lead that permits physicians to "steer" current to different targets. The DBS device incorporates Bluetooth connectivity that allows patients and physicians to use some Apple™ mobile devices as wireless controllers. (Mass Device)

Company Receives Funding to Develop Wearable Sensors for Deep Brain Stimulation Programming

Sept. 21, 2015 - The National Institute of Neurological Disorders and Stroke is providing $1.9 million in Phase II Small Business Innovation Research funding to Cleveland-based Great Lakes NeuroTechnologies to integrate their wearable sensors into a platform for programming deep brain stimulation (DBS) systems. The company's wearable sensors were initially used for assessing Parkinson's disease. The integrated system should provide real time, closed-loop feedback to adjust DBS programming. (PR Newswire)

Company Reports Use of Its Peripheral Nerve Stimulator

Sept. 16, 2015 - Bioness, Inc.'s StimRouter™ peripheral nerve stimulator has FDA clearance for adjunctive use to treat chronic, intractable pain of peripheral nerve origin. The company announced its first commercial use occurred in Cleveland. The system is a minimally invasive prescription device with an implanted lead, external pulse transmitter, and conductive electrode that is powered transdermally. (BioPortfolio)

Non-rechargeable Deep Brain Stimulation System Receives European Marketing Approval

Sept. 14, 2015 - Boston Scientific Corporation announced CE Mark designation for its Vercise non-rechargeable, primary cell, deep brain stimulation (DBS) system for patients with Parkinson's disease, primary and secondary dystonia, and essential tremor. The system has an eight-contact directional lead with multiple independent current control. The non-rechargeable Vercise primary cell system is not available in the U.S., although its counterpart, the rechargeable Vercise DBS system, is cleared in the U.S. for investigational use to evaluate its effectiveness in Parkinson's disease in the INTREPID study. (Med Device Online)

Company Extends Equity Financing Round

Sept. 8, 2015 - SetPoint Medical, Inc., which is developing bioelectronic therapy for inflammatory disease, has raised an additional $25 million in an extension of its Series C equity financing, bringing the total raised to $43 million. Current investors in the Valencia, CA-based company include Morgenthaler Ventures, Foundation Medical Partners, Topspin Partners, Covidien Ventures, Action Potential Venture Capital Limited and Boston Scientific. (PE HUB)

Company Releases Data in Clinical Trial of Neurostimulation Device for Back Pain

Aug. 31, 2015 - Mainstay Medical International plc announced positive results from the international clinical trial of its neurostimulation device to treat chronic disabling back pain by stimulating nerves for the muscles that stabilize the lumbar spine. In 47 patients who had at least 90 days of follow-up, the company said, 63% had clinically important improvement in back pain and 72% of patients improved who had no financial compensation related to back pain. The clinical trial is being conducted prior to application for CE Mark approval. (Business Wire)

Transcranial Magnetic Stimulation System Cleared for U.S. Use in Certain Cases of Depression

Aug. 28, 2015 - Denmark-based MagVenture, Inc. announced its MagVita transcranial magnetic therapy (TMS) system has received FDA clearance for the treatment of major depressive disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. The company said it is the fourth to receive clearance for this technique. Its system was CE marked in the European Union in 2011. (PR Newswire)

U.S. Patent Issued for an Approach Under Development to Address Low Back Pain

Aug. 26, 2015 - Mainstay Medical International plc announced issuance of a new U.S. patent, “Apparatus and Methods for Rehabilitating a Muscle And Assessing Progress of Rehabilitation.” The company is developing a new implantable neurostimulation system to treat chronic low back pain. (Business Wire)

Device Maker Announces CE Mark for MRI-Conditional Implantable Pulse Generator

Aug. 24, 2015 - St. Jude Medical Inc. announced receiving CE Mark approval for magnetic resonance imaging-conditional labeling of its soon-to-be-launched implantable pulse generator, the Prodigy MRI chronic pain system, saying the approval applies with select leads. (Business Wire)

Device Developer Announces New Financing

Aug. 24, 2015 - Mainstay Medical International plc has secured $15 million in debt financing for commercialization of its neurostimulation device that is designed to address low back pain by contracting the muscles that provide stability. The funding from IPF Partners includes milestone payments for progress toward CE Mark approval of the device for the Dublin-based company. (Business Wire)

Non-invasive Neurostimulation Company Raises Capital

Aug. 19, 2015 - A company that is developing a therapy for loss of the visual field that involves 10 daily sessions of non-invasive electrical brain stimulation, EBS Technologies of Berlin, has raised 1.1 million Euros. The external device, operated by a technician, delivers alternating current to the retina. The stimulation is intended to activate the optic nerve and visual cortex, with the stimulation adjusted in response to monitoring of the patient's EEG. (Market Watch)

Consultants Foresee Broader Role for Neuromodulation

Aug. 13, 2015 - A product design innovator in the U.K., Cambridge Consultants, is publicizing its vision of future neuromodulation devices that it says might address what a news column terms  "lifestyle" issues -- such as migraine, obesity and incontinence. (Business Weekly)

Executive Changes Take Place at Company that Develops Neuromodulation Systems to Address Vision Problems

Aug. 13, 2015 - Second Sight Medical will get a new CEO this month when Robert Greenberg, MD, PhD steps down from that position and becomes chairman of the board, replacing Alfred Mann who will become chairman emeritus. The new CEO, Will McGuire, was an executive at medical-device-industry companies Volcano, Covidien and AtheroMed. An article notes that Greenberg had said the company intends to treat most types of blindness, such as glaucoma and diabetic retinopathy. The company's next-generation device "would bypass the retina with an electrode array implanted directly on the portion of the brain that deals with signals from the retina." (Mass Device)

Neuromodulation Device Developer Acquired by Pharmaceutical Firm

Aug. 11, 2015 - Dublin-based Allergan announced it has closed its purchase of dry-eye disease, neuromodulation-device developer Oculeve for $125 million in up-front payments plus commercialization milestone payments. (Mass Device)

Company Names Two Business Leaders for Its Proposed Spin-out

July 30, 2015 - Greatbatch Inc., proposes a tax-free spin-off of its subsidiary, the QiG Group, into a medical device company, Nuvectra Corporation. In a Form 10 registration statement filed with the U.S. Securities and Exchange Commission, Greatbatch said neuromodulation industry veteran Scott Drees will be chief executive officer of Nuvectra; and Joseph A. Miller, Jr., PhD, its director and chairman of the board. (Globe Newswire)

Wirelessly Controlled Spinal Cord Stimulation System Receives FDA Approval

July 16, 2015 - The FDA has approved St. Jude Medical's Invisible Trial System, which patients can control with an iPod Touch and clinicians can program and track with an iPad Mini. The wirelessly controlled trial spinal cord stimulation system includes a small external pulse generator. (Fierce Medical Devices)

Device Company Targeting Low-Back Pain Announces Two U.S. Patents

July 15, 2015 - Mainstay Medical International plc announced issuance of two U.S. patents concerning its neurostimulation therapy for chronic low back pain. The company's device stimulates muscles in the lower spine to provide more control over these stabilizing muscles. (Business Wire)

Article Describes Prototype Device Intended to Guide Placement of Neurostimulators

July 15, 2015 - An article about a prototype neurostimulator-delivery tool in development by Cambridge Consultants says the Chimaera hand-held instrument is designed to be used in conjunction with a wearable optical device such as Google glass to provide the operator a visual overlay of the target area. It combines pre-operative 3D imaging and real-time sensing of nerves. (Reuters)

Company Announces Patent Allowance for High-Frequency Peripheral Nerve Stimulation

July 14, 2015 - Bioness, Inc. received clearance from the U.S. Patent Office for a patent claiming use of high-frequency stimulation with its implantable peripheral nerve stimulation device, StimRouter. The device is FDA-approved to treat chronic, intractable pain of peripheral nerve origin as an adjunct to other modes of therapy. (Business Wire)

Contract Finalized to Support Clinical Trial of Neuromodulation Device to Address Balance Issues Arising from Traumatic Brain Injury

July 7, 2015 - Helius Medical Technologies, Inc.'s  NeuroHabilitation Corporation division has entered into a cost-sharing contract with the U.S. Army Medical Research and Materiel Command to support a clinical trial investigating the safety and effectiveness of the company's non-invasive Portable Neuromodulation Stimulator (PoNS™) for the treatment of balance disorder in patients with mild-to-moderate traumatic brain injury. The (PoNS™) device is placed on the tongue to stimulate cranial nerves that innervate muscles there. (Business Wire)

Firm Acquires Developer of Dry-Eye Neurostimulation Therapy

July 6, 2015 - Allergan of Dublin, Ireland will pay $125 million acquire South San Francisco-based Oculeve, a development-stage company that is developing a nasal neurostimulation device designed to increase tear production in patients with dry eye disease. The deal includes milestone payments for development of Oculeve's OD-01 neurostimulation therapy. Two pivotal trials are planned, with commercialization potentially occurring in 2017 after FDA approval, the company said. (Mass Device)

Future Name of Newly Merged Company Announced

June 25, 2015 - Sorin Group and Cyberonics said when their merger is complete the new company will be named LivaNova. Its three business units in cardiac surgery, cardiac rhythm management and neuromodulation will have headquarters in Mirandola, Italy; Clamart, France; and Houston, Texas, respectively. (Mass Device)

FDA Approves Deep Brain Stimulation System

June 12, 2015 - The U.S. FDA approved St. Jude Medical Inc.'s rechargeable Brio deep brain stimulation (DBS) system for management of medication-resistant motor symptoms of Parkinson's disease and essential tremor. The DBS system is the second to receive FDA approval, with Medtronic's Activa system approved in the U.S. in 1997 for essential tremor and in 2002 for Parkinson's disease. (FDA)

Device Company Announces Financing Round

June 9, 2015 - WISE Srl, which is developing next-generation neurostimulation leads, announced the closing of a EUR 3 million series A financing round, led by Principia SGR, an Italian Venture Capital firm. Existing investors High-Tech Gründerfonds, Atlante Seed and b-to-v Partners joined the round alongside with three new investors Atlante Ventures, F3F and Antares. (WISE Srl)

Company Announces Name Change as Commercialization Starts for Spinal Cord Stimulation System

June 5, 2015 - Algostim, LLC, a subsidiary of Greatbatch, Inc.'s QiG Group, announced it will now do business as Nuvectra. The medical device company will commerciallze the Algovita spinal cord stimulation system to treat chronic intractable pain of the trunk and/or limbs. (NASDAQ)

Company Announces Launch of Compact Spinal Cord Stimulator System

June 5, 2015 - Boston Scientific announced the European launch of the Precision Novi™ spinal cord stimulation system at the 12th World Congress of the International Neuromodulation Society. The 16-contact primary cell (non-rechargeable) device has CE Mark approval for the treatment of chronic pain. (

Company Announces App-Based, Wireless Neuromodulation Trialling System

June 4, 2015 - St. Jude Medical, Inc. announced CE Mark approval and the European launch of its Invisible Trial System, an app-based and wireless neuromodulation programming system that uses Apple™ iPod touch™ and iPad mini™ technology. The system consists of an external pulse controller, a patient iPod touch controller, and Bluetooth communication function that eliminates the programming trial cable. (Med Device Online)

FDA Approves Vagus Nerve Stimulation System That Responds to Heart Rate Change in Epilepsy Patients

June 2, 2015 - Cyberonics announced FDA approval for its AspireSR generator designed for vagus nerve stimulation to treat drug-resistant epilepsy. It uses a proprietary, customizable cardiac algorithm to detect relative heart-rate increases and deliver automatic stimulation. (Mass Device)

Results Announced for Two Overactive Bladder Patients Receiving Wirelessly Powered Tibial Nerve Stimulation Since August 2014

May 28, 2015 - StimGuard LLC announced two patients who received injectable tibial stimulator in August 2014 for overactive bladder have ongoing reduction of voiding episodes and more than 80% relief. The treatment is carried out at night using a sock to cover the stimulation area. The wirelessly powered implant delivers stimulation that the company said enables the brain to remap specific urge signals in a fashion similar to acupuncture, but permanent. The company plans to complete regulatory studies for CE Mark in 2015 and seek FDA approval in 2016. (Business Wire)

Company Launches a Next-Generation Device for GERD in Europe

May 18, 2015 - EndoStim announced CE Mark approval and European launch of its second generation system, EndoStim II, to treat gastroesophageal reflux disease (GERD). (PR Newswire)

Sacral Neuromodulation Device Company to Present at Meeting

May 20, 2015 - Axonics Modulation Technologies, Inc. announced that it has been selected to present its technology advancements during the Innovations in Neuromodulation session at the International Neuromodulation Society's 12th World Congress on June 6th in Montreal. The company makes an implantable sacral neuromodulation system to manage chronic intractable urinary and fecal dysfunction. The system has a rechargeable implantable pulse generator designed to be small and long-lasting. (Business Wire)

Enrollment is Completed in a Pilot Clinical Trial Addressing Balance Issues in Multiple Sclerosis

May 20, 2015 - Helius Medical Technologies has completed enrollment for its pilot clinical trial at the Montreal Neurological Institute in which 14 patients with multiple sclerosis will be treated for balance and gait symptoms over the course of 14 weeks, undergoing a physiotherapy protocol combined with noninvasive stimulation of cranial nerves using the Portable Neuromodulation Stimulator (PoNS™). (Business Wire)

First Patient in Canada Receives Burst-Mode Spinal Cord Stimulator Implant

May 19, 2015 - Health Canada approved St. Jude Medical's Prodigy™ spinal cord stimulation system with burst technology, the company announced. The first Canadian patient was implanted with the system earlier this month by Ivar Mendez, M.D., Ph.D, FRCSC, FACS at Saskatoon Health Region’s Royal University Hospital. (Market Watch)

Company Receives Permission to Start a U.S. Clinical Trial of a Needle-Implanted, Wirelessly Powered Device in Overactive Bladder Patients

May 11, 2015 - Privately held StimGuard announced the FDA has approved the start of a clinical trial to evaluate a micro-sized device for overactive bladder (OAB) that can be placed completely through a needle. The announcement says the implant is wirelessly powered by an external, "electroceutical" microchip from Stimwave, a company founded by StimGuard's co-founder, which delivers small pulses of energy to electrodes near surrounding nerves. The StimGuard-device clinical trial is due to start in the U.S. in the summer of 2015. (Business Wire)

Device Maker Raises $38 Million in Financing

May 12, 2015 - Autonomic Technologies, Inc. announced it has received a series D round of financing that raised $38 million. The company said it will use the money to expand its marketing in Europe of Pulsante™, its microstimulator to treat severe headaches, and to fund an ongoing clinical study of the device in the U.S. to treat chronic cluster headache. Pulsante™ has received CE mark approval in Europe for treatment of cluster headache. (Military Technologies)

Company Faces Patent-Claims Challenge

May 11, 2015 - Nevro Corp. said Boston Scientific Corporation has filed two petitions at the U.S. Patent Office for inter partes review of claims that were previously granted to Nevro. A inter partes  petition challenges patent claims based on prior art and publication. (CNN Money)

FDA Approves Paresthesia-Free Spinal Cord Stimulation System

May 8, 2015 - The FDA has approved the Senza system, Nevro Corp.'s spinal cord stimulation device that relieves trunk or limb pain without paresthesia. The company said in announcing the approval that the FDA is not restricting patients receiving the therapy from operating motor vehicles, that the system has 3T-conditional MRI compatibility, and received "superiority" labeling from the FDA. The FDA based its approval on a clinical study that showed 75% of patients treated had their chronic pain reduced by 50% within three months. Implant site pain and device lead dislocation were among the adverse events reported. (PR Newswire)

Device Company Completes Acquisition of Developer of Dorsal Root Ganglion Spinal Cord Stimulator

May 4, 2015 - St. Jude Medical announced it has completed acquisition of Spinal Modulation, Inc. The acquisition was completed on May 1. Spinal Modulation developed the Axium™ spinal cord stimulation system. That system has approval in the European Union and Australia. Results of a U.S. clinical trial, ACCURATE, will be presented at the International Neuromodulation Society 12th World Congress in June in Montreal, according to the company's announcement. (Business Wire)

Manufacturer Announces Plans to Spin Out Device Company

April 30, 2015 - Greatbatch, Inc. said it expects to spin off its QiG Group subsidiary, Algostim LLC, by the end of 2015, in order to create a new publicly traded company focused on commercializing the Algovita spinal cord stimulation system, which Greatbatch would continue to manufacture. (GlobeNewswire)

Company Announces FDA Approval of Spinal Cord Simulation System and Leads

April 30, 2015 - St. Jude Medial, Inc. said it has received FDA approval of its Protégé MRI™ spinal cord stimulation system, as well as approval for MRI compatibility of the company’s 60cm Octrode™ percutaneous leads. The leads received MR-conditional labeling for use with the Protégé MRI system. (Market Watch)

Sacral Neuromodulation Developer Raises Capital

April 30, 2015 - Axonics Modulation Technologies of Irvine, Calif. was reported to have raised $17.3 million, according to a regulatory filing. The company is developing sacral neuromodulation (SNM) technology to address bladder and fecal incontinence. A news article said the financing, on top of $32.6 million last year, is "proof that this neuromodulation trend [SNM] is really taking off." (Med City News)

Company Whose Stimulator Addresses Restless Leg Syndrome Announces U.S. Patent

April 30, 2015 - Sensory NeuroStimulation Inc., which produces a non-pharmacological stimulator for Restless Leg Syndrome, announced issuance of a U.S. patent covering technologies noninvasive treatment device, Relaxis (TM). (Business Wire)

Device Company Strikes Strategic Agreement With Maker of Surgical Navigation Software

April 27, 2015 - Boston Scientific, Inc. announced that in select countries, along with its Vercise™ deep brain stimulation system, it will begin distributing Brainlab AG's surgical planning and navigation portfolio. The Vercise system is available to treat Parkinson's disease, tremor and dystonia in Europe, Israel, and Australia as well as in some parts of Latin America and Asia Pacific. A U.S. clinical trial, INTREPID, is currently enrolling patients to evaluate the system's safety and effectiveness for the treatment of Parkinson's disease. (PR Newswire)

Poster: No Serious Cardiovascular Effects from Noninvasive Vagus Nerve Stimulation

April 27, 2015 - A poster at the American Academy of Neurology annual meeting showed no meaningful cardiovascular adverse effects in 29 patients who use electroCore’s non-invasive vagus nerve stimulation as a home treatment for asthma. (Business Wire)

Deep Brain Stimulation System Receives European Approval for Full-Body MRI Scanning

April 22, 2015 - Medtronic announced that European regulators have approved the use of full-body MRI scans in patients who have one of their Activa deep brain stimulation systems. (Mass Device)

Company Raises Series B Financing for System to Treat Depression

April 21, 2015 - Boston-based Tal Medical has raised $14 million in Series B financing, led by PureTech Ventures, to further develop its low-field magnetic stimulation system for use in depression and bipolar disorder. (Med City News)

Device Maker Exercises an Acquisition Option for $175 million, adding Dorsal Root Ganglion Stimulation to Its Portfolio

April 20, 2015 - St. Jude Medical, Inc. announced that, for $175 million and sales-based milestone payments, it will exercise its option to acquire Spinal Modulation, Inc., which has submitted a PMA application for marketing approval of its Axium™ system for stimulation of the dorsal root ganglion to manage intractable chronic pain. The system has received a CE Mark and is subject to a U.S. clinical trial, ACCURATE. The company said in its acquisition announcement that results from the clinical trial will be presented at the International Neuromodulation Society's 12th World Congress in June in Montreal. St. Jude Medical made an initial $40 million equity investment in Spinal Modulation in 2013.  (Business Wire)

U.S. Regulators Approve Merger Involving Vagus Nerve Stimulation Device Maker

April 14, 2015 - Cyberonics and Sorin Group announced approval from U.S. anti-trust regulators of their all-stock merger, which is expected to close by the end of the 3rd quarter. (Mass Device)

Privately Held Company Appoints Medical Advisory Board Chair

April 3, 2015 - Stimwave Technologies Incorporated announced it has appointed Gabor Racz, MD, as chair of its medical advisory board. The privately held company is developing wirelessly powered, injectable, microtechnology neurostimulators. Widely acknowledged for his leadership in pain medicine, Dr. Racz is emeritus chairman of the Department of Anesthesiology at Texas Tech University Health Science Center, and belongs to the International Neuromodulation Society. Other INS members on the Stimwave board are David Kloth, MD, and Ralph Rashbaum, MD. (Business Wire)

Privately Held Firm Announces Patent Allowing "Beat Technology" Spinal Cord Stimulation Claims

March 20, 2015 - Privately held Meagan Medical, Inc., a research arm of RS Medical based in Vancouver, WA announced issuance of a U.S. patent for delivering high frequency stimulation to the spinal cord with the ability to direct a higher beat output toward the spinal column. The patent includes claims for delivering stimulation with base frequencies between 500 Hz to 20 kHz while generating a directionally controllable beat frequency between 0-250 Hz. (Megan Medical, Inc.)

Blog Describes Obstructive Sleep Apnea Device Under Development

March 27, 2015 - A Belgium-based business pursuing neuromodulation applications, Nyxoah, was featured in a blog by the Health Cluster of Wallonia. The 20-person, clinical-stage company has R&D facilities in Israel and is developing an implant to treat obstructive sleep apnea that is wirelessly powered by an adhesive patch and activation chip worn at night. (Win Health)

Company With Novel Implanted Stimulator for Pain Plans to Add Staff

March 18, 2015 - Stimwave Technologies of Miami Beach, FL announced plans to double in size by hiring 20 staff members, primarily for clinical support, over the coming year, and plans to move to Fort Lauderdale in May. The company relocated to Florida about a year ago from Arizona in order to be in a location that is central to customers in the U.S., Central America and Europe. The company has a 12-cm Freedom Stimulator for spinal cord stimulation to treat chronic pain, and plans to release a peripheral nerve stimulator later this year. (South Florida Business Journal)

Company Eyes Overactive Bladder Application, and Is Expanding to Germany

Feb. 27, 2015 - nUro, Inc. is adapting its CE Marked Synapse™ system to a wireless neurostimulation system for the treatment of overactive bladder. The company plans to begin trading on the US OTC Markets QB Stock Exchange by Aug. 1, 2015. It is opening a German subsidiary in the Erlangen Medical Valley Center, and plans to also begin trading in 2015 on a German stock exchange. (PR Web)

Company Receives CE Mark for Vagus Nerve Stimulation System in Heart Failure

Feb. 26, 2015 - Cyberonics, Inc. announced it has received CE mark approval of its vagus nerve stimulation for use as adjunctive therapy in treatment-resistant patients with heart failure with left ventricular dysfunction. The company's Vitaria system delivers autonomic regulation therapy, which was shown in the open-label ANTHEM-HF clinical study to improve a number of symptoms at six months of treatment. (

Neuromodulation Company to Merge with Global Device Company

Feb. 26, 2015 - Cyberonics Inc. plans to merge with create a new company domiciled in the UK by buying* Italian medical device company Sorin SpA in an all-stock deal to create a new company with a combined equity of $2.7 billion. The new company will apply for dual-listing on the Nasdaq and the London Stock Exchange, the companies said in a statement. The newly formed company will include a portfolio addressing heart failure and sleep apnea, according to a news release by Sorin Group. *Note: Reuters later ran an updated story to clarify that this is a merger. (Reuters)

Neuromodulation Supplier Reports Increased Earnings

Feb. 25, 2015 - Greatbatch Inc. reported adjusted earnings per share of 65 cents in the fourth quarter of 2014, up 18.2% from one year ago. Revenues from QiG Group, which includes sales from the recently acquired implantable-pulse-generator-maker CCC Medical Devices, rose to $5.5 million from $0.9 million the previous year. (Nasdaq)

Insurer Adds Coverage of Overactive Bladder Treatment

Feb. 24, 2015 - Uroplasty, Inc. announced its percutaneous tibial nerve stimulation therapy for overactive bladder is now covered by Cigna, which wrote a positive coverage policy that applies to some 14 million people and became effective Feb. 15, 2015. (CNN Money)

Peripheral Nerve Stimulation Device Receives FDA Clearance

Feb. 24, 2015 - Bioness, Inc. announced FDA clearance of its minimally invasive neuromodulation device for peripheral nerve pain, StimRouter®, which consists of an implanted lead, external pulse transmitter and conductive electrode, and is controlled by a small hand-held wireless control unit. Electrical signals travel from the pulse generator to the electrode and down the lead to the origin of pain. (Business Wire)

Obesity Device Startup Announces Fourth Quarter Earnings

Feb. 23, 2015 - An earnings report for EnteroMedics, Inc., whose vagus nerve stimulation therapy for certain types of obesity received FDA approval in January, shows that as the company completed U.S. regulatory approval and geared up for commercialization, its losses totaled nearly $6.2 million in the fourth quarter of 2014. The loss of $0.09 per basic and diluted share was a slight improvement losses in the same quarter a year ago of $0.11 per basic/diluted share. For the year, EnteroMedics lost $26.1 million, and had $11.6 million on hand. (Mass Device)

Company Developing Closed-Loop Spinal Cord Stimulation Announces $10 Million Investment

Feb. 23, 2015 - Saluda Medical announced it received $10 million in Series B financing in a funding round led by new investor Biosciences Managers, in which existing investors also participated. The Australian-based company plans to use the funds to support clinical trials and commercialization plans for its Evoke™ closed-loop spinal cord stimulation system that is intended to treat chronic pain of the trunk and limbs, automatically adjusting stimulation levels for optimal pain relief. (Send2Press Newswire)

Company Acquires Developer of Overactive Bladder Treatment

Feb. 23, 2015 - Medtronic plc has acquired Advanced Uro-Solutions, a Tennessee-based developer of a percutaneous tibial nerve stimulation system, which consists of a small external stimulator and a single, reusable lead to provide temporary stimulation to the tibial nerve, NURO(TM). The device has FDA clearance for patients with overactive bladder and associated symptoms, and Medtronic plans U.S. commercialization within the next 12 months. (Fierce Medical Devices)

Business Profile Features Borough's Neuromodulation Center

Feb. 8, 2015 - A business feature profiles the Greenville Neuromodulation Center, which opened 10 years ago in Greenville, a borough of about 5,000 people, 80 miles from Pittsburgh and Cleveland, which is home to Thiel College. Eighteen months ago the center added a neurologist experienced in deep brain stimulation. (Sharon Herald)

Spinal Cord Stimulation System Receives Expanded Labeling for MRI Scans

Feb. 4, 2015 -  Nevro Corp. announced its Senza® spinal cord stimulation system has received approval for expanded labeling in Europe and Australia. The expanded labeling now permits scans of the head and extremities with both 1.5 and 3 Tesla MRI machines under specified conditions for existing and future patients. (Market Watch)

Company Plans a U.S. Clinical Trial of Its Neurostimulation Device to Treat Chronic Lower Back Pain

Jan. 26, 2015 - Mainstay Medical International plc has applied for an FDA Investigational Device Exemption to begin a clinical trial of its ReActiv8® implantable neurostimulation device to treat people with disabling chronic low back pain for whom conventional therapy has not been successful and for whom surgery is not indicated. (Mainstay Medical)

Company Announces FDA Allows Gastroparesis Device Therapy

Jan. 23, 2015 - Medtronic announced a Humanitarian Device Exemption for its Enterra II neurostimulation implant for treating gastroparesis. (Mass Device)

Price Index Tracks Hospital Costs for Spinal Cord Stimulators

Jan. 23, 2015 - According to the Modern Healthcare/ECRI Institute Technology Price Index, the average cost of spinal cord stimulators is now $16,957, up 8% from this time last year. The article mentions that advanced versions released in 2013 by Boston Scientific Corp. and Medtronic cost on average $19,000 while older models cost hospitals on average $13,000, although more hospitals are choosing to buy the newer devices. (Modern Healthcare)

Company Plans to Release Cochlear Implant on U.S. Market That Permits 3.0 Tesla Imaging

Jan. 23, 2015 - MED-EL USA says it will launch its Synchrony cochlear implant in the U.S. following FDA approval for this model, which the company says is the only U.S.-approved one that can be used with 3.0 Tesla magnetic resonance imaging devices without surgical removal of the internal magnet. (FDA News)

Company Announces FDA "Approvability" Letter for New Spinal Cord Stimulator

Jan. 22, 2015 - Nevro Corp. announced the FDA has written to say that, subject to check-off on a number of inspection, audit, labeling, and similar compliance issues, its Senza spinal cord stimulation system is approvable under the premarket approval application, based on the application's supporting data. (PR Newswire)

FDA Approves Intrathecal Device With Safety Valve to Facilitate MRI Procedures

Jan. 19, 2015 - Flownix Medical Inc. announced a PMA-Supplement approval from the FDA for is intrathecal Prometra® II system with a flow-activated safety valve that allows an MRI without the need to remove the drug from the reservoir in advance. (PR Newswire)

Shareholders Pave Way for Merger to Close

Jan. 7, 2015 - Medtronic, Inc. said shareholders who have more than 75% of the stock voted in favor of its merger with Ireland-based Covidien, whose shareholders approved the deal hours earlier. The $43 billion merger should close in two weeks, turning Medtronic into an Irish-based entity, Medtronic PLC. (Mass Device)

Cross-Continental Merger Faces Shareholder Vote Tomorrow

Jan. 4, 2015 - After a shareholder vote tomorrow on the $48 billion merger of Medtronic, Inc. and Covidien, an article in the Minneapolis Star Tribune says, Medtronic would become a new Irish-domiciled, multinational conglomerate called Medtronic PLC. Top executives will remain based in Fridley, MN. The New York Stock Exchange ticker will remain MDT, with the new shares expected to begin trading at the same price as the closing price from the day before. (Star Tribune)

Archived Industry News


Last Updated on Wednesday, March 13, 2019 03:57 PM