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ElectroCore raises $36m, looks to raise $29m more
ElectroCore has raised $36 million in a new round of equity and options financing, according to an SEC filing posted this week. The Basking Ridge, N.J.-based company is seeking an additional $29 million in the round to bring the total to $65 million. Funds raised so far have come from 31 unnamed investors, with the 1st sale dated on August 21, according to the SEC filing. Electrocore developed and produces the gammaCore non-invasive vagus nerve stimulator. The device won FDA approval in April and was launched in mid-July with indications for treating pain associated with episodic cluster headaches in adult patients. In Jun...
Source: Mass Device - September 8, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neuromodulation/Neurostimulation electroCore Source Type: news

LivaNova shares rise on Q2 beat
Shares in LivaNova (NSDQ:LIVN) rose today after the medical device maker beat expectations on Wall Street with its 2nd quarter earnings results. The London-based company posted profits of $47.5 million, or 98¢ per share, on sales of $321.4 million for the 3 months ended June 30, seeing massive bottom-line growth of 427.8% while sales grew a smaller 0.1% compared with the same period last year. Adjusted to exclude 1-time items, earnings per share were $1.01, well ahead of the 82¢ consensus on Wall Street, where analysts were expecting to see sales of $315.6 million, which LivaNova topped. “We made progr...
Source: Mass Device - August 9, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat LivaNova Source Type: news

LivaNova wins CMS NTAP reimbursement for Perceval aortic valve
LivaNova (NSDQ:LIVN) said today that its Perceval sutureless aortic heart valve replacement won approval from the Centers for Medicare and Medicaid Services for a New Technology Add-On Payment. The London-based company said that the Perceval valve had met the CMS criteria for the add-on payment, including showing substantial clinical improvement over existing technologies. With the reimbursement approval, CMS will begin to reimburse hospitals for the Perceval valve procedure with the normal Medicare Severeity Diagnosis Related Group payment as well as an additional $6,110.23, LivaNova said. “We are pleased ...
Source: Mass Device - August 4, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves Centers for Medicare and Medicaid Services (CMS) LivaNova Source Type: news

LivaNova wins MRI-safe CE Mark for VNS Therapy systems
LivaNova (NSDQ:LIVN) said today it won expanded CE Mark approval in the European Union for its Vagus Nerve Stimulation Therapy systems, now labeled as safe for 1.5T and 3T magnetic resonance imaging scans. The labeling change for the London-based medical device maker includes its AspireHC and AspireSR devices, allowing patients with existing devices to safely have MRI scans without the need for special equipment. “In addition to offering patients more seizure-free moments, we can now better support comprehensive epilepsy treatment throughout a patient’s lifetime,” neuromodulation biz GM Jason Ri...
Source: Mass Device - August 1, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neuromodulation/Neurostimulation Regulatory/Compliance LivaNova Source Type: news

ElectroCore launches gammaCore handheld VNS in US
Neuroscience tech developer ElectroCore said today it launched its gammaCore non-invasive vagus nerve stimulator, designed for the acute treatment of pain associated with episodic cluster headaches in adult patients, in the US. The Basking Ridge, N.J.-based company touted the device as the 1st non-invasive, hand-held vagus nerve stimulation device for the reduction of pain. The system is designed to be applied to the neck and applies a patented electrical stimulation through the skin to activate the vagus nerve. “We are proud to bring gammaCore to the U.S. market, as it provides episodic cluster headache suffere...
Source: Mass Device - July 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neuromodulation/Neurostimulation electroCore Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 30, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. LivaNova wins FDA nod for VNS therapy neurostim for young epilepsy patients LivaNova said today it won FDA approval of its Vagus Nerve Stimulation Therapy system for patients as young as 4 years of age with partial onset seizur...
Source: Mass Device - June 30, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Improving VNS therapy: ElectroCore CEO Amato on gammaCore and its slated July launch
Neuroscience tech developer ElectroCore said recently it plans to launch its handheld gammaCore vagus nerve stimulation device in the US in mid-July, after having won clearance from the FDA in April for treating episodic cluster headaches. Unlike other vagus nerve stimulation devices, the gammaCore is an external handheld device with no implanted component, designed to be used in a pain-free procedure, CEO Frank Amato told MassDevice.com in an interview. “Its a first-of-its-kind type of device,” Amato said, speaking on the recently approved and soon-to-launch gammaCore. “Vagus nerve stimulators have been ...
Source: Mass Device - June 30, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neuromodulation/Neurostimulation Pain Management Source Type: news

FDA Okays VNS for Epilepsy in Children as Young as 4 Years FDA Okays VNS for Epilepsy in Children as Young as 4 Years
VNS therapy is indicated as an adjunctive therapy to reduce the frequency of seizures in children with partial-onset seizures refractory to antiepileptic medications.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 30, 2017 Category: Consumer Health News Tags: Neurology & Neurosurgery News Alert Source Type: news

LivaNova wins FDA nod for VNS therapy neurostim for young epilepsy patients
LivaNova (NSDQ:LIVN) said today it won FDA approval of its Vagus Nerve Stimulation Therapy system for patients as young as 4 years of age with partial onset seizures that are refractory to antiepileptic medications. The London-based company touted that with the clearance, its VNS Therapy system is the only FDA-approved device for drug-resistant epilepsy in the pediatric population. Previously, the device was only approved for patients ages 12 and older. “Epilepsy affects one in 26 Americans, and 35% of these patients fail to respond to medications. VNS Therapy offers many of these patients a chance for impr...
Source: Mass Device - June 29, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance LivaNova Source Type: news

Medical News Today: What is the vagus nerve?
In this article, learn about the vagus nerve and what it affects in the body. What is vagus nerve stimulation and what further research is being conducted? (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - June 28, 2017 Category: Consumer Health News Tags: Neurology / Neuroscience Source Type: news

LivaNova wins expanded MR indication for VNS Therapy device
LivaNova (NSDQ:LIVN) said today it won FDA approval for expanded MRI labeling for its Vagus Nerve Stimulation Therapy device, touting it as the only epilepsy device cleared by the FDA for MRI scans. With the approval, patients with the minimally invasive VNS system are cleared to visit any MRI center in the US, with access to more than 90% of routine scans for patients with epilepsy, the London-based company said. “The FDA’s approval to expand our MRI labeling changes the landscape for device-based epilepsy therapies. This further differentiates our technology from other epilepsy treatment options and adds...
Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance Source Type: news

ElectroCore touts gammaCore cluster headache trial data
Neuroscience tech developer ElectroCore today released data from the ACT clinical trials exploring the use of its gammaCore non-invasive vagus nerve stimulator for treating patients with episodic cluster headaches. Results from the study were presented at the 59th Annual Scientific Meeting of the American Headache Society, the company said. The 250-patient studies evaluated the safety and efficacy of the gammaCore device as an acute treatment for patients with cluster headaches, the company said. Data from the trial indicated that the proportion for patients who achieved mild or no pain at 15 minutes po...
Source: Mass Device - June 8, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Pain Management electroCore Source Type: news

Here ’s how vagus nerve stimulation is getting better
A vagus nerve implant with 2 electrodes – one to apply desired stimulation going down into the body, the other to block unwanted stimulation going up to the brain. [Image from Georgia Tech/Rob Felt]Georgia Institute of Technology researchers have reported success targeting vagus nerve stimulation – providing hope for people with a host of inflammatory diseases including rheumatoid arthritis, irritable bowel syndrome and Crohn’s disease. Researchers implanted a pacemaker-like device into rats and showed that it could electrically stimulate the vagus nerve while simultaneously preventing unwanted nerve acti...
Source: Mass Device - June 8, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Implants Research & Development Georgia Institute of Technology MedTech stimulation vagus nerve Source Type: news

FDA Approves Vagus Stimulation Device for Cluster Headache FDA Approves Vagus Stimulation Device for Cluster Headache
The FDA has approved a noninvasive vagus nerve stimulation device for the treatment of pain from cluster headache in adults.FDA Approvals (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - April 18, 2017 Category: Neurology Tags: Neurology & Neurosurgery News Alert Source Type: news

FDA clears ElectroCore ’ s GammaCore cluster headache treatment
Neuroscience tech developer ElectroCore said today it won FDA clearance for its GammaCore non-invasive vagus nerve stimulator designed to treat pain associated with episodic cluster headaches. The GammaCore device is designed to transmit a mild electrical stimulation to the vagus nerve through the skin to reduce pain, the Basking Ridge, N.J.-based company said.  The device is the company’s 1st to win FDA clearance. “The U.S. release of gammaCore for the acute treatment of pain associated with episodic cluster headache in adult patients is a major milestone for electroCore, as it not only marks electro...
Source: Mass Device - April 18, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Pain Management Regulatory/Compliance electroCore Source Type: news

FDA Releases gammaCore(R), the First Non-Invasive Vagus Nerve Stimulation Therapy Applied at the Neck for Acute Treatment of Pain Associated with Episodic Cluster Headache in Adult Patients
First U.S. Food and Drug Administration (FDA) release for electroCore, a neuroscience and technology company Hand-held, non-invasive, easy-to-use device provides new option for the approximately 400,000 Americans living with this rare but extremely debi... Devices, FDA electroCore, gammaCore, vagus nerve stimulation, cluster headache (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 18, 2017 Category: Pharmaceuticals Source Type: news

Potential way to reduce drug cravings: Vagus nerve stimulation therapy
A new preclinical study shows that vagus nerve stimulation therapy might have the potential to help people overcome drug addiction by helping them learn new behaviors to replace those associated with seeking drugs. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - January 23, 2017 Category: Science Source Type: news

Researcher finds potential way to reduce drug cravings
(University of Texas at Dallas) A new preclinical study led by a University of Texas at Dallas researcher shows that vagus nerve stimulation therapy might have the potential to help people overcome drug addiction by helping them learn new behaviors to replace those associated with seeking drugs. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 23, 2017 Category: Global & Universal Source Type: news

Buzzing the vagus nerve just right to fight inflammatory disease
Electrical vagus nerve stimulation can help fight inflammatory diseases like Crohn's or arthritis but can also contribute somewhat to inflammation. Engineers have tweaked the buzz to keep the good effects and minimize those less desirable. Their innovation could be adapted to existing medical devices with relative ease. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - January 5, 2017 Category: Science Source Type: news

Buzzing the vagus nerve just right to fight inflammatory disease
(Georgia Institute of Technology) Electrical vagus nerve stimulation can help fight inflammatory diseases like Crohn's or arthritis but can also contribute somewhat to inflammation. Engineers have tweaked the buzz to keep the good effects and minimize those less desirable. Their innovation could be adapted to existing medical devices with relative ease. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 5, 2017 Category: Global & Universal Source Type: news

LivaNova shares tumble on CEO exit, Q3 earnings report
LivaNova (NSDQ:LIVN) shares slid nearly 15% today after the company announced the resignation of CEO André-Michel Ballester and released its 3rd quarter earnings. The London-based company said its current CEO Ballester will resign effective December 31 this year, to be replaced by current COO Damien McDonald. Ballester served as CEO at Sorin from 2007 to 2015, up to the merger that created LivaNova when the company joined with Cyberonics, the company said. “On behalf of the LivaNova board of directors, I would like to thank André-Michel for his highly successful 12-year career with LivaNova and Sor...
Source: Mass Device - November 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News LivaNova Source Type: news

Effects of brisk walking on autonomic nervous system reactivation in nursing home residents. Additional effects of transcutaneous vagus nerve stimulation - Raffin J, Barth élémy JC, Terrat P, Diana MC, Achour É, Calmels P, Oriol M, Busso T, Hammadi L, Montuy-Coquard C, Bouvier R, Poillerat R, Roche F, Hupin D.
OBJECTIVE: It is well established that physical activity reduces the physiological effects of ageing. Among them, is the decrease of the autonomic nervous system (ANS) activity, which is associated with the increase of cardiovascular events and morbidities... (Source: SafetyLit)
Source: SafetyLit - October 1, 2016 Category: Global & Universal Tags: Age: Elder Adults Source Type: news

ElectroCore raises $1.5m
ElectroCore raised $1.5 million in a new round of debt financing, according to an SEC filing posted today. ElectroCore is developing a range of non-invasive vagus nerve stimulation for the treatment of a number of conditions in neurology, psychiatry, gastroenterology and other fields, according to the company’s website. Initial focus for the company is a non-invasive, self-administered vagus nerve stimulation treatment for headaches. The nVNS procedure is designed to treat migraine and cluster headaches, and has CE Mark approval in the European Union. Money in the round so far has come from a single anonymous in...
Source: Mass Device - August 8, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Neurological Neuromodulation/Neurostimulation Pain Management electroCore Source Type: news

Noninvasive VNS Promising in Chronic Migraine Prevention Noninvasive VNS Promising in Chronic Migraine Prevention
Pilot results show a noninvasive vagus nerve stimulation device was safe and well tolerated, and it may reduce headache days in chronic migraine. Medscape Medical News (Source: Medscape Pathology Headlines)
Source: Medscape Pathology Headlines - July 22, 2016 Category: Pathology Tags: Neurology & Neurosurgery News Source Type: news

Your NEJM Group Today: Milk of Urate Bulla Images, Vagus Nerve Stimulation, Washington State FM Opportunity (FREE)
By the Editors NEJM Group offers so many valuable resources for practicing clinicians. Here's what we chose for you today:NEJM Clinical Practice Center: Images in Clinical … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - July 19, 2016 Category: Primary Care Source Type: news

Vagus nerve stimulation may help reduce rheumatoid arthritis symptoms
Stephen FellerWASHINGTON, July 5 (UPI) -- Implanting a device to stimulate the vagus nerve helped rheumatoid arthritis patients improve significantly, according to a recent study. (Source: Health News - UPI.com)
Source: Health News - UPI.com - July 5, 2016 Category: Consumer Health News Source Type: news

Nerve stimulation device 'can offer relief from rheumatoid arthritis symptoms'
This study is interesting and shows promising results that explore the link between the nervous system and inflammation in rheumatoid arthritis. This link is significant, as it could indicate the potential for alternative treatments for inflammatory conditions. However, the sample size is small, so more research is needed into the long-term effects of this intervention."Rheumatoid arthritis is a painful and debilitating condition that has a huge impact on more than 400,000 people within the UK. We now understand far more about the process of inflammation, and this understanding has led to new and better forms of treat...
Source: Arthritis Research UK - July 4, 2016 Category: Rheumatology Source Type: news

Study shows vagus nerve stimulation significantly reduces rheumatoid arthritis symptoms
(Northwell Health) Clinical trial data published in the Proceedings of the National Academy of Sciences (PNAS) demonstrates stimulating the vagus nerve with an implantable bioelectronic device significantly improved measures of disease activity in patients with rheumatoid arthritis (RA). (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 4, 2016 Category: Global & Universal Source Type: news

SUDEP Rate Lower in Epilepsy Patients After VNSSUDEP Rate Lower in Epilepsy Patients After VNS
A new large observational study increases the power of previous studies by 100-fold and suggests patients with drug-resistant epilepsy treated with vagus nerve stimulation have a reduced risk of sudden death. Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - May 30, 2016 Category: Neurology Tags: Neurology & Neurosurgery News Source Type: news

NICE Provides Positive Guidance on electroCore's gammaCore Treatment for the Prevention and Acute Treatment of Migraine and Cluster Headache
BASKING RIDGE, New Jersey, April 1, 2016 -- (Healthcare Sales & Marketing Network) -- The UK's National Institute of Health and Care Excellence (NICE) has published guidance that electroCore's non-invasive vagus nerve stimulation treatment (gammaCore) for... Devices, Neurology, RegulatoryelectroCore, gammaCore, vagus nerve stimulation, migraine (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 1, 2016 Category: Pharmaceuticals Source Type: news

New non-invasive form of vagus nerve stimulation works to treat depression
Depression can be a devastating and unremitting problem. Researchers now report successful reduction of depressive symptoms in patients using a novel non-invasive method of vagus nerve stimulation, or VNS. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - February 4, 2016 Category: Science Source Type: news

Medtech approvals: FDA releases December 2015 PMAs
The Food & Drug Administration today released a list of pre-market approvals granted in December 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 81 Summary of PMA Originals Under Review Total Under Review: 58 Total Active: 32 Total On Hold: 26 Summary of PMA Supplements Under Review Total Under Review: 599 Total Active: 423 Total On Hold: 176 Summary of All PMA Submissions Originals: 3 Supplements: 92 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 81 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 163.1 FDA Time: 140....
Source: Mass Device - February 2, 2016 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Medtech approvals: FDA releases November 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in November 2015: Summary of PMA Originals & Supplements Approved Originals: 3 Supplements: 69 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 30 Total On Hold: 27 Summary of PMA Supplements Under Review Total Under Review: 583 Total Active: 433 Total On Hold: 150 Summary of All PMA Submissions Originals: 4 Supplements: 75 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 69 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 193.4 FDA Tim...
Source: Mass Device - January 22, 2016 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Vagus nerve stimulation shows progress in stroke patient recovery
Vagus nerve stimulation (VNS) technology could help improve the lives of hundreds of thousands of people who suffer weakness and paralysis caused by strokes, new research suggests. The study marks the first time that VNS has been tested in individuals recovering from stroke. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - December 9, 2015 Category: Science Source Type: news

Medtech approvals: FDA releases October 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in October 2015: Summary of PMA Originals & Supplements Approved Originals: 9 Supplements: 133 Summary of PMA Originals Under Review Total Under Review: 58 Total Active: 32 Total On Hold: 26 Summary of PMA Supplements Under Review Total Under Review: 597 Total Active: 433 Total On Hold: 164 Summary of All PMA Submissions Originals: 7 Supplements: 74 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 133 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 161.5 FDA Ti...
Source: Mass Device - December 4, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

UT Dallas researchers use vagus nerve stimulation outside the forebrain
(University of Texas at Dallas) Dr. Patrick Ganzer of the Texas Biomedical Device Center won a best paper award for work that uses vagus nerve stimulation paired with rehabilitation to enhance neuroplasticity. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - November 17, 2015 Category: Biology Source Type: news

NeuroSigma wins CE Mark for eTNS ADHD system
NeuroSigma Systems said today it won CE Mark approval in the European Union for its Monarch eTNS system to treat attention-deficit/hyperactivity disorder in adults and children 7 and older. Los Angeles-based NeuroSigma said it is the 1st and only non-drug treatment for ADHD approved in the European Union. “ADHD is estimated to affect up to 9.5% of school age children and 4.4% of adults, and many people have concerns about using stimulant medications.  In research conducted at the University of California, Los Angeles, eTNS was well accepted by children and their parents, and produced significant improv...
Source: Mass Device - November 17, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Neurological Regulatory/Compliance NeuroSigma Inc Source Type: news

Medtech approvals: FDA releases September 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in September 2015: Summary of PMA Originals & Supplements Approved Originals: 4 Supplements: 53 Summary of PMA Originals Under Review Total Under Review: 55 Total Active: 31 Total On Hold: 24 Summary of PMA Supplements Under Review Total Under Review: 611 Total Active: 461 Total On Hold: 150 Summary of All PMA Submissions Originals: 3 Supplements: 84 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 53 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 127.6 FDA Ti...
Source: Mass Device - November 16, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 70 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 28 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 569 Total Active: 422 Total On Hold: 147 Summary of All PMA Submissions Originals: 5 Supplements: 90 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 70 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 229.0 FDA Time:...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news

Epilepsy device developer NeuroSigma withdraws IPO
UCLA-spun out NeuroSigma Systems withdrew its plans for an initial public offering that could have brought the company as much as $50 million for its noninvasive system to treat drug-resistant epilepsy. NeuroSigma is developing the Monarch eTNS system, which delivers mild electrical signals through a forehead patch to stimulate branches of the trigeminal nerve. The Los Angeles-based company is marketing the device as an alternative to vagus nerve stimulation and deep-brain stimulation, both of which require surgical implants. NeuroSigma is also developing a subcutaneous, implantable version of the system. Last August ...
Source: Mass Device - September 28, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Initial Public Offering (IPO) Neurological NeuroSigma Source Type: news

Medtech approvals: FDA releases June 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in June 2015: Summary of PMA Originals & Supplements Approved Originals: 5 Supplements: 80 Summary of PMA Originals Under Review Total Under Review: 53 Total Active: 22 Total On Hold: 31 Summary of PMA Supplements Under Review Total Under Review: 575 Total Active: 418 Total On Hold: 157 Summary of All PMA Submissions Originals: 4 Supplements: 72 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 80 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 115.2 FDA Time: 9...
Source: Mass Device - August 20, 2015 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

The antidepressant-like effect of vagus nerve stimulation is mediated through the locus coeruleus - Grimonprez A, Raedt R, Portelli J, Dauwe I, Larsen LE, Bouckaert C, Delbeke J, Carrette E, Meurs A, De Herdt V, Boon P, Vonck K.
It has been shown that vagus nerve stimulation (VNS) has an antidepressant-like effect in the forced swim test. The mechanism of action underlying this effect is incompletely understood, but there is evidence suggesting that the locus coeruleus (LC) may pl... (Source: SafetyLit: All (Unduplicated))
Source: SafetyLit: All (Unduplicated) - August 15, 2015 Category: Global & Universal Tags: Ergonomics, Human Factors, Anthropometrics, Physiology Source Type: news

Vagal Stimulation May Help Upper Limb Stroke Recovery
Patients with upper limbs affected by ischemic stroke who paired traditional rehabilitation exercises with pulsed vagus nerve stimulation boosted functional scores significantly higher than did those who performed exercises alone in a small, randomized pilot trial. (Source: Caring for the Ages)
Source: Caring for the Ages - August 1, 2015 Category: Health Management Authors: Michele G. Sullivan Source Type: news

Cyberonics wins FDA nod for AspireSR
Cyberonics (NSDQ:CYBX) said it won FDA approval for its AspireSR generator designed for vagus nerve stimulation to treat drug-resistant epilepsy. VNS is approved by the FDA to treat epilepsy by delivering electrical signals to the vagus nerve, which project to areas of the brain associated with seizures. Studies have shown a majority of drug-resistent epileptic […] The post Cyberonics wins FDA nod for AspireSR appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 2, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) mm Neurological Regulatory/Compliance AspireSR Epilepsy Source Type: news

Vagus Nerve Stimulation Suppresses Atrial FibrillationVagus Nerve Stimulation Suppresses Atrial Fibrillation
Will autonomic neuromodulation emerge as an alternative nonpharmacological, nonablative modality to treat paroxysmal AF? Journal of the American College of Cardiology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 3, 2015 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Vagus Nerve Stimulator and Epilepsy
Vagus nerve stimulation is a procedure that stimulates a person's vagus nerve with electrical impulses. Vagus nerve stimulation (VNS) may be used to treat epilepsy when other types of treatments have failed to work. VNS is also used to treat depression and it is being studied for conditions such as migraines, Multiple Sclerosis and Alzheimer's disease. There is one vagus nerve on each side of a person's body; they run from the brainstem through a person's neck to their chest and abdomen. (Source: Disabled World)
Source: Disabled World - January 28, 2015 Category: Disability Tags: Epilepsy Source Type: news

An autopsy case of vagus nerve stimulation following acupuncture - Watanabe M, Unuma K, Fujii Y, Noritake K, Uemura K.
Acupuncture is one of the most popular oriental medical techniques in China, Korea and Japan. This technique is also popular as alternative therapy in the Western World. Serious adverse events are rare following acupuncture, and fatal cases have been rarel... (Source: SafetyLit: All (Unduplicated))
Source: SafetyLit: All (Unduplicated) - December 11, 2014 Category: Global & Universal Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Cyberonics Reports Consistently Positive Results From The E-36 And E-37 Studies For VNS Therapy Delivered By AspireSR(R) Generator
New Results Presented at the 68th American Epilepsy Society (AES) Annual Meeting HOUSTON, Dec. 8, 2014 -- (Healthcare Sales & Marketing Network) -- Cyberonics, Inc. (CYBX), maker of the VNS Therapy® System implanted in more than 80,000 patients, an... Devices, NeurologyCyberonics, AspireSR, VNS Therapy System (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 8, 2014 Category: Pharmaceuticals Source Type: news

Neuroprotective effects of vagus nerve stimulation on traumatic brain injury - Zhou L, Lin J, Lin J, Kui G, Zhang J, Yu Y.
Previous studies have shown that vagus nerve stimulation can improve the prognosis of traumatic brain injury. The aim of this study was to elucidate the mechanism of the neuroprotective effects of vagus nerve stimulation in rabbits with brain explosive inj... (Source: SafetyLit: All (Unduplicated))
Source: SafetyLit: All (Unduplicated) - November 9, 2014 Category: Global & Universal Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Noninvasive Vagus Nerve Stimulation Slows Cluster HeadacheNoninvasive Vagus Nerve Stimulation Slows Cluster Headache
The neurostimulation device produced reductions in headache frequency, and the need for rescue medication for chronic cluster headache. Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - October 30, 2014 Category: Neurology Tags: Neurology & Neurosurgery News Source Type: news