MedAutonomic said today it has successfully implanted a brain neuromodulation device, the Phoenix, into the stomach wall of a human through an innovative digestive endoscopic procedure. Powered without a battery, the Phoenix sends signals to the limbic system to reset an imbalance in the autonomic nervous system to treat metabolic syndrome and functional diseases […]
LivaNova launches pivotal study for Vitaria heart failure device
LivaNova (NSDQ:LIVN) said today that it launched a pivotal study of its Vitaria neuromodulation implant for treating heart failure. The 800-patient Anthem-HFrEF study’s first subject was implanted with the Vitaria vagus nerve stimulation device at St. Luke’s Hospital in Cedar Rapids, Iowa, the London-based company said. Patients enrolled in the trial are slated to be randomized on […]
GE, DARPA are taking on Type 2 diabetes with electricity
GE and DARPA are collaborating on a $2.9 million study of neuromodulation as a treatment for Type 2 diabetes. GE scientists have developed a novel, potentially breakthrough approach that could restore nerve signals to a healthy state using non-invasive devices that stimulate metabolic biosystems and produce drug-like effects, but with greater precision than traditional treatments, […]
Abbott wins Aetna nod for Proclaim neurostim in chronic pain
Abbott (NYSE:ABT) said today that it won a reimbursement nod from Aetna (NYSE:AET) for its Proclaim dorsal root ganglion neurostimulation therapy for treating chronic pain. The national coverage decision opens DRG treatment to some 22 million Aetna members, Abbott said. Aetna already covers treatment with Abbott’s spinal cord stimulation devices, the company said. It acquired […]
BlueWind posts positive follow-up study results
Neurostim developer BlueWind Medical reported positive results from a follow-up study of patients using its implantable tibial nerve stimulator for overactive bladder (OAB). Renova iStim is a leadless, miniature, wireless neurostimulation platform designed for the treatment of multiple clinical indications. Three years after implantation of the BlueWind’s Renova iStim device, 75% of patients experienced at least a 50% […]
LivaNova launches global study of epilepsy treatment
The first patient with drug-resistant epilepsy has received LivaNova’s (NASDAQ:LIVN) vagus nerve stimulation (VNS) therapy system, kicking off enrollment of a global registry to evaluate it, the company said. Drug-resistant epilepsy (DRE) affects nearly one in three people with epilepsy, according to an article in the New England Journal of Medicine. The LivaNova study will […]
BrainsWay wins ‘historic milestone’ clearance to treat OCD
BrainsWay said it has won de novo clearance from the FDA for its deep transcranial magnetic stimulation (Deep TMS) system for treatment of obsessive-compulsive disorder (OCD) in adults. The clearance marks the second indication granted for BrainsWay Deep TMS, and the first noninvasive medical device clearance for the treatment of OCD. The FDA cleared the device […]
Brainsway wins FDA nod for OCD-treating TMS system
The FDA today said it granted de novo approval for Brainsway‘s deep transcranial magnetic stimulation system, now indicated for treating obsessive compulsive disorder. The TMS system uses magnetic fields to simulate nerves in the brain, and has been shown to reduce the severity of OCD in patients. A 100-patient randomized, multi-center study of the device […]
SPR Therapeutics’ new PNS system wins FDA nod
The FDA has approved SPR Therapeutics’ (Cleveland) Sprint endura (single lead) and extensa (dual lead) peripheral nerve stimulation (PNS) systems. The minimally invasive Sprint system is the only FDA-approved percutaneous PNS system that is indicated for up to 60 days in the back and/or extremities for both chronic and acute pain and is the industry’s only dual lead […]
ElectroCore inks nVNS neuroinflammatory response research deal with MGH
ElectroCore said yesterday it inked a collaborative research deal with Massachusetts General Hospital exploring the use of ElectroCore’s non-invasive vagus nerve stimulation tech in targeted treatments for neuroinflammation. The Basking Ridge, N.J.-based company said that investigators will examine the effects the nVNS system has on neuroinflammatory mechanisms associated with conditions in the central nervous system including […]
Nevro’s Q2 losses exceed expectations
Although it pared its second-quarter losses on strong revenue growth, Nevro Corp. (NYSE:NVRO) missed the consensus earnings forecast yesterday due to increased labor costs and a legal battle with spinal cord stimulation rival Boston Scientific (NYSE:BSX). Redwood City, Calif.-based Nevro posted losses of -$10.7 million, or -35¢ per share, on sales of $96.1 million for the three […]
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