Abbott (NYSE:ABT) said today that it inked a partnership deal with the National Institutes of Health to support the Brain Research through Advancing Innovative Neurotechnologies, or BRAIN initiative. The NIH’s BRAIN initiative aims to accelerate neuroscience research and advancements, Chicago-area based Abbott said. Through the partnership, Abbott will provide its neuromodulation tech, including directional deep brain […]
Omron joins $35m Theranica Series B
Theranica said today that Omron Healthcare‘s (TYO:6645) Omron Ventures arm joined a $35 million Series B financing round to support its remote neuromodulation technology. Israel-based Theranica is developing the Nerivio Migra neurostimulation patch intended to treat migraine headache, which is currently under FDA review. Funding in the round, which was initially announced in March, was […]
HRS 2019: Parasym ear stim device shows promise in AFib
Noninvasive neurostimulation of the ear shows promise when it comes to treating atrial fibrillation, according to clinical study results presented today at the Heart Rhythm Society’s annual scientific sessions, held in San Francisco. University of Oklahoma researchers over a six-month period studied the effects of London-based Parasym‘s noninvasive neurostimulation device on roughly 50 paroxysmal AFib […]
NeuroSigma wins FDA nod for ADHD device
UPDATED April 24, 2019, with comment from NeuroSigma. NeuroSigma won de novo clearance from the FDA last week to put the first medical device for treating attention-deficit hyperactivity disorder on the U.S. market. Los Angeles-based NeuroSigma makes the Monarch eTNS system, which is designed to deliver mild electrical signals through a forehead patch to stimulate […]
Brainsway prices downsized $28m IPO
Brainsway yesterday priced its initial public offering in the U.S. slightly below the terms it set earlier this month. The Jerusalem-based company, which is already publicly traded in Israel, said April 3 that it planned to float 2.5 million American Depository shares at roughly $11.94 apiece. Each ADS is would represent two ordinary shares, slated […]
Helius Medical shares tank on FDA denial
Shares in Helius Medical Technologies (NSDQ:HSDT) tanked yesterday after the company said the FDA shot down its clearance bid for the portable neuromodulation device it developed. The Newtown, Pa.-based company’s PONS system is designed to treat neurological symptoms through electrical stimulation of nerves in the tongue. A trial of the PONS device in treating patients with […]
Brainsway sets terms for $30m IPO
Brainsway this week set the terms on its forthcoming initial public offering in the U.S., saying it hopes to raise nearly $30 million. The Jerusalem-based company, which developed a transcranial magnetic stimulation device to treat psychological disorders, said it plans to float 2.5 million American Depository shares at roughly $11.94 apiece. Each ADS is slated […]
FDA panel: Neuronix Alzheimer’s therapy fails to prove efficacy
An FDA advisory panel has unanimously agreed that the benefits of Neuronix’s NeuroAD system, intended to slow the progress of Alzheimer’s disease, do not outweigh the risks to patient health. Yoqneam, Israel-based Neuonix had applied for de novo clearance of the system. NeuroAD is approved for use in Europe, Australia and Israel, but the FDA panel found […]
Theranica raises $35m Series B for neuromod migraine patch
Theranica Bio-Electronics said yesterday that it raised a $35 million Series B round for the Nerivio Migra neurostim patch it’s developing to treat migraine headache. Netanya, Israel-based Theranica said VC shop aMoon led the round, joined by all of its existing backers, Lightspeed Venture Partners, LionBird, Corundum Open Innovation and Takoa. The company raised an […]
Cala Health licenses MGH-developed neuromod tech
Cala Health said this week it inked a deal to license technology from Partners Healthcare and its affiliate Massachusetts General Hospital intended to improve the company’s non-invasive neuromodulation platform for investigating and treating chronic diseases. The licensed technology was developed from research on transcutaneous vagus nerve stimulation and respiratory-gated vagal afferent nerve stimulation at a […]
FDA issues ‘leap-frog’ guidance on brain/computer interfaces
FDA has issued draft guidance for developers of devices to help amputees and people with paralysis regain mobility or their sense of touch. FDA defines brain/computer interface (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. The guidance proposes that non-clinical device testing can be used […]
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