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NeuroSigma

NeuroSigma wins FDA nod for ADHD device

April 22, 2019 By Brad Perriello

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Neuromodulation/Neurostimulation, Regulatory/Compliance Tagged With: NeuroSigma

NeuroSigma touts preliminary eTNS traumatic brain injury trial results

December 10, 2015 By Fink Densford

NeuroSigma Systems today released preliminary data from a trial of its Monarch trigeminal nerve stimulation system designed to treat combat veterans with traumatic brain injuries, citing improvements in memory, anxiety and brain activity. The results were presented at the North American Neuromodulation Society’s meeting in Las Vegas, the company said. The trial was performed at the Veterans […]

Filed Under: Clinical Trials, Neuromodulation/Neurostimulation Tagged With: NeuroSigma

NeuroSigma wins CE Mark for eTNS ADHD system

November 16, 2015 By Fink Densford

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 […]

Filed Under: Neurological, Regulatory/Compliance Tagged With: NeuroSigma

Epilepsy device developer NeuroSigma withdraws IPO

September 28, 2015 By Fink Densford

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 […]

Filed Under: Business/Financial News, Initial Public Offering (IPO), Neurological Tagged With: NeuroSigma

UCLA spinout NeuroSigma seeks $50m in IPO

October 1, 2014 By Alex Soule Leave a Comment

UCLA spinout NeuroSigma seeks $50m in IPO

NeuroSigma aims to reap as much as $50.2 million in its upcoming initial public offering for the UCLA spinout’s noninvasive system to treat drug-resistant epilepsy.

NeuroSigma plans to sell 3.6 million shares on the NASDAQ exchange for between $13 and $15 each, reserving the symbol NSIG, according to a regulatory filing.

Filed Under: Initial Public Offering (IPO), Neuromodulation/Neurostimulation, News Well, Wall Street Beat Tagged With: NeuroSigma

IPOs: ReWalk and NeuroSigma prepare to hit the public market

August 27, 2014 By Arezu Sarvestani Leave a Comment

IPOs: ReWalk and Neurosigma prepare to hit the public market

Two medical device makers are preparing initial public offerings for the coming weeks, breaking up a spree of biotech IPOs that have dominated the market.

Filed Under: Funding Roundup, Initial Public Offering (IPO), Neuromodulation/Neurostimulation, News Well, Robotics Tagged With: Epilepsy, NeuroSigma, ReWalk Robotics

NeuroSigma wins an FDA green light for Phase III clinical trials

July 29, 2013 By Sony Salzman

NeuroSigma

NeuroSigma is one step closer to bringing its epilepsy treatment to U.S. markets with FDA approval to begin its Phase III clinical studies.

Currently only available for investigational use in the U.S., NeuroSigma’s Monarch eTNS system is already on the shelves in Europe and Canada. Earlier studies have shown a 50% reduction in seizures for 2/5 of epilepsy patients treated, NeuroSigma said.

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Neuromodulation/Neurostimulation, News Well Tagged With: Epilepsy, Investigational Device Exemption (IDE), NeuroSigma

CircuLite, NeuroSigma land CE Marks

September 5, 2012 By MassDevice staff Leave a Comment

CE Mark

The European Union granted CE Mark approval to a pair of medical device companies, CircuLite and NeuroSigma, for their technologies designed to treat heart failure, epilepsy and depression.

Filed Under: Neuromodulation/Neurostimulation, News Well, Structural Heart Tagged With: CircuLite, NeuroSigma

Boston Scientific CFO Jeffrey Capello joins board of OvaScience | Personnel Moves

April 3, 2012 By MassDevice staff Leave a Comment

fired/hired

Boston Scientific (NYSE:BSX) executive vice president and chief financial officer Jeffrey Capello joined the board of directors at OvaScience, a Boston, Mass.-based start up developing infertility treatments.

Capello began working at Boston Scientific in 2008, landing the CFO seat in 2010. He oversees the company’s global finance, information systems, business development and corporate strategy functions.

Filed Under: News Well Tagged With: Boston Scientific, Covidien, Hansen Medical Inc., iSonea, NeuroSigma, Orgenesis, OvaScience, Personnel Moves, Response Biomedical Corp.

Cardiosolutions raises $3.3M | Funding Roundup

September 8, 2011 By MassDevice staff Leave a Comment

Cardiosolutions

Cardiosolutions Inc. landed about half of what it hopes will amount to a $6.5 million fundraising round, pulling in $3.3 million from eight un-named investors, according to a regulatory filing.

The Stoughton, Mass.-based company is a spinout from contract manufacturer STD Med, which early last year bought a new, 32,000-square-foot cleanroom to house Cardiosolutions and sister firm Spirus Medical Inc.

Filed Under: Funding Roundup, News Well, Replacement Heart Valves, Wall Street Beat Tagged With: Cardiosolutions Inc., MedShape Solutions Inc., NeuroSigma, Ohio Third Frontier, OnPoint Medical Diagnostics Inc., Philips, STD Med Inc.

NeuroSigma spinout NSVascular looks to commercialize UCLA stent technology

July 18, 2011 By MassDevice staff Leave a Comment

NeuroSigma

NeuroSigma Inc. spun out NSVascular Inc. to develop two stent lines using thin-film nitinol technology developed at the University of Calif.-Los Angeles under an exclusive licensing agreement.

Los Angeles-based NeuroSigma said its new subsidiary plans to develop one type of stent to treat brain aneurysms and another to treat peripheral artery disease.

Filed Under: News Well Tagged With: NeuroSigma, Neurovascular repair, NSVascular Inc., Peripheral

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