Neurosigma Inc. has received FDA breakthrough device designation for its Monarch ETNS system to treat drug-resistant epilepsy (DRE). The neuromodulation therapy uses noninvasive external trigeminal nerve stimulation (ETNS) to treat neurological and neuropsychiatric indications. The technology is currently commercialized for pediatric ADHD treatment.
It’s no mystery why Scipher Medicine Corp. successfully raised $110 million in a series D financing round to further develop the company’s precision medicine platform. The company aims to address one of most modern medicine’s most challenging enigmas: how to eliminate the cost and adverse effects associated with the prescription of expensive medications that provide life-changing outcomes for some and no benefit for others. The new funds boost Scipher’s total funding to $227 million, of which $192 million has come into the Waltham, Mass.-based company’s coffers in the last 12 months.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amelia Virtual Care, Amoy Diagnostics, Benchling, Cellkey, Dovetail Genomics, Element Biosciences, GI Innovation, Lyric Health, My Telemedicine, Neurometrix, Overwatch Research, Pear Therapeutics, Precision Medicine Asia, Psious Smart Apps, Riken Genesis.
Three companies from the pharmaceutical and med-tech sectors are among this year’s most influential innovators, according to the newest edition of Clarivate plc’s Top 100 Global Innovators 2022. The pharmaceutical companies that were found to be the most innovative in the top 100 list are Johnson & Johnson, of New Brunswick, N.J., and Roche AG, of Basel, Switzerland. Royal Philips NV, of Amsterdam, was found to be the most innovative med-tech company in the top 100.
Noninvasix Inc. received a breakthrough device designation from the FDA for its noninvasive Livox central venous oxygenation monitor, which allows real-time monitoring of central venous oxygen saturation (ScvO2) in patients at risk of septic shock. The Noninvasix optoacoustic platform consists of a disposable patient interface with a reusable probe, data display and hardware.
John-Michael Havrilla, formerly the director of investor relations at Pavmed, has agreed to pay $160,000 in civil penalties over allegations he used inside knowledge of an impending earnings report to help himself to $80,000 in ill-gained profits, a sure sign the SEC is not ignoring med-tech firms in its pursuit of insider trading charges.
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