Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allergan, Braintale, Outset Medical, Orthopediatrics, Royal Philips, Sectra, Tissium, Won Tech.
An artificial intelligence-based system can accurately detect COVID-19 using thoracic CT scans in patients with respiratory symptoms, according to a preprint study published on arXiv.org. The system can also help monitor patients with the disease. Other teams have employed AI to speed diagnosis and develop clarity on the signature appearance of the disease in the lungs of symptomatic patients.
It has been predicted that the COVID-19 pandemic would cause business disruption. Now, it has claimed a casualty with Second Sight Medical Products Inc., of Sylmar, Calif., which has been forced to wind down operations, citing the pandemic and the impact it will have on the company’s ability to secure financing. Second Sight, which makes the Argus II retinal prosthesis system, said that effective March 31, 84 of its 108 employees will be laid off.
Pear Therapeutics Inc. obtained FDA approval for Somryst, the first prescription digital therapeutic for chronic insomnia. The app provides structured cognitive behavior therapy (CBT) with clinical dashboards for physicians. While CBT is the recommended first-line therapy for insomnia, the U.S. has only 500 therapists certified to provide CBT for insomnia (CBTi) for the estimated 30 million Americans who suffer from chronic difficulty going to and staying asleep.
As the cases of COVID-19 continue to mount around the world, hospitals and other providers are looking to virtual tools, apps and other products to help people check their symptoms and get advice on whether medical intervention is needed. To that end, Dublin-based Medtronic plc has launched two new tools to help clinicians assess, monitor and triage patients with respiratory symptoms and concerns about the coronavirus.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anpac Bio, Astrotech, CDISC, Cohealo, Core Mobile, Cynergistek, Dawex, Deltatrak, Forward Science, Nanovibronix, Nexstim, Phunware, Pieces Technologies, Seek Thermal, Smiledirectclub, Well Health Technologies.
The U.S. FDA has OK’d expanded labeling for Physiq Inc.’s continuous remote monitoring system, Pinpointiq, for use during the COVID-19 pandemic. The machine learning-based platform, including Multivariate Change Index (MCI), will allow clinicians to track physiologic changes in homebound, quarantined or high-risk patients with confirmed or suspected COVID-19 – freeing up hospital beds for the most severe cases and reducing exposure of doctors and nurses to the highly contagious disease.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ads Biotec, Atum, Babcock International Group, Cerus, Diazyme Laboratories, Exthera Medical, Grifols, Henry Schein, Ifirst Medical Technologies, Integragen, Ixlayer, Kurabo Industries, Lumos Diagnostics, Microbiosensor, Orthofix, Planet Innovation, Seqster, Suse, Twist Bioscience, Tyto Care, Wittenshein.
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