Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amoydx, Astrazeneca, Invivo Therapeutics, Tracpatch.
The FDA’s June 2021 draft guidance for remanufacturing of medical devices wades into a highly complicated area of compliance for third-party servicing organizations that may not be familiar with FDA regulations, but the draft has sparked another set of concerns. Two trade associations said the draft would seem to suggest that original equipment manufacturers (OEMs) must disclose confidential trade secrets to give these third parties the information needed to service these devices, a suggestion that both the Medical Device Manufacturers Association (MDMA) and the Advanced Medical Technology Association (AdvaMed) said is clearly out of bounds.
The U.S. FDA’s safety and performance-based pathway (SPBP) is intended as a leaner, meaner alternative to the conventional 510(k) pathway that would sidestep some of the presumed problems with the concept of substantial equivalence. The agency recently added four device types to this program, including orthopedic fracture fixation plates.
The FDA has given thumbs up to two clinical studies for a transcatheter aortic valve replacement (TAVR) system developed by HLT Inc. to treat aortic stenosis among high-risk patients. Those studies will include aortic regurgitation which also occurs when an aortic valve doesn't open and close tightly enough but for which there are few suitable, noninvasive treatments.
Impel Neuropharma Inc. presented multiple abstracts affirming the effectiveness of Trudhesa (dihydroergotamine mesylate) nasal spray in treating migraine attacks. The data – all subsets from the phase III, open-label, pivotal STOP-301 trial – show that acute use of Trudhesa delivered via Impel’s Precision Olfactory Delivery (POD) technology may enhance patients’ quality of life by reducing migraine-associated disability, prolonging headache-free periods and limiting the number of migraine attacks over time.
Results from a new peer-reviewed study show people develop emotional bonds with artificial intelligence (AI) therapy chatbots in a similar way to in-person therapists. The study evaluated 1,205 people using a mental health app developed by Wysa Ltd. to assist symptoms of anxiety or depression. The chatbot guides users through therapy exercises including cognitive-behavioral techniques (CBT), dialectical behavior therapy, meditation, breathing and yoga to build mental resilience skills.
Lyra Therapeutics Inc.’s $100.5 million private placement has investors moving to the tune of the ear, nose and throat specialty therapeutics company. Lyra’s stock (NASDAQ:LYRA) jumped from early April trading in the $4.20 range to $6.02 with the announcement April 8 of the pending placement. The stock shot up again on April 13 when the placement finalized and surged in after-hours trading, ultimately spiking over $7 shortly after the opening bell April 14.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fosun Diagnostics.
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