Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Mainstay Medical, Spectral AI, Veritas Genetics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arrayus, Positrigo.
Researchers from Stanford University have filed for protection of their use of mechanotransduction inhibitors in coatings for surgical sutures to reduce scarring.
A collaboration led by the Flywire Consortium and comprising hundreds of scientists has completed a whole map of the adult fruit fly brain after several decades of collaborative work.
It’s well past time for the U.S. FDA to end its silence on what device patents can be listed in the Orange Book as part of a drug-device combination product, Sen. Bill Cassidy (R-La.) said in an Oct. 1 letter that took FDA Commissioner Robert Califf to task for letting the FTC do the FDA’s job.
Setpoint Medical Inc. received U.S. FDA investigational device exemption approval to initiate a study of its neuroimmune modulation platform in people living with relapsing-remitting multiple sclerosis. Setpoint plans to launch the 60-person trial in 2025 to evaluate the use of its implantable neurostimulation device to slow or reverse the nerve damage characteristic of multiple sclerosis.
Owkin Inc. partnered with Astrazeneca plc to develop an artificial intelligence (AI)-powered tool to pre-screen for germline BRCA mutations (gBRCAm) in breast cancer directly from digitized pathology slides. The companies hope that the gBRCA pre-screening solution will not only transform patients’ lives but bring value to health care systems.
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