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. Read More
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. Read More
Tokyo-based Olympus Corp. launched a new video imaging platform called Visera S (OTV-S500) in Europe and select Asian countries September 2024 while advancing more rollouts for the product worldwide. Read More
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. Read More
The U.S. Patent and Trademark Office opted to allow the 2.0 pilot version of the After Final Consideration Program to expire, bringing to an end a program that ran for longer than a decade. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abionic, Biointellisense, Elucid, Organox, SyntheticMR. Read More
