Medtronic plc’s diabetes unit posted another win with the U.S. FDA approval of the Simplera continuous glucose monitoring sensor for use with the Minimed 780G pump system, helping the company catch up with competitors Abbott Laboratories and Dexcom Inc. Medtronic plans to begin a limited launch of the Simplera Sync in the U.S. this fall. Read More
Nearly three weeks into the job, U.S. FDA Commissioner Marty Makary provided a comprehensive overview of his vision for the much-reduced agency, even as he’s taking first steps to implement his agenda. Read More
The U.S. FDA’s January 2025 draft guidance for AI-enabled device software functions has not fared well in terms of industry response. Two major trade associations argue that the draft is at least somewhat redundant with existing agency guidance. Read More
U.S. FDA warning letters typically have a noticeable effect on device manufacturing operations, but in the case of Q’Apel Medical Inc., a warning letter led to the withdrawal of a product for which the company made changes that were not cleared by the agency. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Sofwave Medical, Solo Pace. Read More
