Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Ele­vidys, after three patients died from ...

FDA's IDE approval for UroMems’ UroActive System follows strong feasibility clinical study results in both men and women.

The FDA has cleared the Hilo Band (G0 Blood Pressure Monitoring System) for at-home blood pressure monitoring in adults.

Generative AI chatbot for doctors called 'Prof. Valmed' earns E.U. approval. In the U.S., FDA is yet to issue guidelines on the technology's use in medicine.

The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate ...

When Medical Devices Malfunction Americans trust the FDA to make sure medical devices are safe and to act swiftly if problems arise.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled "Unique Device Identifier (UDI) Requirements for Combination ...

As devices come onto the market that have to follow the new FDA guidance of SBOMs and patching, backdoors may become easier to prevent and detect.

June 25, 2025—Embolization, Inc., a medical device company based in Boulder, Colorado, announced its nitinol-enhanced device (NED) has received FDA 510(k) clearance. The NED is a vascular embolization ...