Jason Whiting, with more than 25 years' experience in medical technology, steps in as CEO of Avation Medical Inc. He succeeds ...

Patient advocates are hoping for change under new director Michelle Tarver, while industry groups hope she will build on ...

The U.S. Food and Drug Administration announced Tuesday that it has appointed Dr. Michelle Tarver to head its divis ...

As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...

Patient advocates hope Dr. Michelle Tarver will lead the agency to focus more on safety and less on rapid approvals.

The Acclaim® Fully ImplantedCochlear Implant is differentiated from existing cochlear implants and may offer new option for hearing loss patients ...

Image Dr. Michelle Tarver, an ophthalmologist and a 15-year veteran of the F.D.A.’s medical device division.Credit...U.S.

FDA regulations categorize medical devices into three classes, with varying levels of control to manage risks and ensure the safety of medical technologies.

Regulating drug discovery and pharmaceutical manufacturing, the FDA ensures the safety and effectiveness of innovative ...

NeurAxis (NYSE:NRXS) announced today that the FDA granted an expanded 510(k) clearance for its IB-Stim non-implanted nerve ...

Michelle Tarver, MD, PhD, a 15-year veteran of the agency, is stepping into a pivotal role as the new director of the FDA's device division, taking over for Jeffrey Shuren, MD. Dr. Shuren's tenure was ...

Envoy Medical (COCH) announces that its Investigational Device Exemption, IDE, application for its pivotal study of the Acclaim Fully Implanted ...