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 ...

The RNS PAS study is planned to continue to a five-year follow-up endpoint as part of the RNS System's initial FDA approval. About NeuroPace, Inc.

Akura Medical, a Shifamed portfolio company, announced today that the FDA granted its Katana system investigational device exemption (IDE).

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

Roots Community Health has sued 12 other firms, including GE Healthcare, CVS and Walgreens, and called for manufacturers and ...

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

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

Cryotherapy has long been an at-home remedy for minor injuries and conditions. In recent years, the use of whole-body ...

("NeurAxis,” or the "Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, ...

US-based Envoy Medical has received approval from the US Food and Drug Administration (FDA) for its investigational device ...

Dr. Michelle Tarver, a veteran of the Food and Drug Administration (FDA), has taken charge of the FDA’s device division at a ...

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