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 ...

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 ...

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 ...

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

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

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

Successful MDSAP certification confirms compliance with Health Canada and U.S. FDA quality management system requirements, replacing FDA audit and inspection if required Health Canada and U.S. FDA ...

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

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.

Boston Scientific has agreed to buy privately held medical- technology company Cortex from medical-device investor Ajax Health in a deal that bolsters its electrophysiology portfolio.