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).
NeurAxis (NYSE:NRXS) announced today that the FDA granted an expanded 510(k) clearance for its IB-Stim non-implanted nerve ...
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 ...
GlobalData on MSN1d
FDA grants clearance for study of Envoy Medical’s cochlear implantUS-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 ...
GlobalData on MSN3d
FDA’s final rule on LDTs causes concern, but timeline looks unsteadyThe FDA's final rule of LDTs includes a four-year phaseout to bring IVDs under its regulation, but there are obstacles.
Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a ...
The Acclaim® Fully ImplantedCochlear Implant is differentiated from existing cochlear implants and may offer new option for hearing loss patients ...
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