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 ...
As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...
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FDA’s new device chief faces growing pressure as AI and tech transform healthcareDr. Michelle Tarver, a veteran of the Food and Drug Administration (FDA), has taken charge of the FDA’s device division at a ...
Regulating drug discovery and pharmaceutical manufacturing, the FDA ensures the safety and effectiveness of innovative ...
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.
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 ...
FDA regulations categorize medical devices into three classes, with varying levels of control to manage risks and ensure the safety of medical technologies.
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).
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