FDA clears an In2Bones Global 510(k) for the Quantum Total Ankle.
FDA permits the de novo marketing of Caption Healths software to assist medical professionals in capturing cardiac ultrasound or echocardiography imag...
Becton Dickinson says FDA is requesting that modifications to the Alaris infusion pump will require a 510(k) filing.
Gilead Sciences works with Chinese health authorities to begin a randomized, controlled study to determine whether the companys remdesivir can safely ...
A federal grand injury indicts a former Walter Reed National Military Medical Center employee on charges involving accepting financial benefits from a...
FDA issues a draft guidance to help applicants seeking licensure for a proposed biosimilar or interchangeable biosimilar for fewer than all of the ref...
Federal Register notice: FDA seeks comments on proposed research on Health Care Providers Understanding of Opioid Analgesic Abuse Deterrent Formulatio...
Federal Register notice: FDA makes available a final guidance entitled Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-...