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...
Federal Register notice: FDA announces a draft guidance entitled Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions ...
Federal Register notice: FDA sends to OMB an information collection extension for Premarket Approval of Medical Devices.
GE Healthcare recalls the Carestation 600 Series Anesthesia Systems because there is a potential for a loose cable connection which could cause the de...
FDA announces a 3/23 public workshop on multi-component biomarker concepts and terminology.
FDA issues a draft guidance to help applicants seeking licensure for a proposed biosimilar or interchangeable biosimilar for fewer than all of the ref...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...