FDA clears an Odin Medical (an Olympus subsidiary) 510(k) for what it describes as the first cloud-based artificial intelligence technology to assist ...
FDA issues Regenerative Processing Plant a Warning Letter based on a 2023 inspection of the firms Palm Harbor, FL, manufacturing plant that found sign...
An April inspection of Japans Taenaka Kogyo ends in a four-observation Form FDA-483 that cites significant GMP violations.
FDA posts a Form FDA-483 issued to Biocon Biologics at the end of a July inspection at the firms Bengaluru, India manufacturing facility.
FDA publishes a draft guidance on incorporating voluntary patient preference information in medical device total life cycle regulatory decisions.
Federal Register notice: FDA sends to OMB an information collection reinstatement entitled Yale-Mayo Clinic Centers of Excellence in Regulatory Scienc...
Abbott Diabetes Care recalls (Class 1) three lots of its FreeStyle Libre 3 sensors after finding that a small number of them may provide incorrect hig...
FDA says a July Medtronic recall of some McGrath MAC Video Laryngoscopes due to potential battery problems is Class 1.
