FDA clears an Eko 510(k) for its Eko Murmur Analysis Software for use in its smart stethoscope for detecting and characterizing murmurs.
An FDA safety communication advises that testing for monkeypox virus should use swab samples taken directly from a lesion to avoid false test results.
Federal Register notice: FDA revokes the emergency use authorization issued to ScienCell Research Laboratories for its ScienCell SARSCoV2 Coronavirus ...
Federal Register notice: FDA makes available a final guidance entitled Instructions for UsePatient Labeling for Human Prescription Drug and Biological...
FDA approves a Provepharm NDA for Bludigo (indigotindisulfonate sodium), a diagnostic dye indicated for use as a visualization aid in the cystoscopic ...
Hospira recalls one lot of propofol injectable emulsion due to the presence of a visible particulate in a single retained vial from the lot.
FDA solicits comments on software functions excluded from the medical device definition by the 21st Century Cures Act.
FDA publishes a guidance on the content and format of patient instructions for use documents for prescription drugs and biologics.