FDA clears an EssilorLuxottica 510(k) for its over-the-counter Nuance Audio Glasses that provide an open-ear hearing solution integrated into a pair o...
FDA clears a Gyder Surgical 510(k) for the Gyder Hip System and its use in positioning the acetabular cup during hip replacement surgeries.
FDA approves a Vertex Pharmaceuticals NDA for Journavx (suzetrigine), a first-in-class non-opioid pain drug for treating moderate to severe acute pain...
Federal Register notice: FDA sends to OMB an information collection revision entitled Labeling Requirements for Prescription Drugs.
Federal Register notice: FDA sends to OMB an information collection revision entitled Biosimilars User Fee Program.
An FDA alert advises healthcare providers about Fresenius Kabis Ivenix large-volume pumps and their increased chance of issuing a non-recoverable pump...
Mercury Medical recalls its Neo-Tee T-Piece resuscitator due to a small spring in the controller that may prevent the device from delivering the requi...
FDA posts a final guidance entitled Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissue...