FDA grants Lumitron Technologies a breakthrough device designation for its HyperVIEW X-Ray system for contrast-enhanced imaging for diagnosing breast ...
HHS secretary-nominee Robert F. Kennedy Jr.s nomination moves one step closer to completion after the Senate Finance Committee voted to advance it to ...
FDA warns Indias Global Calcium about CGMP deviations in its manufacture of active pharmaceutical ingredients.
FDA approves a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic macular edema.
FDA clears a Gyder Surgical 510(k) for the Gyder Hip System and its use in positioning the acetabular cup during hip replacement surgeries.
Medtronic Neurosurgery recalls certain Becker and Exacta External Drainage and Monitoring Systems due to a risk for cracks and leaks in device stopcoc...
Federal Register notice: FDA delays by three months the effective dates of two final guidances on reducing the risk of transmission of sepsis-associat...
Olympus recalls its MAJ-891 endoscope accessory due to infection risks that may result from improper device reprocessing.
