FDA clears a Guard Medical 510(k) for additional large sizes of surgical incision closures (wounds up to 25cm) for treatment with its next-generation ...
FDA grants Daiichi Sankyo and AstraZeneca a breakthrough therapy designation for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating certain unrese...
FDA lifts a partial clinical hold on a MediLink Therapeutics and BioNTech Phase 1 trial evaluating BNT326/YL202 (NCT05653752), a HER3-targeted antibod...
CDRH grants a de novo marketing authorization for SoCleans 3+ Bacterial Reduction Device, an over-the-counter product intended to be used as an adjunc...
FDA grants a de novo marketing authorization to NOWDiagnostics for its at-home First To Know Syphilis Test.
Federal Register notice: FDA classifies intravenous catheter force-activated separation devices into Class 2 (special controls).
Federal Register notice: FDA classifies into Class 2 devices that are intended to detect and identify selected microbial agents that cause acute febri...
FDA issues iRhythm Technologies a Form FDA-483 after an inspection last month cited three GMP deficiencies.
