FDA clears an iCardio.ai 510(k) for its artificial intelligence software EchoMeasure for interpreting echocardiography.
FDA gives the green light to Iota Biosciences for an early feasibility study of its investigational implantable device in underactive bladder patients...
Federal Register notice: FDA makes available a final guidance entitled Endosseous Dental Implants and Endosseous Dental Implant Abutments Performance...
FDA approves a Bausch + Lomb PMA for its EnVista Envy intraocular lens for use in cataract surgery.
GSK says it will submit a BLA based on positive data from two Phase 3 trials evaluating depemokimab in chronic rhinosinusitis with nasal polyps.
FDA clears a Heidelberg Engineering 510(k) for its Spectralis Flex Module for imaging the posterior segment of pediatric and adult patients in a supin...
Federal Register notice: FDA announces that it approved on 9/17 a product application that redeemed a priority review voucher Novartis Kisqali (riboci...
FDA accepts review a PTC Therapeutics NDA for sepiapterin, indicated for treating pediatric and adult patients with phenylketonuria.
