FDA grants Restore Medical a breakthrough device designation for its ContraBand device and its use in treating certain heart failures with reduced eje...
FDA approves a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) 10 mg tablets for relieving heartburn associated with non-erosive gastroesophagea...
FDA says two additional Warning Letters have been issued to Chinese medical device firms as part of its evaluation of defective plastic enteral syring...
FDA publishes a guidance with recommendations on clinical pharmacology considerations for conducting human radiolabeled mass balance studies of invest...
Federal Register notice: FDA makes available a final guidance entitled Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy.
FDA releases the form FDA-483 with seven observations from an inspection at the Englewood, CO-based Leiters Health outsourcing facility.
FDA says a 4/1 Philips Respironics recall revising the use instructions for its OmniLab Advanced+ ventilator is Class 1.
FDA clears a Subtle Medical 510(k) for its SubtleSYNTH, which uses deep learning to generate synthetic Short Tau Inversion Recovery images from alread...
