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 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...
Baxter International recalls (Class 1) certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly due to report...
