FDA highlights potential cybersecurity vulnerabilities in some GE Healthcare Clinical Information Central Stations and Telemetry Servers.
Federal Register notice: FDA classifies radiological computer-aided triage and notification software into Class 2 (special controls).
Federal Register notice: FDA classifies the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer into Class 2 (...
Federal Register notice: FDA issues an order to reclassify medical image analyzers, including CADe devices, for mammography breast cancer, ultrasound ...
FDA warns Gojo Industries that its Purell Advanced Hand Sanitizer products are unapproved new drugs that dont meet requirements for the tentative fina...
FDA denies a Persion petition asking that it restrict ANDA approval for generic products citing Zohydro ER as the reference-listed drug.
FDA releases a list of 15 potential drug safety signals that occurred in the fourth quarter of 2019.
Just-released approval documents shed light into how Sarepta was able to again win FDA approval for a Duchenne muscular dystrophy (DMD) drug after bei...