FDA clears a See-Mode Technologies 510(k) for its Augmented Vascular Analysis, a medical artificial intelligence software for automated analysis and r...
An anonymous source tells CNN that AstraZeneca took several weeks to deliver data to FDA on the Covid vaccine trial participant illness that led to a ...
Consumer Reports says FDA has been inappropriately redacting product names from some dietary supplement adverse event reports covering hospitalization...
The Justice Department says Merit Medical Systems will pay $18 million to resolve a whistleblower complaint that it paid advertising kickbacks to heal...
FDA clears a Livmor 510(k) for the Livmor Halo AF Detection System, a physician-prescribed wearable device that provides continuous monitoring of puls...
FDA cautions against pregnant women using prescription or OTC NSAIDs after 20 weeks because they can lead to low amniotic fluid.
FDA posts a final guidance entitled Testing for Biotin Interference in In Vitro Diagnostic Devices.
Despite being removed from her post, controversial former FDA chief spokeswoman Emily Miller remains at the agency as senior advisor to chief of staff...