AI is a transformational force in healthcare, but without cybersecurity as its foundation, it becomes a high-stakes gamble.

The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...

FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.

The FDA doesn’t plan to execute a reorganization of the agency but will consolidate offices that handle travel, technology, ...

The US Food and Drug Administration (FDA) has cleared OcuSciences’ retinal health assessment device, the OcuMet Beacon.

This marks the latest recall-related issue for HeartMate in recent years. Last June, the FDA deemed another recall as serious ...

The apparent reversals are the latest examples of the haphazard approach to agency cuts that have shrunk FDA’s workforce by ...

Neuralink said on social media that it received FDA breakthrough device designation for treating individuals with severe ...

Orchestra BioMed’s hypertension treatment is the latest medical device to earn the FDA’s breakthrough designation. The device is an atrio-ventricular interval modulation therapy, meaning it ...

On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug ...

DHA R&D-MRDC researchers are applying the latest regulatory guidance related to AI to better carry out their mission to ...

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a ...