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 ...

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

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

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

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 ...

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

Element Science announced today that it received FDA pre-market approval for its Jewel patch wearable cardioverter ...

Omniasecure, which was authorized for placement in the heart’s right ventricle, is the world’s smallest defibrillation lead, ...

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 ...

drug, medical device and cosmetics companies with FDA regulatory compliance. Food Business News spoke with Lennarz about how current staff reductions at the FDA are impacting the industry now ...