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 ...

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

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

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 ...

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

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

Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, ...