The Cybersecurity and Infrastructure Security Agency and Food and Drug Administration Jan. 30 released notices warning of ...

The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate ...

Vulnerabilities in certain Contec and Epsimed patient monitors can allow people to gain access and potentially manipulate the ...

The approval Journey Medical received from FDA for Emrosi makes DERM an exciting stock. Click here to read more.

Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...

TAVIPILOT Soft is said to be a ‘world-first’ provision for real-time surgical guidance during TAVI and TAVR procedures.

Brenner, who worked in the FDA’s Center for Devices and Radiological Health, will take the helm of the agency until a new ...

KFDA sets global standard for generative AI medical device approval guidelines Health authority introduces pioneering ...

"Beta Bionics joins IPO uptick, aims to raise $114.4m in Nasdaq listing" was originally created and published by Medical ...

Medtech supplier Cortland Biomedical said the new designation positions it as a full-service contract manufacturer.