Former FDA officials at a NAMSA-hosted panel urged medical device manufacturers to maintain inspection readiness under the ...

Attorney Tina Hu-Rodgers explains why FDA's risk-based framework needs rethinking for agentic AI, and what medtech companies ...

Teleflex is currently evaluating Freesolve in the BIOMAG-III Pivotal Trial to support a future premarket approval application.

Provider groups are lobbying the Food and Drug Administration to make tech companies responsible for the safety and performance of generative AI-backed medical devices, arguing the tools’ makers are ...

Edwards’ approval should “strengthen the company’s position in the large and underpenetrated transcatheter tricuspid market,” ...

The Centre has directed states to enforce a ban on reusing single-use medical devices, citing infection risks, patient safety concerns and allegations that patients were charged full prices for reused ...

Rafferty Domnick Cunningham & Yaffa is a leading Florida law firm dedicated to advocating for victims of mass torts, medical malpractice and corporate negligence. With a track record of holding ...

ATA Action submits comments on the FDA's generative AI discussion paper, calling for manufacturer accountability, federal-state sandboxes, and PCCPs.

Potentially accelerates development, assessment, and review for approval by FDA Sepsis impacts about 1.7 million U.S. adults annually and contributes to nearly one in three in-hospital deaths DENVER, ...

A two-day public workshop on evaluating robotic surgery systems with autonomous or remote capabilities is also on the agency’s agenda, as telesurgery advances globally.

Permitting medical device manufacturers to submit bulk summary reports of adverse events to the U.S. Food and Drug ...

More consumer wellness companies are pursuing FDA clearance, and the timing of that decision reveals their strategy.