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.
Susan Krause of Rosemount alleges New Jersey-based Integra LifeSciences pressured her to lie to regulators. Integra says ...
"FDA grants 510(k) clearance to GE HealthCare’s updated ultrasound systems" was originally created and published by Medical Device Network, a GlobalData owned brand. The informa ...
Alterity plans to seek US FDA fast-track approval after posting positive phase II results for multiple system atrophy ...
In 2024, as in years past, healthcare fraud enforcement by the U.S. Department of Justice (DOJ) was substantial. Federal actions under the ...
From medical devices to OTC drugs, preemption to expert preclusion, New York state and federal courts issued decisions in ...
The FDA ban has prompted multiple claims and questions from people online. One viral social media post claims red dye No. 3 was banned from cosmetics more than 30 years ago. Other people also want ...
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