Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the ...
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.
GlobalData on MSN7h
FDA issues cybersecurity risk alert over Contec patient monitorThe FDA says the cybersecurity vulnerabilities identified may put patients at risk when the device is connected to the internet.
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 ...
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