Amid recalls, Minnesota medtech exec says she was pressured to disregard safety law
Susan Krause of Rosemount alleges New Jersey-based Integra LifeSciences pressured her to lie to regulators. Integra says ...
Health Affairs59m
We Need More Robust Post-Market Surveillance For Health Care AI
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.
medtechdive2h
FDA warns about patient monitor cybersecurity vulnerabilities
Vulnerabilities in certain Contec and Epsimed patient monitors can allow people to gain access and potentially manipulate the ...
Japan Today21h
Red light therapy shows promise for pain relief, inflammation and skin conditions – but other claims might be hyped
Red light therapy is increasingly viewed as a promising treatment for wrinkles, acne, psoriasis, scars and sun-damaged skin, and as a supportive therapy for some kinds of cancer. But does red light ...
Med Device Online1h
These Were FDA's Top Citation Issues For Data Quality In 2024
Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate ...
US FDA identifies cybersecurity risks in certain patient monitors
The U.S. Food and Drug Administration (FDA) said on Thursday it had identified three cybersecurity risks associated with ...
JD Supra22h
CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional ...
STAT4h
Pharmalittle: We’re reading about FDA OK for Vertex non-opioid pain drug, vaccine advisory committee, and more
Vertex Pharmaceuticals won approval from the U.S. Food and Drug Administration for a non-opioid pain drug, clearing the way for the rollout of a product that has simultaneously sparked high hopes and ...