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The FDA has classified three recalls as Class I because use of the devices carries the potential of serious adverse health effects and death. Read More
After an October 2022 advisory committee rejection of its initial genetic test for risk of opioid use disorder (OUD), SOLVD has won FDA approval for a revamped version of its DNA-based AvertD test. Read More
Delving into the development of AI in healthcare, Google researchers have penned an analysis of how AI has grown from a mere concept in the 1950s to be a dominant force in healthcare today, with leaders facing questions about its risks, problems and possibilities. Read More
Familiarity with FDA regulations on the agency’s processes for approving drugs and devices is lacking among doctors, but differs by specialty, according to a national survey of physicians conducted by University of California San Francisco (UCSF) researchers. Read More
This edition of Quick Notes includes coverage of a cloth vest/halter that continuously monitors blood pressure, a Mayo Clinic deal on a newly cleared breast tumor 3D modeling device, and Medtronic clearances for a deep brain stimulation system for movement disorders and an insulin delivery system. Read More
Over the past week, the FDA issued a final guidance viral safety evaluation of biotechnology product derived from human or animal cells and draft guidance on sterility information in 510(k) premarket notifications and requests for reconsideration of division level under GDUFA. Read More
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has laid out the final roadmap for 2024 to create a comprehensive set of regulations for medical devices and technology, bringing the UK one step closer to finalizing its regulatory framework after leaving the EU. Read More