The FDA will expand generative AI tools across all centers by June 30 following a successful scientific review pilot, aiming to reduce repetitive tasks and improve operational efficiency.
The U.S. FDA is alerting healthcare providers about potential malfunctions with MitraClip Clip Delivery Systems manufactured by Abbott.
The U.S. FDA’s draft cybersecurity guidance highlights the significant impact cybersecurity incidents have had on medical networks globally.
The FDA will expand generative AI tools across all centers by June 30 following a successful scientific review pilot, aiming to reduce repetitive tasks and improve operational efficiency.
Baxter International has issued a Class I recall—the most serious type of recall—for its its Spectrum V8 and Spectrum IQ infusion pumps.
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Robert M. Callif was narrowly confirmed as the next commissioner of the FDA following divisive voting in the senate. Califf previously led the FDA in 2016.
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The FDA says the feeding set tubing can become wrapped around a child’s neck and cause strangulation or death.
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The U.S. FDA’s first medical device cyber chief Kevin Fu shares with MedTech Dive his take on medical device cybersecurity and how the agency’s regulatory policy can help improve it.
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Medtronic has received U.S. FDA approval for Vanta, a high-performance recharge-free implantable neurostimulator with a device life that can be optimized up to 11 years.
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The FDA had previously issued EUAs for decontamination systems to sterilize masks up to 10 times to combat shortages, but with its reissued EUAs the agency now says 4 times should be the max.
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The FDA added new supplies, including gloves and ventilators, to its medical device shortage list, as well as more information about the products.
