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FDA Issues Early Alert About Risks of Peripheral Atherectomy Device
Fractures and breakages of the helix on the Rotarex system has led to 30 serious injuries, four deaths, and 115 interventions ...
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FDA Signs MOU With 8 African Countries To Strengthen Regulatory Systems
Officials of the various regulatory agencies after the signing ceremonyThe Food and Drugs Authority (FDA) has signed a Memorandum OF Understanding (MOU) with eight African National Medicine ...
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FDA notifies veterinarians of animal burn risk linked to human medical devices
Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...
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How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
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Troy Tazbaz, CDRH digital health leader, resigns
Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading key policies on artificial intelligence and software as a medical device.