The FDA granted a second 510(k) clearance this week to CareTaker, a Charlottesville, Virginia connected medical device company. CareTaker's device of the same name is a wearable, connected blood ...
The FDA has granted clearance for the first AI-powered handheld medical device to assist physicians in detecting all three common skin cancers: basal cell carcinoma, squamous cell carcinoma, and ...
ViTAA Medical Solutions Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510 (k) clearance for AiORTA™ Plan, the company’s fully automated, hyper-precise aortic ...
FDA classifies medical devices based on the type of device and the level of risk it poses Three main FDA clearances for medical devices are 510(k), de novo and pre-market approval Several ASX ...
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