Browsing: FDA

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Dive Brief: The Food and Drug Administration is seeking feedback on how to regulate medical devices that incorporate generative artificial…

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Dive Brief: The Food and Drug Administration has selected Cadence, a software company that makes an artificial intelligence-assisted tool for…

What You Should Know CliniComp received U.S. FDA 510(k) clearance for its PACS Viewer as a Medical Image Management and…

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Dive Brief: Caristo Diagnostics has received de novo authorization for an AI tool that quantifies coronary inflammation from routine imaging…

Dive Brief: DeepHealth last week received the Food and Drug Administration’s 510(k) clearance for an artificial intelligence tool that reads…

What You Should Know DeepHealth, Inc. (a wholly owned subsidiary of RadNet, Inc.) received FDA 510(k) clearance for DeepHealth Breast…