Browsing: FDA

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…

What You Should Know Oxford spin-out Caristo Diagnostics has secured FDA De Novo authorization for CaRi-Heart®, making it the first…

What You Should Know Medical AI developer ThinkSono has secured FDA 510(k) clearance for ThinkSono Guidance, the first AI-powered ultrasound…

Artificial intelligence is here to stay at the FDA, but its integration and evolution may not be a straight line…

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