Olympus Corporations’ Odin Medical receives US FDA clearance for first cloud-based AI endoscopy system for colonoscopy
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Odin Medical, an Olympus Corporation company, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the first cloud-based AI technology designed to assist gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures, the CADDIE computer-aided detection (CADe) device.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the…
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