FDA clears AI tool for capsule endoscopy

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CapsoVision has received FDA clearance for AI Highlights, an artificial intelligence-assisted reading tool for its CapsoCam Plus capsule endoscopy system, according to a Sept. 28 news release from the Saratoga, Calif.-based medical technology company.

The tool, cleared Sept. 25, is designed to reduce the time physicians spend reviewing small bowel capsule endoscopy studies performed for suspected small bowel bleeding in adults and pediatric patients older than 2. The AI analyzes images captured by CapsoCam Plus and flags images containing suspected abnormal lesions, prioritizing them for physician review.

AI Highlights is integrated with CapsoVision’s CapsoView video review software and supports workflows connected to its CapsoCloud platform. The company previously launched the technology internationally, including in the European Union. The tool is intended to assist trained healthcare professionals and does not replace physicians’ diagnostic interpretation.

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