CapsoVision Wins FDA Clearance for AI Highlights Reading Tool on CapsoCam Plus

CapsoVision, Inc. (CV) said the U.S. Food and Drug Administration cleared its AI Highlights assisted reading tool for the CapsoCam Plus capsule endoscopy system on September 25, 2026. The stock trades at $6.63, down 0.38%, within a 52-week range of $4.38 to $15.37. The tool flags frames containing suspected lesions in small bowel studies of adults and children over age two with suspected small bowel bleeding, prioritizing them for physician review to cut reading time. It integrates with CapsoView software and CapsoCloud workflows, supporting remote review and case management. The clearance is part of broader CapsoView and CapsoCloud software updates. AI Highlights, previously launched in the European Union under Medical Device Regulation, is not intended to replace gastroenterologist interpretation. CapsoVision is also developing CapsoCam Colon with AI for polyp detection.