CapsoVision Announces FDA Clearance of AI Highlights for CapsoCam Plus®

SARATOGA, Calif., Sept. 28, 2026 (GLOBE NEWSWIRE) -- CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today announced that AI Highlights™, its AI-assisted reading tool for the CapsoCam Plus system, received clearance from the U.S. Food and Drug Administration (FDA) on September 25, 2026.

AI Highlights is designed to support physicians in the review of small bowel capsule endoscopy studies collected from adult and pediatric patients (over two years of age) in whom the study was performed due to suspected small bowel bleeding, specifically to reduce the time taken to review capsule endoscopy images. It does so through recognizing and marking images containing suspected abnormal lesions, which are highlighted and prioritized for physician review. The feature integrates with CapsoView®, CapsoVision’s video processing and review software, and supports workflows connected to the Company’s CapsoCloud® platform. During video processing, the AI algorithm analyzes frames captured by the CapsoCam Plus capsule. AI-processed studies can then support physician review within connected CapsoView or CapsoCloud workflows, depending on workflow configuration.