CapsoVision, Inc. announced it received clearance from the U.S. Food and Drug Administration (FDA) for AI Highlights™, its artificial intelligence-assisted reading feature for the CapsoCam Plus® capsule endoscopy system. The tool is designed to help physicians more efficiently review small bowel endoscopy studies by automatically identifying and prioritizing images with suspected abnormalities.

Key Details

  • FDA Clearance: Received on September 25, 2026, for the AI Highlights™ feature.
  • Product Function: The AI tool analyzes images from the CapsoCam Plus® capsule to detect and mark suspected abnormal lesions, reducing review time for physicians examining patients with potential small bowel bleeding.
  • System Integration: AI Highlights is integrated into CapsoVision’s CapsoView® software and CapsoCloud® platform, supporting existing clinical workflows without requiring a separate AI system.