CapsoVision, Inc. announced on September 28, 2026, that its AI-assisted reading tool, AI Highlights, has received clearance from the U.S. Food and Drug Administration (FDA). The clearance was granted on September 25, 2026.
The AI Highlights feature is designed to support physicians in the review of small bowel capsule endoscopy studies. It is intended for use on adult and pediatric patients over the age of two who are undergoing the procedure due to suspected small bowel bleeding. The tool analyzes frames captured by the CapsoCam Plus capsule during video processing and recognizes images containing suspected abnormal lesions. These images are then highlighted and prioritized for physician review to reduce the time required to analyze the studies.
AI Highlights integrates with CapsoView, CapsoVision’s video processing and review software, and supports workflows connected to the CapsoCloud platform. The company states that the AI-processed studies can be reviewed within CapsoView or CapsoCloud workflows, depending on configuration. The tool is intended to be used by trained healthcare professionals and is not intended to replace gastroenterologists’ diagnostic interpretation or histopathological sampling.
Johnny Wang, President and Chief Executive Officer of CapsoVision, commented on the clearance, noting it represents a milestone in the evolution of the CapsoVision platform. The company stated that AI Highlights was previously launched internationally earlier in 2026, including in the European Union under the Medical Device Regulation.
