CapsoVision has received FDA clearance for AI Highlights, an AI-assisted reading tool for its CapsoCam Plus wireless capsule endoscopy system. The tool is designed for adult and pediatric patients over age 2 undergoing small-bowel capsule endoscopy for suspected bleeding.
AI Highlights analyzes capsule video frames and identifies and highlights images containing suspected abnormal lesions, allowing physicians to prioritize those images during review. The technology is integrated into CapsoVision’s CapsoView image-review software and CapsoCloud workflow, which can support remote physician review and case management.
The company says the tool is intended to help reduce the time required to review capsule endoscopy studies. It is designed to support—not replace—gastroenterologists’ diagnostic interpretation and, where applicable, histopathological sampling.
The FDA clearance follows the tool’s earlier international launch, including in the European Union.