Capsule endoscopy produces hours of images that a physician scrolls through by hand. CapsoVision now has FDA clearance for software that handles the first pass.
The agency cleared AI Highlights on September 25, and the Saratoga, California company announced the decision on September 28. The tool works with CapsoCam Plus, the company’s pill-sized camera, in adults and children older than two whose study was ordered for suspected small-bowel bleeding. The algorithm scans frames during video processing, marks the ones that look like lesions, and pushes those to the front of the review queue.
It runs inside CapsoView, CapsoVision’s review software, and fits studies handled through CapsoCloud. Chief executive Johnny Wang framed the clearance as the US counterpart to an international launch earlier this year, which included the European Union under the Medical Device Regulation.
The clinical pitch is throughput. Capsule studies are bounded by how long a reader can stay attentive, so filtering frames could widen access to a test that often stands in for deeper procedures. Accuracy is a separate matter: the agency cleared the tool to prioritize images for a physician, not to diagnose on its own.
