AnX cites FDA data on AI-assisted capsule image review times

Texas-based capsule-endoscopy company AnX Robotica highlighted clinical results in the FDA file for NaviCam ProScan on October 11. ProScan received its De Novo decision on December 12, 2023, so the announcement was not a new clearance. AnX revisited the earlier ProScan data after the FDA separately cleared CapsoVision’s CapsoView and CapsoCloud software through a 510(k) decision on September 25, 2026. The ARTIC analysis in the FDA file included 133 patients; mean small-bowel image review time was 33 minutes 42 seconds with standard physician reading and 3 minutes 50 seconds when physicians used AI assistance. The reduction calculated from those figures is 88.6%.

The FDA file reported diagnostic yields for significant lesions of 62.4% with standard reading and 73.7% with AI-assisted physician reading. AnX’s release also presented timing results from the separate FDA review of the competing software, but the studies used different systems and designs and were not head-to-head tests; they do not establish direct superiority between products. The FDA says ProScan assists physician review, is not a stand-alone diagnostic tool and does not replace clinical decision-making.