AnX Robotica: ProScan AI Significantly Reduces Capsule Review Time

AnX Robotica has highlighted the clinical performance results of its NaviCam® ProScan™ AI-assisted capsule endoscopy reading technology. The company emphasized that the U.S. Food and Drug Administration (FDA) cleared ProScan and identified it as the primary predicate device for a recently cleared comparator AI-assisted workflow.

According to data released by the FDA, the ProScan system reduced the mean review time for small-bowel capsule endoscopy studies by 88.6%, decreasing from 33 minutes and 42 seconds to 3 minutes and 50 seconds. This is based on ProScan's De Novo submission, which included a prospective multicenter study. In comparison, a recently cleared comparator AI-assisted workflow received FDA 510(k) clearance in September 2026, reporting a 24.7% reduction in mean review time.

It is important to note that the studies for both systems were conducted independently and should not be interpreted as a head-to-head comparison. ProScan's FDA submission indicated a diagnostic yield of 73.7% with AI-assisted reading, compared to 62.4% with conventional reading. The comparator study reported an AI-assisted diagnostic yield of 87.6%.

AnX Robotica states that the FDA documentation demonstrates ProScan can materially reduce capsule review time while supporting a physician-led interpretation workflow. The company emphasizes that as AI adoption grows, performance claims should be considered in the context of each product's cleared indication and study design. Both ProScan and the comparator device are intended to assist, not replace, clinician interpretation.