AnX Robotica today highlighted the documented results of the clinical performance of NaviCam® ProScan™, its AI-assisted capsule endoscopy reading technology, following a recent U.S. Food and Drug Administration clearance of another AI-assisted capsule endoscopy platform.
In its September 25, 2026, 510(k) clearance (K254230), the FDA identifies NaviCam ProScan (DEN230027) as the primary predicate device.1
Both technologies are designed to assist clinicians reviewing small-bowel capsule endoscopy studies. In their respective FDA submissions, both products demonstrated reductions in mean review time, although the studies were conducted independently and should not be interpreted as a head-to-head comparison.
For ProScan, FDA’s De Novo summary reports that the prospective multicenter ARTIC study included 133 patients and found mean small-bowel reading time decreased from 33 minutes 42 seconds with standard reading to 3 minutes 50 seconds with AI-assisted reading (p<0.001). Diagnostic yield was 62.4% with standard reading and 73.7% with AI-assisted reading.2
For the recently cleared comparator, FDA’s K254230 summary reports that its reader study used 111 patients and found mean review time decreased from 45.7 minutes to 34.4 minutes with AI assistance, a mean difference of 11.3 minutes. The filing also reports AI-assisted patient-level sensitivity of 92.3% and diagnostic yield of 87.6% in that study.3
“The FDA documentation demonstrates that ProScan can materially reduce capsule review time while supporting a physician-led interpretation workflow. As AI adoption grows, performance claims should be considered in the context of each product’s cleared indication and study design. We believe the clinical evidence supporting ProScan provides a strong foundation for efficient, AI-assisted capsule endoscopy review.”
-Tim Thomas, Vice President, Regulatory and Clinical Affairs, AnX Robotica
The ProScan and comparator studies were separate clinical evaluations involving different capsule systems, patient populations, study designs, readers, reference standards, and validation datasets. The figures above therefore describe results reported in each product’s FDA submission. Both products are intended to assist, not replace, clinician interpretation. FDA’s ProScan De Novo summary states that the clinician remains responsible for assessment and that ProScan is not intended as a stand-alone diagnostic device. The comparator’s clearance similarly describes its AI functions as tools to assist reviewers.
