Plano, Texas – October 11, 2026 -- AnX Robotica said its NaviCam ProScan AI reading technology cut mean small-bowel capsule endoscopy review time by 88.6% in the study underlying its FDA De Novo clearance, against a 24.7% reduction reported for a competing AI-assisted platform cleared on September 25, 2026.
FDA names ProScan as primary predicate for the new clearance
The FDA's 510(k) clearance K254230 identifies NaviCam ProScan (DEN230027) as its primary predicate device. Both products assist clinicians reviewing small-bowel capsule endoscopy studies. ProScan received its De Novo decision on December 12, 2023.
ProScan reader study shows review time falling from 33:42 to 3:50
The FDA's De Novo summary describes the prospective multicenter ARTIC study of 133 patients. Mean small-bowel reading time fell from 33 minutes 42 seconds with standard reading to 3 minutes 50 seconds with AI-assisted reading (p<0.001). Diagnostic yield rose from 62.4% with standard reading to 73.7% with AI-assisted reading.
Comparator filing reports an 11.3-minute reduction in a 111-patient study
The K254230 summary reports a reader study of 111 patients. Mean review time dropped from 45.7 minutes to 34.4 minutes with AI assistance, a difference of 11.3 minutes. AI-assisted patient-level sensitivity was 92.3% and diagnostic yield was 87.6%.
Tim Thomas, AnX Robotica's Vice President of Regulatory and Clinical Affairs, said performance claims "should be considered in the context of each product's cleared indication and study design."
Studies differ in capsule systems, populations and reference standards
AnX Robotica stressed that the two studies are not a head-to-head comparison. They involved different capsule systems, patient populations, study designs, readers, reference standards and validation datasets.
Both products are intended to assist, not replace, clinician interpretation. The FDA's ProScan summary states that the clinician remains responsible for assessment and that ProScan is not a stand-alone diagnostic device. The comparator's clearance likewise describes its AI functions as reviewer-assist tools.