AnX Robotica Cites FDA Data Showing 88.6% Cut in Capsule Review Time
AnX Robotica says FDA documents show its NaviCam ProScan AI reading technology reduced mean small-bowel capsule endoscopy review time by 88.6%, compared with 24.7% reported for a recently cleared AI-assisted platform. The company stresses that the two studies were run independently and are not a head-to-head comparison.
- AnX Robotica cites FDA documents reporting an 88.6% mean review-time reduction with NaviCam ProScan.
- A comparator cleared via 510(k) K254230 on Sept. 25, 2026 reported a 24.7% reduction.
- The FDA names ProScan (DEN230027) as the primary predicate for the newer clearance.
- The studies were independent, with different devices, patients and designs, and are not a head-to-head comparison.
- Both tools assist clinicians and do not replace their judgment.
What the FDA documents report
AnX Robotica, based in Plano, Texas, highlighted the clinical performance results of NaviCam ProScan, its AI-assisted capsule endoscopy reading technology, after the FDA cleared another AI-assisted capsule endoscopy platform. That clearance, a 510(k) decision (K254230) dated September 25, 2026, names NaviCam ProScan (DEN230027) as the primary predicate device.
For ProScan, the FDA's De Novo summary, with a decision dated Dec. 12, 2023, 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 was 62.4% with standard reading and 73.7% with AI-assisted reading.
For the comparator, the FDA's 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 mean difference of 11.3 minutes. The filing also reports AI-assisted patient-level sensitivity of 92.3% and diagnostic yield of 87.6%.
The cleared functions and the comparison caveats
According to the company, ProScan's key cleared AI functions are suspected-abnormal-image marking and digestive-tract location assistance. The comparator's functions are listed as AI Highlights, Suggested Landmarks and Green Detection.
AnX Robotica notes that the two evaluations involved different capsule systems, patient populations, study designs, readers, reference standards and validation datasets. The figures, it says, describe results reported in each product's own FDA submission and should not be read as a direct comparison.
- ProScan: De Novo pathway, 88.6% reported mean review-time reduction
- Comparator: 510(k) pathway, 24.7% reported mean review-time reduction
Assistive tools, not replacements for clinicians
Both products are intended to assist clinicians rather than replace them. The company says the 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. It adds that the comparator's clearance similarly describes its AI functions as tools to assist reviewers.
Tim Thomas, Vice President, Regulatory and Clinical Affairs at AnX Robotica, said: "The FDA documentation demonstrates that ProScan can materially reduce capsule review time while supporting a physician-led interpretation workflow." He added that "performance claims should be considered in the context of each product's cleared indication and study design."
What it means for the market
The release shows AI-assisted capsule endoscopy reading now has more than one FDA-cleared option, with the newer clearance relying on ProScan as its predicate. Because the studies differ in design and population, the published figures do not rank the products against each other. Clinicians and buyers comparing them would need to weigh each product's cleared indication and study design, as the company itself advises.
