AnX Robotica: ProScan Cut Capsule Review Time 88.6% in FDA Filing
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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.