FDA Clears AnX Robotica's NaviCam ProScan AI Endoscopy Device
3 reports, 1 independent
Updated Oct 11
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What happened
The U.S. Food and Drug Administration cleared NaviCam ProScan, an AI-assisted capsule endoscopy reading technology, on October 11, 2026. The FDA issued a 510(k) clearance (K254230) on September 25, 2026, identifying NaviCam ProScan as the primary predicate device.
From prnewswire.com
Why it matters
The technology is designed to assist clinicians reviewing small-bowel capsule endoscopy studies. Clinical studies showed that using ProScan decreased mean reading time from 33 minutes 42 seconds to 3 minutes 50 seconds, while also increasing diagnostic yield from 62.4% to 73.7%.
From prnewswire.com
Who's involved
- FDARegulatory agency that cleared the NaviCam ProScan device