Real-time polyp detection during colonoscopy.
FDA De Novo authorization (the first and, at the time, only AI system authorized for colonoscopy, 2021); newer-generation CE marking also confirmed.
Medtronic’s own press release, which links directly to the primary FDA De Novo classification document — a primary regulatory source, not just marketing copy.
The FDA’s own De Novo classification (a primary regulatory record) was directly consulted — the strongest type of source in this batch, though it documents clearance, not independent clinical-outcomes research.
Very widely deployed; one of the most frequently cited AI tools in gastroenterology literature.
Regulatory clearance is well documented; a dedicated search for independent clinical-outcomes studies (polyp detection rate in real-world use) should still be done before publishing.
This profile is not medical advice or an endorsement. Hospitals should perform their own due diligence (regulatory compliance, GDPR, cybersecurity, integration, local clinical validation). How we evaluate
Every profile documents the precise indication, regulatory status, vendor-supported and independent evidence, real-world deployment, limits and dated sources.
A independent systematic review or prospective multicentre study · B at least one independent peer-reviewed study · C peer-reviewed, vendor-supported · D vendor claims only.
Vendors, authors and clinicians can request a correction. Corrections are dated on the profile.