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Endoscopy

GI Genius

Medtronic and Cosmo Intelligent Medical Devices

Highlights suspected colorectal polyps in real time during white-light colonoscopy.

Designed for

Endoscopist

Care setting

Endoscopy suite

Specialty

Gastroenterology

Public evidence assessedReviewed August 31, 2026

Our assessment

Bottom line

GI Genius has one of the strongest clinical evidence bases in the Atlas. Multiple prospective randomized studies support improved adenoma detection during colonoscopy. Evidence is less definitive for advanced lesions, interval cancer, mortality, over-resection, and long-term cost.

Based on public sources. RIR did not independently test this product. This is not an endorsement or recommendation.

What the evidence supports

Reviewed sources support real-time adjunctive polyp detection during defined white-light colonoscopy workflows.

What remains uncertain

Current-version performance, operator interaction, false-positive burden, and long-term patient outcomes remain outside this profile.

How it was studied

GI Genius has been tested in prospective randomized trials. COLO-DETECT randomized 2,032 participants at 12 NHS hospitals to AI-assisted or standard colonoscopy and measured mean adenomas per procedure and adenoma detection rate.

Product facts

Intended use
Assist endoscopists in detecting colonic mucosal lesions during screening and surveillance colonoscopy.
Represented version
GI Genius device family; current software and hardware configuration requires confirmation
Regulatory context
GI Genius received FDA De Novo authorization under DEN200055. Later software versions have separate regulatory records.

Sources reviewed

3 public sources represented in this evidence profile.

COLO-DETECT pragmatic randomized controlled trialPrimary evidenceFDA De Novo review for GI GeniusRegulatoryGI Genius product and indicationsOfficial product
For clinical and investment reviewEvidence context and questions for deeper review

Evidence source base

Peer-reviewed randomized evidence and FDA-reviewed pivotal evidence. Studies include manufacturer funding or supplied devices, which should remain visible.

Important limitation

Improved adenoma detection is a meaningful process outcome, but it does not by itself establish effects on advanced lesions, interval cancer, mortality, over-resection, operator behavior, or long-term cost.

Questions to ask

  1. 01Which software version is installed?
  2. 02How does performance vary by lesion morphology and bowel preparation?
  3. 03What is the effect on surveillance recommendations and outcomes?
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