GI Genius

by Cosmo Artificial Intelligence - AI  · Based in Ireland → — AI-Powered Detection for Enhanced Colonoscopy Outcomes
Colorectal Surgery Gastroenterology Oncology
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Regulatory Status Disclosed

Overview

GI Genius, developed by Cosmo Artificial Intelligence – AI (a subsidiary of Cosmo Pharmaceuticals N.V.), is the first artificial intelligence (AI) assisted colonoscopy system to receive FDA marketing authorization. It functions as a computer-assisted reading tool designed to aid endoscopists in real-time detection of colonic mucosal lesions, such as polyps and adenomas, during standard white-light endoscopy examinations for colorectal cancer screening and surveillance. The system integrates with existing colonoscopy equipment, superimposing green square markers on the video feed and emitting a short, low-volume sound when a potential lesion is identified, signaling to the clinician that further assessment may be needed. This technology aims to improve the accuracy of colonoscopy by enhancing visualization and reducing the number of undetected precancerous lesions, with studies showing an increase in adenoma detection rates (ADR) and a high sensitivity rate of 99.7% with less than 1% false positives. The GI Genius platform is also designed to host multiple AI algorithms, with an AI Access™ Platform available for developers to train and validate next-generation AI models.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Use Cases

  • Colorectal cancer screening
  • Surveillance endoscopic mucosal evaluations
  • Assisting endoscopists in identifying polyps and adenomas during colonoscopy
  • Reducing miss rates of precancerous lesions
  • Enhancing visualization during colonoscopy procedures
  • Potential expansion to upper GI indications like Barrett's esophagus

Details

Category Gastroenterology AI
Pricing Contact for pricing
DeploymentIntegrates with existing colonoscopy equipment as a hardware and software module.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

The FDA authorized marketing of the GI Genius on April 12, 2021, as the first device that uses artificial intelligence to assist clinicians in detecting lesions in the colon in real time during a colonoscopy. It was reviewed through the De Novo premarket review pathway (K211951).
Integrations
EHR Not specified
Specialties Colorectal Surgery, Gastroenterology, Oncology

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Press & Coverage

Medtronic
Medtronic announces CE Mark for the next generation GI Geniusu2122 module and ColonPROu2122 software
Medtronic received CE Mark approval for ColonPROu2122, the 4th generation software for its AI-assisted colonoscopy system, GI Geniusu2122. The new software offers real-time polyp size estimation and comprehensive procedural highlights, aiming to optimize and standardize colonoscopy practice.
2026-02
Virtua Health News & Stories
GI Geniusu2122 and Colonoscopy: How AI Helps Detect Precancerous Polyps - Virtua
Virtua is utilizing GI Genius, an AI-assisted system, during colonoscopies to analyze live video feeds and highlight subtle or hard-to-see polyps, acting as a 'second set of eyes' to improve detection and strengthen colon cancer prevention.
2026-03
Penn Medicine
The next big think: Artificial intelligence arrives at Penn Gastroenterology
Penn Gastroenterology and Hepatology has introduced GI Geniusu2122, the first FDA-approved device to use AI for colon polyp detection during colonoscopy, aiming to enhance detection rates, especially in underserved communities.
2025-10
AdventHealth Blog
GI Genius: Colorectal Cancer Screening Enhanced by AI | The AdventHealth Blog
AdventHealth highlights GI Genius as an intelligent endoscopy module that enhances colorectal cancer screening by providing accurate, real-time analysis of lesions and improving viewing and diagnostic capabilities.
2025-02
Memorial Healthcare System News and Media
Memorial Healthcare System Deploys AI-Powered GI Geniusu2122 to Enhance Early Detection of Colorectal Cancer
Memorial Healthcare System has deployed GI Geniusu2122, an AI-driven technology, to enhance the detection of precancerous polyps during colonoscopies and improve patient outcomes in colorectal cancer screening.
2025-04
PubMed (The Lancet Gastroenterology & Hepatology)
Polyp detection with colonoscopy assisted by the GI Genius artificial intelligence endoscopy module compared with standard colonoscopy in routine colonoscopy practice (COLO-DETECT): a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial - PubMed
The COLO-DETECT trial, a multicenter randomized controlled trial, supports the use of GI Genius to increase the detection of premalignant colorectal polyps in routine colonoscopy practice.
2024-08
Healio Gastroenterology
AI-assisted GI Genius 'had no impact' on serrated polyp detection in positive stool tests
A study presented at the ACG Annual Scientific Meeting found that while GI Genius minorly improved adenoma detection, it had no significant impact on serrated polyp detection in patients with positive stool tests.
2024-11
OSF HealthCare Newsroom
Piloting a smarter colonoscopy - OSF Newsroom
OSF HealthCare St. Joseph Medical Center is piloting the use of GI Genius, an FDA-approved Medtronic software platform with integrated AI algorithms, which has shown an increased detection of precancerous polyps since its launch.
2024-05

Videos

Product demos, reviews, and walkthroughs for GI Genius.

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Frequently Asked Questions

The GI Genius module integrates seamlessly into the existing colonoscopy workflow by connecting between the endoscope and the display, processing video in real-time without delay. It overlays digital green boxes on suspicious areas, allowing physicians to maintain their usual view while receiving AI assistance. The system is designed for simplicity, requiring minimal learning curve for adoption as it augments, rather than alters, the physician's procedure.
GI Genius received de novo FDA clearance in April 2021, making it the first AI system approved for real-time polyp detection during colonoscopy. Regarding data privacy, the module is not connected to the facility's network, ensuring no colonoscopy video or patient healthcare information is shared with Medtronic or third parties, thereby upholding HIPAA compliance. Medtronic may collect general user experience metrics, but this is at the end-user's discretion.
While GI Genius boasts a high sensitivity rate of 99.7% and less than 1% false positives, its performance can be affected by factors like inadequate bowel preparation or rapid withdrawal speed. It is crucial to understand that GI Genius is an assistive tool and does not replace the endoscopist's clinical judgment, diagnosis, or the need for histopathological sampling. Physicians must still investigate flagged lesions and make the final clinical decisions.
Yes, other AI-powered computer-aided detection (CADe) systems are available or in development, such as CAD EYE from Fujifilm and Endo-AID. GI Genius differentiates itself by being the first AI system to receive FDA clearance for real-time polyp detection during colonoscopy. It also offers universal compatibility with major endoscope brands and Medtronic is developing an 'AI Access' program to host third-party applications.
The GI Genius module is reputed to cost approximately $100,000 per unit, with some models suggesting a monthly subscription fee. A significant challenge for widespread adoption is the current lack of a dedicated CPTu00ae code or specific reimbursement code for AI-assisted colonoscopy. Reimbursement for procedures utilizing GI Genius is currently based on the standard colonoscopy procedure codes.
GI Genius is purely an assistive technology designed to augment, not replace, the physician's thorough examination. It functions as a 'second set of eyes' to highlight potential lesions, helping to reduce the adenoma miss rate. The system explicitly states it is not intended to replace endoscopist assessment, diagnosis, or histopathological sampling, emphasizing that the clinician retains full responsibility for decision-making.
GI Genius is trained to detect colorectal polyps of various sizes, shapes, and morphologies, including small and flat lesions that might otherwise be missed. While it significantly improves the detection of adenomas and carcinomas, its performance can be influenced by factors like bowel preparation quality. The system provides real-time visual markers to alert the endoscopist, prompting closer inspection in potentially challenging anatomical areas.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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