GI Genius System 100 and GI Genius System 200

by Cosmo Artificial Intelligence - AI Ltd. (a subsidiary of Cosmo Pharmaceuticals N.V.)  · Based in Ireland → — Powered by artificial intelligence to help you detect early, treat early.
Colorectal Surgery Gastroenterology
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Regulatory Status Disclosed

Overview

The GI Genius System 100 and GI Genius System 200 are advanced artificial intelligence (AI)-powered computer-assisted detection (CADe) systems designed to enhance endoscopic examinations. This medical device aids endoscopists in the real-time detection of colonic mucosal lesions, such as polyps and adenomas, during standard white-light endoscopy procedures for both screening and surveillance.

The system functions by analyzing the live video feed from an endoscope and superimposing visual markers, typically green squares, along with a low-volume audible signal, when it identifies a potential lesion. This technology is intended to serve as an adjunct to the gastroenterologist, providing an ‘ever-vigilant second observer’ to improve the accuracy of lesion identification and increase the adenoma detection rate (ADR).

The GI Genius is compatible with various FDA-cleared standard video endoscopy systems and integrates seamlessly into existing endoscopy setups. It is crucial to note that the device is not intended to replace clinical decision-making but rather to support physicians in their diagnostic efforts.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Real-time AI-assisted polyp and lesion detection during colonoscopy
  • Visual markers (green squares) and audible alerts for suspicious regions
  • Compatibility with existing standard white-light endoscopy systems
  • Demonstrated increase in adenoma detection rate (ADR)
  • High sensitivity rate of 99.7% for lesion detection
  • Low false positive rate (less than 1%)
  • Aids in detecting polyps of various sizes, shapes, and morphologies
  • GI Genius System 200 offers 4K UHD capability
  • Leverages deep learning algorithms and computer vision techniques
  • Designed as an adjunct tool, not to replace clinical decision-making

Use Cases

  • Colorectal cancer screening and surveillance
  • Real-time detection of colonic mucosal lesions (polyps, adenomas)
  • Enhancing endoscopist performance in polyp detection
  • Integration with existing endoscopy equipment for improved workflow
  • Potential for expansion into upper gastrointestinal (GI) indications

What Physicians Need to Know

Polyp Detection During Colonoscopy
The GI Genius System is a computer-aided polyp detection (CADe) system powered by AI, designed to assist endoscopists in real-time detection of colonic mucosal lesions, including polyps and adenomas, during standard white-light colonoscopy. It highlights suspicious areas with visual markers (green boxes) on the screen. The system boasts a 99.7% sensitivity rate and less than 1% false positives. It effectively aids in detecting polyps of various sizes, shapes, and morphologies, including small and flat polyps that might otherwise be missed.
Real-Time Endoscopy AI
The GI Genius operates in real-time, continuously scanning every visual frame from the colonoscope in milliseconds and alerting physicians to the presence of potential lesions. It superimposes graphical overlay markers directly onto the live endoscopic video feed without introducing a perceivable delay.
Adenoma Detection Rate Improvement
The system has been shown to significantly increase the Adenoma Detection Rate (ADR) by up to 14.4% and a 12% relative increase in the likelihood of detecting at least one adenoma. A 1% increase in ADR is associated with a 3% decrease in the risk of interval colorectal cancer. It particularly enhances the detection of small (<10 mm) polyps and sessile serrated lesions (SSLDR).
GI Pathology Analysis
While primarily a detection (CADe) system, GI Genius version 3 includes a computer-aided diagnosis (CADx) module for polyp characterization, which has received CE clearance. This feature provides information about the nature of abnormalities, though the main focus remains on real-time detection.
Quality Metrics Tracking
The GI Genius system directly impacts and improves a key quality measure in colonoscopy: the Adenoma Detection Rate (ADR). Its consistent performance helps ensure a standardized level of detection, contributing to overall quality improvement in endoscopic procedures.
Endoscopy System Compatibility
The GI Genius System is designed for seamless integration and universal compatibility with existing endoscopy towers and high-definition endoscopes. It is compatible with major brands of endoscopic processors, including Olympus (CV-180 EXERA II, CV-190 EXERA III), Fujifilm (VP-7000, VP-4450HD), and Pentax (EPK-i7000). The system connects between the video processor and the endoscopic display monitor. The GI Genius Module 200 also supports 4K UHD standard video processors.
Physician Tip

Utilize the GI Genius as an 'ever-vigilant second observer' to augment your visual inspection during colonoscopy, especially for subtle, small, or flat lesions that are easily missed. Remember that the system is a computer-assisted tool and not a replacement for clinical decision-making; further assessment and intervention remain at the clinician's discretion. Leverage its real-time alerts to enhance detection rates and improve patient outcomes in colorectal cancer screening and surveillance. Consider its use for all eligible colonoscopies, ensuring appropriate team training for optimal response to system prompts.

The GI Genius system is engineered for straightforward integration into existing endoscopy suites. It requires only your current endoscopy tower and high-definition endoscope. The module connects directly between your video processor and display monitor, making it a plug-and-play solution compatible with leading endoscope brands (Olympus, Fujifilm, Pentax) without altering your established procedural workflow.

Details

Category Gastroenterology AI
Pricing Contact for pricing — Not disclosed
DeploymentHardware and software system connected between the video processor and the endoscopic display monitor.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The GI Genius System 100 and GI Genius System 200 received FDA 510(k) clearance (K231143) on May 19, 2023, as a Class II device for gastrointestinal lesion software detection. The broader GI Genius intelligent endoscopy system was initially authorized for marketing by the FDA in April 2021, marking it as the first device to use AI to help detect potential signs of colon cancer.
Integrations
EHR Not specified
Specialties Colorectal Surgery, Gastroenterology

What the Web Says

The GI Genius System 100 and GI Genius System 200 are AI-powered computer-assisted detection devices designed to help endoscopists identify colonic mucosal lesions, such as polyps and adenomas, in real-time during colonoscopy screenings. The System 200 offers 4K UHD capability and is compatible with the Olympus CV-1500 EVIS X1 video processor. Both systems have received FDA clearance as Class II medical devices.

Overall: Positive

Strengths

  • Aids endoscopists in detecting colonic mucosal lesions in real-time.
  • Utilizes artificial intelligence to process colonoscopy images.
  • GI Genius System 200 offers 4K UHD capability.
  • Compatible with various video processors and endoscopic display monitors.
  • FDA-cleared as Class II medical devices.

Limitations

  • Not intended to replace clinical decision-making.
  • Limited for use with standard white-light endoscopy imaging only.
  • No specific physician, healthcare IT, tech reviewer, Reddit, G2, or Capterra reviews were found in the search results to detail cons.

Based on reviews from: FDA, Becker's ASC, Innolitics

Last updated: 2026-07-20

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Press & Coverage

RadAI Slice
GI Genius System 100 and GI Genius System 200 | FDA Radiology AI Device
The GI Genius System 100 and 200 are AI-powered computer-assisted detection tools cleared by the FDA in May 2023, designed to help doctors identify colonic lesions during colonoscopy in real time. The System 200 supports 4K UHD video processing, while the System 100 uses standard HD input.
2023-05
FDA
K231143 - 510(k) Premarket Notification - FDA
This FDA 510(k) premarket notification details the clearance of the GI Genius System 100 and GI Genius System 200, submitted by Cosmo Artificial Intelligence - AI, Ltd. The document outlines the regulatory information and classification for these gastrointestinal lesion software detection systems.
2025-12
PR Newswire
Medtronic and Cosmo Pharmaceuticals forge ahead in AI-driven care - PR Newswire
Medtronic and Cosmo Pharmaceuticals expanded their partnership in December 2023, with Medtronic paying Cosmo $100 million upfront and potential milestone payments for the AI-powered GI Genius module. This collaboration aims to further integrate AI into endoscopic procedures to improve patient care.
2023-12
Medtronic
Medtronic Expands Partnership with Cosmo Pharmaceuticals
Medtronic announced an expanded partnership with Cosmo Intelligent Medical Devices in December 2023, focusing on the GI Genius intelligent endoscopy module. The agreement grants Medtronic exclusive global commercial rights and involves significant upfront and milestone payments to Cosmo.
2023-12
Medical Device Network
Medtronic partners with Cosmo to use AI to improve endoscopic software
This article details the expanded partnership between Medtronic and Cosmo Pharmaceuticals, highlighting the $200 million deal to further integrate AI into endoscopic modules like the GI Genius. The collaboration also includes developing scalable AI platforms such as AI Access.
2023-12
Fierce Biotech
Medtronic doubles down on endoscopy AI partnership, inking $200M deal with Cosmo Pharmaceuticals - Fierce Biotech
Medtronic's expanded partnership with Cosmo Pharmaceuticals, valued at up to $200 million, aims to build a platform for multiple AI-powered diagnostics. The GI Genius system, which detects polyps during colonoscopies, has been exclusively distributed by Medtronic since 2021.
2023-12
Newsfile Corp.
Cosmo Intelligent Medical Devices Unveils Next Generation GI Genius(TM) Hardware with New FDA Clearance - Newsfile Corp.
Cosmo Intelligent Medical Devices announced FDA 510(k) clearance for its next-generation GI Geniusu2122 hardware in July 2024, which includes the FDA-cleared ColonPROu2122 software. This advancement aims to enhance physician performance with sophisticated AI-driven insights during endoscopic procedures.
2024-07
Becker's ASC Review
The 10 AI algorithms FDA-cleared for gastroenterology - Becker's ASC
As of May 2024, the FDA has cleared 882 AI/ML-enabled medical devices, including 10 gastroenterology products, among which are Cosmo Artificial Intelligence's GI Genius System 100 and GI Genius System 200.
2024-05

Videos

Product demos, reviews, and walkthroughs for GI Genius System 100 and GI Genius System 200.

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Frequently Asked Questions

Both GI Genius System 100 and 200 are AI-powered computer-assisted detection (CADe) tools designed to identify colonic lesions in real time during white-light endoscopy. The primary distinction is that System 200 supports 4K UHD video processing, converting it for AI analysis and then back to UHD output, while System 100 uses standard HD input. Both systems integrate seamlessly with existing endoscopy towers and display monitors, overlaying green markers and providing sound alerts for suspicious areas without altering the video stream or replacing clinical judgment.
The GI Genius System 100 and 200 have received FDA clearance (initially in 2021 for GI Genius, and then for 100/200 in 2023) and CE Mark approval (for earlier versions in 2019). Regarding data privacy, the GI Genius module is designed not to connect to the account network, meaning no colonoscopy video or patient healthcare information is shared with Medtronic or other third parties under certain agreements. It is intended for prescription use and not as a standalone diagnostic device, adhering to regulatory guidelines.
Clinical studies indicate that the GI Genius System can increase the adenoma detection rate (ADR) by up to 14.4% and reduce adenoma miss rates by approximately 50%, particularly for non-advanced adenomas. However, it is not intended to replace clinical decision-making or lesion characterization for biopsy, and its performance may be negatively affected by mucosal irregularities or in patients with inflammatory bowel disease, a history of colorectal cancer, or previous colonic resection. There is also a caution against potential user complacency due to over-reliance on the system.
Several other AI-powered computer-aided detection (CADe) systems are available or in development for colonoscopy, such as Endo-AID and EndoMind. These alternatives also aim to enhance polyp detection rates by analyzing real-time endoscopic images. Comparative studies evaluate their performance based on metrics like sensitivity, specificity, and false-positive rates, which can vary across different systems and their software versions.
Specific pricing for the GI Genius System 100 or 200 is not publicly detailed, but it generally involves a capital acquisition and a service plan for ongoing support and software upgrades. For eligible patients, procedures utilizing GI Genius may be covered by insurance at no additional cost, especially through programs like the Medtronic and AWS Health Equity Assistance Program for underserved communities. Reimbursement pathways for AI-assisted colonoscopy are evolving, with ongoing discussions to establish specific codes and ensure appropriate payment for the added value and costs associated with these advanced technologies.
Minimal training is required for endoscopists and staff, as the GI Genius System does not alter the colonoscopy technique; Medtronic representatives typically provide installation and in-service training with live support during initial procedures. The system is designed for seamless integration with existing endoscopy towers and high-definition endoscopes from various manufacturers. Best practices include coordinating training with the local Medtronic representative and ensuring compatibility with current video processors to facilitate smooth adoption into a busy endoscopy unit.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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