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Largest Real-World Study of the GI Genius(TM) Intelligent Endoscopy System Demonstrates Improved Adenoma Detection in Routine Clinical Practice

Key Takeaway: Cosmo Pharmaceuticals announced the results of its CADeNCE study, the largest real-world study of the GI Genius™ Intelligent Endoscopy System. The study demonstrated a 22% increase in adenoma detection rates among endoscopists using the system, validating previous randomized studies. Following the study, the Veterans Health Administration expanded the deployment of this technology across its facilities.

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POSITIVE FACTORS

  • The GI Genius system significantly improved adenoma detection rates.
  • The study validates previous findings in a real-world setting.
  • Deployment of CADe technology expanded across Veterans Health Administration facilities.
  • Improvements were consistent across various endoscopist experience levels.

Full Press Release Details

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September 21, 2026 1:07 AM EDT | Source: Cosmo Pharmaceuticals N.V.
Dublin, Ireland--(Newsfile Corp. - September 21, 2026) - Cosmo N.V. (SIX: CMHC) (FSE: C43) ("Cosmo") today announced the results from its CADeNCE study. The study, led by Dominitz et al. and published in Gastroenterology , is the largest cluster-randomised quality improvement study of computer-aided detection (CADe) in colonoscopy. It analysed more than 334,000 procedures performed under routine clinical conditions by 816 endoscopists across 139 U.S. Veterans Health Administration facilities.
Among participating sites, 42 facilities (269 endoscopists) had access to CADe and 97 facilities (547 endoscopists) served as controls.
The study evaluated the impact of the GI Genius™ system on the Adenoma Detection Rate and showed that the availability of the GI Genius TM system was associated with 22% higher odds of detecting an adenoma (adjusted OR 1.22; 95% CI 1.15 to 1.28), with Adenoma Detection Rate rising from 50.7% to 54.9% at CADe sites.
Improvements were seen across endoscopists of all baseline detection rates and levels of experience, and were not moderated by specialty or sex, indicating the benefit was not limited to lower performers.
The findings support that improvements in adenoma detection observed in previous randomized studies can also be achieved under routine clinical practice conditions. Following completion of the study, the Veterans Health Administration expanded deployment of computer-aided detection across all of its colonoscopy facilities.
Nhan Ngo Dinh, President, MedTech AI at Cosmo, said: "This a great example of a real-world validation of the technology that Medtronic and Cosmo brought to Gastroenterology, and it shows that the benefit holds at national scale and across the full range of endoscopist experience. What it excites me the most is that this study was conducted using an earlier generation of our AI technology (version 2), while ColonPRO™ (version 4) takes this even further, with technologies designed to raise detection performance beyond what this study measured — underscoring our confidence in the continued evolution and impact of AI in endoscopy."
Please Note: The U.S. Department of Veterans Affairs does not support nor endorse one vendor over another.
About GI Genius™ System GI Genius™ System is an artificial intelligence-assisted endoscopy system developed by Cosmo and commercialized by Medtronic. The system provides real-time computer-aided detection of colorectal polyps during colonoscopy to support physicians in lesion detection and quality improvement during routine clinical practice. This device is not intended to replace clinical decision making. For detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events, please consult the device manual. For further information, contact your local Medtronic representative. GI Genius is a registered trademark of Medtronic.
About Cosmo Cosmo is a life sciences company focused on MedTech AI, dermatology, gastrointestinal diseases, and contract development and manufacturing (CDMO). We design, develop, and manufacture advanced solutions that address critical medical needs and raise the standard of care. Our technologies are trusted by leading global pharmaceutical and MedTech companies and reach patients and healthcare providers around the world. Guided by our purpose - Building Health Confidence - our mission is to empower patients, healthcare professionals, and partners by innovating at the intersection of science and technology. Founded in 1997, Cosmo is headquartered in Dublin, Ireland, with offices in San Diego (USA), and in Lainate, Rome, and Catania (Italy). For more information, visit www.cosmohealthconfidence.com .
For further information, please contact: investor.relations@cosmohc.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/315150
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Frequently Asked Questions

What is the GI Genius system?

The GI Genius system is an AI-assisted endoscopy technology that aids in detecting colorectal polyps during colonoscopy.

What were the results of the CADeNCE study?

The study found a 22% increase in adenoma detection rates among endoscopists using the GI Genius system.

How many procedures were analyzed in the study?

The CADeNCE study analyzed over 334,000 colonoscopy procedures across 139 facilities.

Who conducted the CADeNCE study?

The study was led by Dominitz et al. and published in the journal Gastroenterology.

Last updated: Sep 21, 2026