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

Randomized empirical evaluation of computer-aided detection, with more than 334,000 colonoscopies performed across U.S. Veterans Health Administration facilities, showed improved adenoma detection

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.

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