Largest Real-World Study of the GI Genius(TM) Intelligent Endoscopy System Demonstrates Improved Adenoma Detection in Routine Clinical Practice
A 334,000‑procedure real‑world study links Cosmo’s GI Genius system to higher adenoma detection and broader VA adoption.
Rhea-AI Summary
Cosmo (CMOPF) reported results from the CADeNCE study, the largest real‑world evaluation of its GI Genius(TM) intelligent endoscopy system, covering more than 334,000 colonoscopies across 139 U.S. Veterans Health Administration facilities.
In this cluster‑randomised quality improvement study, 42 facilities with access to GI Genius (269 endoscopists) were compared with 97 control facilities (547 endoscopists). Availability of GI Genius was associated with 22% higher odds of adenoma detection (adjusted OR 1.22; 95% CI 1.15–1.28), with Adenoma Detection Rate increasing from 50.7% to 54.9% at CADe sites. Improvements were observed across endoscopists regardless of baseline detection rate, experience, specialty, or sex. Following study completion, the Veterans Health Administration expanded computer‑aided detection deployment to all its colonoscopy facilities.
Positive
- 22% higher odds of adenoma detection with GI Genius use (OR 1.22; 95% CI 1.15–1.28)
- Adenoma Detection Rate at CADe sites increased from 50.7% to 54.9%
- Study covered 334,000+ colonoscopies across 139 VA facilities, supporting effectiveness at scale
- Post‑study, VA expanded computer‑aided detection to all of its colonoscopy facilities
Negative
- None.
AI-generated analysis. How Rhea-AI works. Not financial advice.
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 GeniusTM system was associated with
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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FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How was the CADeNCE study of GI Genius(TM) structured in clinical practice?
The CADeNCE study was a cluster‑randomised quality improvement study under routine clinical conditions. It analysed more than 334,000 colonoscopies performed by 816 endoscopists at 139 U.S. Veterans Health Administration facilities. Among these, 42 facilities (269 endoscopists) had access to GI Genius and 97 facilities (547 endoscopists) served as controls.
Did the benefit of GI Genius(TM) depend on endoscopist experience or baseline performance?
Improvements in Adenoma Detection Rate with GI Genius were seen across endoscopists of all baseline detection rates and levels of experience, and were not moderated by specialty or sex, indicating that the benefit was not limited to lower performers.
What is the GI Genius(TM) System and how is it used in colonoscopy?
GI Genius is an artificial intelligence‑assisted endoscopy system developed by Cosmo and commercialized by Medtronic. It provides real‑time computer‑aided detection of colorectal polyps during colonoscopy to support physicians in lesion detection and quality improvement during routine practice. The device is not intended to replace clinical decision making, and detailed instructions, indications, contraindications, warnings, precautions, and potential adverse events are provided in the device manual.
What did Cosmo say about newer versions of its AI technology?
Cosmo’s MedTech AI president noted that the study used an earlier generation of the AI technology (version 2), while the newer ColonPRO(TM) system (version 4) is designed to further raise detection performance beyond what was measured in this study, supporting the company’s confidence in the continued evolution and impact of AI in endoscopy.