ColonPRO 4.0 (CPRO40S-US)
Overview
The ColonPRO™ 4.0 (CPRO40S-US) is an artificial intelligence-based software component of the GI Genius™ intelligent endoscopy module, developed by Cosmo Artificial Intelligence – AI. It is designed to assist endoscopists in real-time detection of colonic mucosal lesions, such as polyps and adenomas, during standard white-light colonoscopy examinations for screening and surveillance. The system analyzes live video images from any compatible endoscope and provides visual markers (e.g., green boxes) on the display to highlight suspicious areas, thereby enhancing lesion detection rates and supporting clinical decision-making. It is not intended to replace the physician’s judgment.
ColonPRO™ 4.0 features improved detection performance through a retrained neural network and introduces a non-clinical “Procedure Highlights” function for data aggregation, supporting healthcare organizations in optimizing their practices.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Use Cases
- Real-time assistance during colonoscopy procedures
- Enhancing detection of colonic polyps and adenomas
- Improving adenoma detection rates (ADR)
- Supporting screening programs for colorectal cancer
- Facilitating surveillance endoscopic mucosal evaluations
- Data aggregation for practice optimization (via Procedure Highlights)
What Physicians Need to Know
Physicians should leverage ColonPROu2122 4.0 as an 'ever-vigilant second observer' to significantly enhance polyp detection, particularly for small or flat lesions that might otherwise be missed. Utilize its real-time polyp size estimation and the automated quality metrics, such as withdrawal time and cecum detection, to standardize and optimize colonoscopy practice. It's crucial to remember that while the tool greatly aids detection, it does not perform diagnoses or replace clinical decision-making and biopsy sampling. Maintain clinical judgment, especially regarding bowel preparation scoring, as the AI's accuracy in this specific area is still undergoing validation.
ColonPROu2122 4.0, as part of the GI Geniusu2122 system, is engineered for seamless integration with existing endoscopy infrastructure. It is universally compatible with current endoscopy towers, high-definition endoscopes, and leading endoscopic processor brands (e.g., Olympus, Fujifilm, Pentax), connecting directly between the video processor and the display monitor. The system's AI Accessu2122 platform is designed to support future real-time AI applications and third-party integrations. Medtronic has announced collaborations, including with Modernizing Medicineu00ae (ModMed) for its gGastrou00ae EHR software, to streamline documentation and facilitate future integration with electronic health records.
Details
| Category | Gastroenterology AI |
| Pricing | Unknown |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated ColonPRO™ 4.0 (CPRO40S-US) received FDA 510(k) clearance K241887 on January 17, 2026, as part of the GI Genius™ intelligent endoscopy module. The broader GI Genius system received its initial De Novo clearance on April 9, 2021, as the first AI-powered computer-aided detection system for colorectal polyps. |
| Integrations | |
| EHR | Not specified |
| Specialties | Colorectal Surgery, Gastroenterology |
What the Web Says
ColonPROu2122 4.0 (CPRO40S-US) is the latest software upgrade for Medtronic's GI Genius intelligent endoscopy module, an AI-assisted system designed to improve polyp detection during colonoscopies. It provides real-time visual insights, including polyp size estimation and procedural highlights, aiming to optimize and standardize colonoscopy practice. The system has received CE Mark approval and FDA clearance, with studies indicating its effectiveness in increasing adenoma detection rates and reducing missed polyps.
Overall: PositiveStrengths
- Improves AI-driven polyp detection during colonoscopy procedures, providing real-time visual insights.
- Increases adenoma detection rates (ADR) by up to 14.4% and reduces adenoma miss rates by approximately 50% compared to standard colonoscopy.
- Offers real-time polyp size estimation with 85.8% accuracy, which is significantly higher than typically reported in routine practice.
- Provides automated measurements of key quality metrics like inspection times, cecum detection, and bowel cleanliness.
- Designed to be future-ready with flexibility to integrate an expanding range of AI applications.
- Can help identify subtle lesions that physicians might otherwise miss, even for experienced endoscopists.
Limitations
- The economic value of its computer-aided quality (CAQ) program for certain metrics like total procedure time, withdrawal time, and cecal identification is questioned as these can be obtained through existing methods.
- The CAQ program's accuracy for Boston Bowel Preparation Scale (BBPS) scores is currently low, potentially altering recall recommendations.
- Its impact may be less significant among highly experienced endoscopists and in real-world clinical scenarios compared to controlled study conditions.
- Mainly enhances the detection of non-advanced, small polyps, without significantly impacting the identification of advanced and difficult-to-detect adenomas.
- Some concern exists regarding potential over-reliance on the AI system, which could lead to a drop in Adenoma Detection Rate if the system is removed.
- May lead to an increase in the removal of non-neoplastic lesions or a small increase in biopsied healthy tissue.
Based on reviews from: Medline Review, PMC, Medtronic, ASGE, G2, UCHealth, Reddit, FirstWord HealthTech, PubMed, Colon Cancer Foundation, FDA
Last updated: 2026-07-17
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