Cosmo Pharmaceuticals N.V., a global leader in AI-powered healthcare and specialty pharmaceuticals, today announced the CE certification of ColonPRO EU, its cutting-edge artificial intelligence platform for colonoscopy. This milestone, achieved on November 3, 2025 in Dublin, Ireland, marks one of the most significant advancements in the adoption of AI technologies for endoscopy in European healthcare facilities this year. ColonPRO EU, having previously obtained FDA clearance in the United States, consolidates its role as the foremost AI-assisted colonoscopy solution now available to hospitals, clinics, and health systems across Europe. The platform has already demonstrated real-world utility, supporting over four million colonoscopy procedures worldwide.

ColonPRO EU’s architecture integrates four major AI modules — Real-time Polyp Detection (CADe), Real-time Polyp Characterization (CADx), Real-time Polyp Sizing (CADs), and Procedure Highlights (CAQ) —each designed to enhance clinical workflows, diagnostic accuracy, and operational efficiency in gastrointestinal units. The CADe module, validated in international multicenter trials such as COLO-DETECT (published in The Lancet Gastroenterology & Hepatology, 2024), produces an 8.3 percentage-point improvement in adenoma detection rate compared with standard colonoscopy, directly impacting quality metrics and colorectal cancer prevention. The platform’s latest update increases specificity, reducing false positives by 9%, which is crucial for both clinical confidence and resource utilization.

The CADx characterization module allows for safe implementation of "diagnose-and-leave" strategies for diminutive polyps, a paradigm shift supported by the recent PRACTICE randomized controlled trial (The Lancet Gastroenterology & Hepatology, 2025). This approach minimizes unnecessary resections and supports cost containment without compromising patient safety—an increasingly relevant priority for European hospital managers facing budgetary pressures and a growing demand for endoscopic procedures. The newly introduced CADs polyp sizing module, validated in the multicenter METER study (Endoscopy, 2025), achieved 85.8% accuracy in size classification and 90.8% correctness in surveillance-interval assignment according to ESGE guidelines. This ensures compliance with regulatory and best-practice standards, while supporting automated, objective workflow documentation.

The CAQ procedure highlights module is engineered to capture critical performance metrics such as inspection time, bowel-preparation scores, and caecal-intubation rates in real time. This enables endoscopy department heads and hospital administrators to monitor and benchmark clinical quality, facilitate systematic process improvements, and drive value-based care initiatives. The platform’s capability to provide instant feedback and objective data aligns with the ongoing shift toward data-informed hospital accreditation, reimbursement, and population health management strategies across the European market.

Technologically, ColonPRO EU is powered by twelve concurrent neural networks on Cosmo’s proprietary NVIDIA IGX-based hardware. It operates seamlessly alongside other modules in the Cosmo Live AI ecosystem, enabling full integration into hospital IT infrastructures and digital health strategies. This positions ColonPRO EU as not just a clinical tool, but a core component in hospital digital transformation efforts, particularly in diagnostic imaging, patient monitoring, and quality assurance processes.

Cosmo’s continued investment and leadership in medtech AI are underscored by President Nhan Ngo Dinh’s statement: “With ColonPRO EU, we are setting a new benchmark for AI in endoscopy. This suite combines detection, characterization, sizing, and quality assessment in one intelligent system. It embodies our vision: an adaptive AI assistant that empowers physicians and helps hospitals continuously elevate the standard of care.” Hospital groups implementing ColonPRO EU can expect to improve clinical outcomes in colorectal cancer screening, enhance operational efficiency, lower unnecessary interventions, and advance their digitalization objectives.

Cosmo Pharmaceuticals, headquartered in Dublin and with facilities in the US and Italy, focuses on medtech AI, dermatology, gastrointestinal diseases, and contract manufacturing. Its technologies—trusted by leading pharma and hospital groups—support the transformation of healthcare delivery across Europe. ColonPRO EU’s CE mark certification is a testament to Cosmo’s commitment to innovation, evidence-based practice, and advancing population health outcomes via digital transformation in medical imaging and diagnostics.