Cosmo Pharmaceuticals Receives CE Certification for ColonPRO EU, Europe’s Most Advanced AI Colonoscopy Platform
Monday, November 03, 2025
Cosmo Pharmaceuticals N.V., a leader in AI-powered healthcare and specialty pharma, announced on November 3, 2025, that ColonPRO EU — its cutting-edge artificial intelligence software platform designed for colonoscopy — has received CE certification. This development marks an important milestone that brings the most advanced AI-assisted colonoscopy solution, previously cleared by the U.S. FDA, to healthcare providers and systems across Europe. The platform’s certification is expected to drive widespread adoption of AI-driven endoscopic technology, enhancing both clinical outcomes and operational efficiencies for European endoscopy units, hospitals, and specialty clinics.
ColonPRO EU incorporates a comprehensive suite of four real-time AI modules, representing a leap forward in the integration of artificial intelligence within routine GI endoscopy. These modules support every step of the colonoscopy procedure: detection, diagnosis, measurement, and quality assessment. The system’s Real-time Polyp Detection (CADe) component has already been validated in major international studies, including the COLO-DETECT trial published in The Lancet Gastroenterology & Hepatology (2024). The study showed an 8.3 percentage-point improvement in adenoma detection rate over standard colonoscopy — a significant advance for colorectal cancer prevention. The latest version of the software further enhances specificity, delivering a 9% reduction in false-positive findings, allowing gastroenterologists to focus on clinically relevant lesions while reducing unnecessary interventions.
The platform’s second core module, Real-time Polyp Characterization (CADx), leverages AI to support “diagnose-and-leave” strategies for diminutive polyps. This innovation, validated in the PRACTICE randomized controlled trial published in The Lancet Gastroenterology & Hepatology (2025), has demonstrated the ability to safely identify polyps that do not require resection, minimizing unnecessary procedures and streamlining workflow without compromising patient safety. This approach has wide-reaching implications for cost-saving in healthcare budgets and for improving patient experience across Europe, given the high rate of unnecessary polypectomies in historical practice.
Unique to ColonPRO EU is the Real-time Polyp Sizing (CADs) capability, newly launched in the European version after successful validation in the METER study (Endoscopy, 2025). This module delivers advanced measurement tools, achieving 85.8% accuracy in size classification and 90.8% correctness in assignment to post-polypectomy surveillance intervals, based on ESGE (European Society of Gastrointestinal Endoscopy) guidelines. With accurate polyp sizing, treatment decisions and follow-up recommendations become more precise and personalized, reducing both under- and over-surveillance burdens on already taxed European healthcare systems.
Finally, the platform’s Procedure Highlights (CAQ) module offers an automated overview of key quality indicators. This includes tracking inspection times, bowel preparation scores, and caecal intubation rates in real time. Such objective quality metrics enable institutions to continuously audit and improve endoscopic performance, contributing toward better standardized outcomes and benchmarking across Europe. Collectively, these modules harness the power of AI not just to enhance the performance of individual practitioners, but to elevate the broader standard of colorectal cancer diagnostics and prevention.
The CE certification of ColonPRO EU paves the way for deployment across European markets, marking a significant step for Cosmo Pharmaceuticals in its expansion strategy. Having already supported more than four million procedures worldwide, the system is poised to help European healthcare meet rising demand for efficient, high-quality GI diagnostics. The company emphasized the importance of this achievement, noting its commitment to driving technological innovation and supporting the transition to evidence-based, digitally enabled healthcare environments. With the regulatory green light now in hand, Cosmo will begin rolling out ColonPRO EU through its established distribution channels, with anticipated rapid uptake in centers of excellence and large academic hospitals, followed by expansion into community and smaller regional endoscopy units. The addition of ColonPRO EU to the European market is expected to set a new benchmark for quality and efficiency in colonoscopy while supporting healthcare professionals in delivering superior patient care and meeting the EU’s evolving regulatory and quality standards.
