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Home » Medtronic wins CE mark for next-gen GI Genius module, ColonPRO software

Medtronic wins CE mark for next-gen GI Genius module, ColonPRO software

February 23, 2026 By Sean Whooley

Medtronic’s GI Genius intelligent endoscopy module
Medtronic’s GI Genius intelligent endoscopy module [Image courtesy of Medtronic]
Medtronic (NYSE: MDT) announced today that it received CE mark for its ColonPRO fourth-generation software for AI-assisted colonoscopy.

ColonPRO utilizes deep learning algorithms designed to support endoscopists in optimizing colonoscopy practice. Medtronic said its latest software marks “a significant step forward” in AI-based colonoscopy. It offers further insights with real-time polyp size estimation and comprehensive procedural highlights.

The new software bolsters the medtech giant’s GI Genius platform. Introduced in 2019, GI Genius, a computer-aided polyp detection system powered by AI, was made available in the U.S. and Europe in 2021. Medtronic designed it to redefine GI screening by assisting gastroenterologists in performing colonoscopies.

Medtronic serves as the exclusive global distributor for the GI Genius platform. GI Genius’ latest iteration, rolled out by Cosmo Pharmaceuticals in 2024, includes the FDA-cleared ColonPRO software. Medtronic and Cosmo last year announced a trial for GI Genius paired with the Apple Vision Pro system as well.

GI Genius delivers accurate polyp measurement, helping to determine appropriate surveillance intervals and improve patient outcomes. It features a real-time polyp sizing module (CADs) and a quality module (CADq) to optimize colonoscopy with automated measurements of key quality metrics. Those include inspection times, cecum detection and bowel cleanliness.

Medtronic redesigned its GI Genius module to deliver improved performance and support real-time AI applications in a single platform. Its new operating system and hardware utilize the AI Access platform and enable clinicians to run multiple applications to optimize workflows.

The company says its modules form a clinically proven and fully integrated AI suite designed to enhance every phase of colonscopy.

“Medtronic is committed to equip endoscopists with the critical insights they need to enhance outcomes and achieve greater procedural experience,” said Darin Wilson, WE-APAC business director. “The GI Genius intelligent endoscopy system has been rigorously validated across more than 30 clinical trials and 10 RCTs, demonstrating its effectiveness and reliability in real-world settings. ColonPRO brings a new level of insights to help optimise and standardise colonoscopy practice. Designed to be future-ready, it also offers the flexibility to integrate an expanding range of AI applications, ensuring endoscopists always have access to the latest innovations.”

Filed Under: Artificial Intelligence (AI), Diagnostics, Endoscopic, Featured, Health Technology, Imaging, Machine Learning (ML), Men's Health, Regulatory/Compliance, Software / IT, Urology Tagged With: CE Mark, Medtronic

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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