Czech AI Proven to Catch More Precancerous Colorectal Lesions – Now CE-Certified and Deploying Across Europe

MAIA Labs Team

MAIA Labs Team

MAIA Labs' new AI system for endoscopy is among Europe's first to achieve full MDR certification – now rolling out across European hospitals.

BRNO, CZECH REPUBLIC, June 17, 2026 /EINPresswire.com/ -- MAIA Labs, a Czech deep tech company, has received CE certification under the EU Medical Device Regulation for ColoMAIA II, its AI-powered colonoscopy assistant, clearing it for commercial sale across Europe.

The certification is supported by a prospective multicenter clinical trial involving 600 patients. The study demonstrated a 61% relative increase in adenomas – precancerous lesions detected per colonoscopy compared with standard colonoscopy.

Colorectal cancer is the second leading cause of cancer death in both the United States and Europe. It is also a highly preventable disease when precancerous lesions are detected and removed before they progress. Published studies show that a proportion of adenomas may be missed during standard colonoscopy, with reported miss rates of approximately 20–27%. This underscores the need for technologies that can support physicians in lesion detection. Every missed lesion can become a cancer three to five years later.

ColoMAIA II acts as a second pair of eyes during the procedure, detecting adenomas and assessing dozens of additional metrics in real time, while requiring no changes to established clinical workflows for physicians or patients.

“The data confirms we’ve built the most clinically advanced system of its kind. Now we’re focused on what matters most – getting this technology to physicians and patients around the world,” says Lukas Loun, Founder and CEO of MAIA Labs.

The system is currently deployed in more than twenty European hospitals. Brno-based MAIA Labs is accelerating commercial expansion and seeking distribution partners in new markets, supported by the Czech innovation agency JIC. MAIA Labs continues to advance its technology by pursuing FDA certification and conducting ongoing research, including collaborations with leading institutions such as Mayo Clinic and Cleveland Clinic.

“Healthcare is one of the few AI markets where leadership cannot be built overnight. Access to clinical data, physician trust, and regulatory certification creates barriers that take years to overcome. We are proud to have built this foundation and want to use the momentum,” adds Loun.

ColoMAIA II connects to any standard endoscopy tower with no hardware replacement, runs detection automatically during the procedure, and generates a structured quality report before the physician leaves the room. This eliminates more than one hour of manual documentation per day and exports findings directly to hospital EMR and PACS systems.

About MAIA Labs

MAIA Labs is a Czech deep tech startup developing AI systems for endoscopy that help physicians improve procedure quality and automate documentation. It has been recognised as one of Europe’s most promising health technology startups at the Global Startup Awards and works with leading hospitals in Europe and the United States.

www.maia-labs.com

Jana Pokorná
JIC
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