Vara Receives World-First CE Certification for Autonomous AI in Breast Cancer Screening

Vara has received CE certification under the EU Medical Device Regulation (Class IIb) for autonomous triage in organised breast cancer screening – the first breast AI certified anywhere to report screening examinations as normal without radiologist review.

In autonomous triage, examinations the system classifies as clearly normal can be reported by AI without a radiologist reading them; every other examination continues to be read by at least one radiologist. This deployment mode is intended for organised population screening, where a shrinking radiologist workforce is straining programmes that still read every mammogram twice.

The certification has only been possible because Vara has developed a safety system that supervises the autonomous use of its AI models. "What made this possible is not the AI model alone," said Stefan Bunk, CTO and co-founder of Vara. "It is based on seven years of continuous monitoring of how our AI performs in the real world, on every single case. That experience is what allowed us to build a system that can be trusted to read without a second pair of eyes."

Vara calls it ATMON (Autonomous-Triage Monitoring): a real-time system that sets and monitors each site's operating point, tracks changes in mammography hardware, system health and daily performance signals, and reverts a site to full radiologist reading whenever those signals move outside defined limits. It provides the continuous human oversight the EU AI Act will require of high-risk AI systems.

The certification is the latest in a series of announcements underlining Vara's focus on the real-world performance of AI. In 2025, Vara published PRAIM in Nature Medicine, the largest prospective study of AI in breast screening to date, conducted nationwide without exclusion criteria across 461,818 women. Its real-world design provided an important evidence base for Vara's autonomous-triage certification.

Autonomous triage is now available to screening programmes across Europe. Any rollout follows national guidelines and each country's clinical readiness. Vara is also making ATMON, the safety system behind autonomous triage, available across its existing and new customers. The same monitoring infrastructure can now run behind every Vara deployment – from decision support to independent second reading and autonomous triage – so customers do not need to adopt autonomous triage to benefit from the safety technology built to support it.

"Studies have shown that AI can improve cancer detection. But even the best AI model's performance can shift once it operates outside the controlled conditions of a study," said Jonas Muff, CEO and co-founder of Vara. "For AI to deliver its positive impact on patient outcomes, we need to notice when this happens. We believe our ATMON system can be a template for deploying AI safely across healthcare."

About Vara – Vara (MX Healthcare GmbH) is a Berlin-based AI company for population-based early cancer detection. More than 50% of Germany's organised breast screening programme runs on Vara, with 250,000+ screenings per month. PRAIM (Nature Medicine, 2025) is the largest prospective AI screening study to date. Vara is certified for 2D mammography and 3D tomosynthesis, and analyses up to three rounds of prior exams.

For more information: www.vara.ai

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