Berlin-based Vara said Wednesday that it has won CE certification under the EU Medical Device Regulation for autonomous triage in organized breast cancer screening, a mode in which its AI reports mammograms it classifies as clearly normal without a radiologist reading them. Every other exam still goes to at least one radiologist. The company calls it a world first, and The Next Web reported that it is a Class IIb certification covering organized population screening only, not symptomatic patients or diagnostic work.
The pitch is aimed at European programs that read every mammogram twice while the radiologist workforce shrinks. Vara puts the share of screening images that turn out normal at around 97%.
A monitoring layer, not just a model
Vara credits the approval to a safety system it calls ATMON, for Autonomous-Triage Monitoring. According to Medical Product Outsourcing, it monitors each site’s operating point, mammography hardware, system health and daily performance, and automatically returns a site to full radiologist reading if predefined limits are exceeded. Vara says that provides the human oversight the EU AI Act requires for high-risk systems.
“What made this possible is not the AI model alone. It is based on seven years of continuous monitoring of how our AI performs in the real world, on every single case,” said Stefan Bunk, Vara’s CTO and co-founder. CEO and co-founder Jonas Muff said that “even the best AI model’s performance can shift once it operates outside the controlled conditions of a study,” adding, “We believe our ATMON system can be a template for deploying AI safely across healthcare.”
Autonomous triage is available to screening programs across Europe, subject to national guidelines and clinical readiness, and Vara is offering ATMON to existing and new customers in every deployment mode, including decision support and independent second reading.
What the evidence tested
Vara points to PRAIM, a study published in Nature Medicine in 2025 that covered 463,094 women at 12 German sites between July 2021 and February 2023. In it, 119 radiologists read 260,739 exams with AI support, and detection was 6.7 cancers per 1,000 in the AI group against 5.7 in the control group, a 17.6% relative increase, with recall slightly lower.
The Next Web noted that PRAIM tested AI-supported double reading, not autonomous triage, and that radiologists chose for themselves whether to use the AI, so the groups were not randomized. It also flagged that Vara’s release puts the cohort at 461,818 women, a figure the paper doesn’t carry, and that Vara hasn’t said which notified body assessed the product.
Founded in 2018, Vara estimates that more than half of Germany’s organized breast screening programs run on its products, processing over 250,000 screening exams a month, Radiology Business reported. The company analyzes up to three rounds of prior exams, is certified for 2D mammography and 3D tomosynthesis, and isn’t yet available in the U.S.
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