AI company scores world’s 1st approval for breast triage tool that skips radiologist review
An artificial intelligence company believes it’s the first in the world to receive regulatory approval for a breast triage tool that bypasses radiologist review for certain mammograms.
Vara announced the achievement on Wednesday, with the Berlin, Germany-based technology firm earning CE Certification under the European Union’s Medical Device Regulation. The designation applies to its autonomous triage product, which classifies mammograms as normal without a radiologist reading them.
Every other breast exam will continue to be interpreted by at least one radiologist, Vara noted. The company said this AI approach is intended for organized population screening, “where a shrinking radiologist workforce is straining programs that still read every mammogram twice” (common in Europe).
“What made this possible is not the AI model alone,” Stefan Bunk, chief technology officer and co-founder of Vara, said in a statement Sept. 2. “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.”
The product is part of Atmon, short for Autonomous-Triage Monitoring, which sets and monitors in real-time each site’s operating point while also tracking changes in mammography hardware, system health and daily performance signals. It can revert an imaging site to full radiologist reading “whenever those signals move outside defined limits.” Vara charges that Atmon can provide continuous human oversight, as will soon be required of high-risk systems under the EU AI Act.
The AI company said its certification is based on real-world performance. In one study published last year by Nature Medicine, researchers found Vara’s AI tools could increase breast cancer detection by nearly 20%. Vara said this represented the largest prospective study of AI in breast cancer screening to date, incorporating nearly 462,000 women across a dozen sites in Germany.
"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," added 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."
Vara said autonomous triage is now available to screening programs across Europe. Any rollout follows each country’s national guidelines and clinical readiness. Vara also plans to make Atmon, the safety system behind autonomous triage, available to existing customers. The same monitoring infrastructure can now run behind every Vara deployment, so customers don’t need to adopt autonomous triage to “benefit from the safety technology built to support it.”
Founded in 2018, Vara estimated that over 50% of Germany’s organized breast screening programs run on its products, processing more than 250,000 screening exams per month. Vara is certified for both 2D mammography and 3D tomosynthesis and analyzes up to three rounds of prior exams. The company’s technology is not yet available in the U.S., with Vara currently focused on the EU.
Vara also has courted investor interest, raising some $34 million in financing. This included a nearly $9 million fundraising round in 2024, which coincided with the AI firm expanded into India.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.