Vara has become the first company in the world to earn a CE mark for an autonomous breast cancer screening mode, clearing the way for its AI to report clearly normal mammograms with no radiologist in the loop.
The Berlin-based company said the certification covers autonomous triage for organized population screening, where a shrinking radiologist workforce is straining programs that still double-read every exam. Examinations the system flags as clearly normal are reported by AI alone; every other exam still gets at least one radiologist reading.
What made the milestone possible, said co-founder and CTO Stefan Bunk, is a safety layer the company calls ATMON, short for Autonomous-Triage Monitoring. The system continuously tracks each screening site’s performance, watches for shifts in mammography hardware and other signals, and reverts a location to full radiologist reading whenever metrics drift outside set limits. Vara argues ATMON supplies the ongoing human oversight the EU AI Act will demand of high-risk systems.
The company points to PRAIM, its 2025 Nature Medicine study across 461,818 women without exclusion criteria, as the evidence base behind the certification. Vara says more than half of Germany’s organized screening program now runs on its technology, with more than 250,000 screenings a month.
The autonomous mode is now open to screening programs across Europe, with each country’s guidelines and clinical readiness governing how quickly it is adopted. ATMON will also ship to existing Vara customers, letting the oversight layer guard decision support and independent second reads, not just fully autonomous operation.
