Vara Wins World’s First CE Mark for AI That Clears Mammograms Alone
Berlin's Vara has EU clearance for AI that reports clearly normal mammograms without the need for a radiologist.
Background
Vara, trading as MX Healthcare GmbH, announced its certification on Wednesday, according to a Business Wire statement. The mark is a Class IIb CE certification under the EU Medical Device Regulation, covering autonomous triage in organised breast cancer screening.
What the Certification Permits
The AI reports examinations classified as clearly normal without a radiologist reading them. Every other examination still receives at least one radiologist review. This mode is restricted to organised population screening, not symptomatic patients or diagnostic work.
A Different Approach
Unlike computer-aided detection tools that mark regions for a doctor to inspect, Vara’s system is designed to autonomously triage a subset of cases. The company's safety layer, called ATMON (Autonomous-Triage Monitoring), monitors the system's performance, hardware, and cancer detection rates, reverting to full radiologist reading when necessary.
The Evidence
The certification is based on PRAIM, a study published in Nature Medicine in 2025. This study involved 119 radiologists reading 260,739 cases with AI support at 12 German sites. The AI detected 17.6% more cancers than the control group.
Looking Ahead
Vara is making ATMON available to all its customers, regardless of their national guidelines or plans for autonomous triage adoption.