Vara nets CE certification for autonomous breast screening AI triage

Vara has received CE certification under the EU Medical Device Regulation as a Class IIb device for autonomous triage in organized breast cancer screening.

Under the autonomous triage model, exams the system classifies as clearly normal can be reported by AI without a radiologist reading them, while all other exams continue to be read by at least one radiologist, according to Vara. The certification is supported by seven years of real-world performance monitoring across every case processed by the system, the firm said.

Central to the certification is Vara's Autonomous-Triage Monitoring (ATMON) system, which sets and monitors each site's operating point, tracks changes in mammography hardware and daily performance signals, and reverts a site to full radiologist reading when those signals move outside defined limits, according to the company. The certification follows the publication of the Praim study in Nature Medicine in 2025, a prospective trial of AI in breast screening conducted across 461,818 women without exclusion criteria.

Autonomous triage is now available to screening programs across Europe, subject to national guidelines and clinical readiness, according to the company. Vara said it is also making ATMON available across its existing and new customers regardless of whether they adopt autonomous triage.