Shots:
- Vara has secured CE certification under the EU Medical Device Regulation (Class IIb) for autonomous triage in organised breast cancer screening, enabling normal examinations to be reported without radiologist review
- ATMON (Autonomous-Triage Monitoring) is a real-time system that monitors AI performance, mammography hardware, system health, & site-level signals. If predefined limits are exceeded, the system reverts to full radiologist reading
- The triage is available across EU, with rollout subject to national guidelines & clinical readiness. Breast imaging AI was evaluated in the PRAIM study of 460,000 women, which provided evidence base of autonomous triage; data published in Nature Medicine
