Vara wins world’s first CE mark for AI that clears mammograms alone

Vara’s AI system earned a Class IIb CE mark, permitting autonomous triage of mammograms in organized breast-cancer screening by labeling normal exams as “clearly normal” without radiologist review; abnormal exams are still referred to radiologists. The certification depends on ATMON, a safety layer that monitors hardware, performance signals and cancer-detection metrics and reverts to full radiologist reading if thresholds are breached. Evidence derives from the PRAIM study of 463,094 women, which reported a 17.6% relative increase in cancer detection with AI-assisted double reading, though the trial did not assess autonomous triage.