Vara says CE certification permits autonomous triage of normal mammograms

Vara said it received a Class IIb CE certification under the EU Medical Device Regulation for autonomous triage in organised breast-cancer screening. Under the certified mode, the system reports examinations it classifies as clearly normal without a radiologist reading them; all other examinations still go to at least one radiologist. Vara says its ATMON monitoring layer tracks site operating points, mammography hardware, system health, daily performance, cancer detection and recall rates, reverting sites to full radiologist reading when measures move outside limits. The mode does not cover symptomatic patients or diagnostic work.