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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…
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Vara has received CE Class IIb marking under the EU MDR for its tomosynthesis (3D mammography) AI solution, expanding its offerings for breast cancer screening programs across the EU
Vara is validated for national-scale breast cancer screening, with its scale demonstrated through PRAIM, a large prospective screening study published in Nature Medicine in 2025, supporting…
Vara Reports CE Mark Approval of its Breast Imaging AI for Independent Second Reading of Mammography
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Vara has received the European CE Mark approval for its breast imaging AI to operate as an independent second reader for both screening & diagnostic use, with EU availability starting Oct 15, 2025
Breast imaging AI was evaluated in the PRAIM study of 460,000 women across Germany, which demonstrated significant improvements in cancer detection &…

