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Vara Gains CE Certification for Autonomous Breast Cancer Screening AI

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…

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Vara Reports CE Mark Approval of its Breast Imaging AI for Independent Second Reading of Mammography

Shots: 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 &…

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