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 & workload reduction for radiologists; data published in Nature Medicine
- The system integrates with PACS or the Vara platform, serving ~40% of Germany’s screening program, analyzing prior mammograms, with autonomous real-time monitoring to support use in both screening & diagnostic workflows
Ref: GlobeNewswire| Image: Vara | Press Release
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