Intended Use

A passive notification, prioritization-only, parallel-workflow software tool used by MQSA qualified interpreting physicians to prioritize patients with suspicious findings on 2D FFDM screening mammograms.

Technology

Software as a medical device (SaMD) that uses AI algorithms to analyze 2D FFDM mammograms, providing an exam-level output flagging suspicious studies to a PACS/workstation for worklist prioritization. Operates in parallel with standard care without removing images from physician worklists. Cloud-based deployment.

Performance

Validated on 800 anonymized 2D FFDM mammograms including 399 biopsy-positive cancer cases and 401 negative cases, achieving AUROC of 0.9569, sensitivity of 87%, and specificity of 89%. Dataset included data from multiple continents and multiple mammography vendor systems.

Predicate Devices

No predicate devices specified

Ready to Sharpen Your Edge?

Subscribe to join 7,600+ peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.