HealthMammo
Zebra Medical Vision Ltd.HealthMammo is an AI-enabled software tool designed to analyze 2D full-field digital mammograms to identify and flag suspicious findings. It assists radiologists by prioritizing mammogram cases in the PACS/worklist, helping clinicians review critical cases faster and improve workflow efficiency without replacing diagnostic evaluation.
Intended Use
HealthMammo is a passive notification software tool used by MQSA-qualified interpreting physicians to prioritize patients with suspicious findings in 2D FFDM screening mammograms by analyzing and flagging suspicious exam-level findings for worklist prioritization.
Technology
HealthMammo is an AI-based software that automatically processes 2D FFDM mammography exams acquired from validated FFDM systems (specifically Hologic), analyzes mammograms for suspicious findings using a proprietary algorithm, and outputs notifications to PACS/workstation for worklist prioritization. It operates as a passive notification system working in parallel with the standard radiology workflow and includes data input validation, image analysis, integration with PACS, and error reporting features.
Performance
The performance was validated on a retrospective cohort of 835 anonymized 2D FFDM screening mammograms including biopsy-confirmed cancers and negative controls. HealthMammo demonstrated high accuracy with an AUC of 0.9661, sensitivity and specificity values at multiple operating points that met or exceeded preset performance goals. Average processing time was approximately 2.9 minutes, comparable to the predicate device. These results confirm effective triage capability and safety for clinical use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/6/2020
3 months - 2
FDA Approval
7/16/2020
Other devices from Zebra Medical Vision Ltd.
- HealthPPT2021 • 510K
- HealthCCSng2021 • 510K
- HealthJOINT2020 • 510K
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