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Intended Use

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) pathologies. The results are to be used alongside other patient information and professional judgment to assist triage/prioritization.

Technology

The device uses an AI algorithm incorporated in software that operates via modules for image acquisition, processing, and workflow integration. It receives DICOM images, processes them to detect suspected findings, and sends notifications with compressed preview images to radiologists. It runs in parallel with standard image interpretation without altering original images or removing cases from reading queues.

Performance

A blinded, retrospective multicenter study of 383 head CTA images showed a sensitivity of 88.8% and specificity of 87.2% for LVO detection, exceeding performance goals. Mean time-to-notification was 3.8 minutes, comparable to predicate devices, facilitating faster triage.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    8/30/2019

    3 months
  • 2

    FDA Approval

    12/20/2019

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