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Intended Use

Notification-only, parallel workflow tool for hospital networks and trained clinicians to identify and communicate images suggestive of intracranial hemorrhage on non-contrast CT brain images within 24 hours of symptom onset or last known well time, to notify specialists parallel to standard care interpretation.

Technology

Standalone software using machine learning algorithms with advanced non-adaptive imaging algorithms and artificial intelligence to analyze non-contrast CT brain images for hyperdense volumes indicative of intracranial hemorrhage. Runs on standard physical or virtual servers, compliant with DICOM standard, provides priority notifications and image previews compressed for mobile app and web interface, assisting study triage without altering standard care workflow.

Performance

Retrospective study using 341 non-contrast CT scans from multiple U.S. hospitals showed sensitivity of 89.22% and specificity of 91.37% for detecting intracranial hemorrhage. Time to notification ranged from 50 to 126 seconds, substantially faster than standard of care (38.2 minutes). Performance met pre-specified goals, was stratified by ICH subtype, gender, age, and scan parameters, demonstrating robustness and safety equivalent to predicate device.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    4/27/2023

    3 months
  • 2

    FDA Approval

    7/27/2023

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