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Intended Use

Heuron ICH is radiological computer-aided triage and notification software for analysis of non-contrast head CT images in adults or transitional adolescents aged 18 and older. It aids appropriately trained medical specialists and hospital networks in streamlining workflow by identifying and communicating suspected positive findings of Intracranial hemorrhage (ICH).

Technology

Heuron ICH uses an AI convolutional neural network (CNN) trained with RSNA Brain CT Hemorrhage Challenge 2019 dataset to analyze DICOM format non-contrast CT images automatically received from hospital PACS systems. It registers with PACS, authenticates incoming images, analyzes them in sequence for suspected ICH, and sends notifications with compressed preview images via app, email, or SMS. It does not alter original images nor provide segmentation or intermediate outputs.

Performance

Performance was evaluated in a retrospective multi-center study with 600 NCCT head images from three US hospitals with roughly equal positive and negative cases. Sensitivity was 86.3% (95% CI: 81.9-90.3) and specificity 87.6% (95% CI: 83.9-91.0), exceeding acceptance criteria of 80%. Time-to-notification averaged 60.3 seconds, significantly shorter than standard of care. AUC was 0.945 compared to radiologist consensus.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    9/28/2023

    7 months
  • 2

    FDA Approval

    5/15/2024

Other devices from Heuron Co., Ltd.

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