CuraRad-ICH
CuraCloud Corp.CuraRad-ICH is an AI-powered software that helps radiologists quickly identify and prioritize head CT scans that may show acute intracranial hemorrhage (bleeding in the brain). By automatically analyzing CT images, it assists in faster diagnosis and treatment decisions to improve patient outcomes.
Intended Use
A software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage.
Technology
The core technology is a deep learning algorithm trained on non-contrast head CT scans with expert-labeled ICH ground truth. It uses an end-to-end trainable 3D classification framework for automatic ICH detection and integrates with PACS/worklist systems to triage cases.
Performance
Clinical validation with 388 CT studies showed 90.6% sensitivity and 93.1% specificity in detecting ICH. Performance was consistent across slice thickness, detector rows, and scanner manufacturers. Average processing time per study was 43 seconds.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/9/2019
8 months - 2
FDA Approval
4/13/2020
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