Rapid NCCT Stroke
iSchemaView, Inc.Rapid NCCT Stroke is software that uses artificial intelligence to analyze non-contrast head CT scans and quickly notify clinicians about suspected areas of brain hemorrhage or large vessel blockage. This helps prioritize urgent cases and speeds up patient care, but it is intended to assist—not replace—clinical judgment and diagnosis.
Intended Use
Radiological computer aided triage and notification software for nonenhanced head CT images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of Intracranial Hemorrhage and large vessel occlusion of the ICA and MCA-M1.
Technology
AI/ML neural network software module operating on NCCT images with algorithms for ICH and LVO detection, integrated within the Rapid Platform for image processing, notification, and workflow prioritization in parallel with standard of care.
Performance
Performance evaluation was conducted in a retrospective, blinded, multicenter multinational study of 254 cases showing sensitivity and specificity exceeding prespecified goals for ICH detection (Se 0.962, Sp 0.974) and LVO detection (Se 0.635, Sp 0.951). The device also demonstrated faster notification times (~2.5 minutes) compared to standard of care (~59 minutes).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/22/2022
5 months - 2
FDA Approval
3/2/2023
Other devices from iSchemaView, Inc.
- Rapid ASPECTS (v3)2024 • 510K
- Rapid (6.0)2024 • 510K
- Rapid SDH2023 • 510K
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