qER-CTA (v1.0)
Qure.ai TechnologiesqER-CTA (v1.0) by Qure.ai Technologies is an AI-powered software designed to assist clinicians by automatically analyzing brain CT angiogram images to detect suspected large vessel occlusions (LVOs). It provides notifications to neurovascular specialists to prioritize and review cases promptly. This helps improve workflow efficiency and supports rapid clinical decision-making in acute stroke care, though it is not intended to replace full patient evaluation or be used for diagnostic purposes beyond notification.
Intended Use
Notification-only, parallel workflow tool using deep learning to analyze brain CT angiogram images for suspected large vessel occlusion (LVO) in adults to notify neurovascular specialists, independent of standard care workflow. Images can be previewed on mobile but not for diagnostic use beyond notification.
Technology
Software uses a deep learning algorithm to analyze brain CT angiogram images and provide case-level outputs for triage via PACS or mobile application. It operates as a parallel workflow tool, sending notifications for suspected LVO cases to neurovascular specialists, without altering original images or worklist order.
Performance
Clinical performance was validated with a standalone study of 584 head CTA scans, showing high accuracy for LVO detection with sensitivity 91.35%, specificity 91.86%, and AUC 0.959. Time to notification was 6.36 minutes on average. Software verification and validation testing confirmed it met performance and functional criteria.
Predicate Devices
No predicate devices specified
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