Viz ICH
Viz.ai, Inc.Viz ICH is an AI-based software tool designed to analyze non-contrast CT scans of the brain for signs of intracranial hemorrhage (ICH). When the software detects suspected ICH, it sends notifications to neurovascular or neurosurgical specialists, helping speed up patient care by alerting clinicians early. The system includes a backend server for image processing and a mobile app for reviewing images in a non-diagnostic way for quick assessment and communication.
Intended Use
Viz ICH is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow. It analyzes non-contrast CT images of the brain acquired in the acute setting and sends notifications of suspected intracranial hemorrhage.
Technology
The system includes a DICOM router and backend server. The backend server receives, stores, processes, and analyzes NCCT images using an AI algorithm to detect ICH. When suspected ICH is detected, notifications are sent to pre-determined specialists. The mobile application receives alerts and allows users to preview compressed images for informational purposes only, with no diagnostic use intended on the app.
Performance
Performance was evaluated retrospectively on 261 NCCT brain scans from two US clinical sites. The device achieved 93% sensitivity and 90% specificity for detecting ICH compared to neuro-radiologist ground truth. Time to alert specialists was on average 0.49 minutes, significantly faster than standard care at 38.2 minutes, demonstrating early clinical workflow involvement.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/30/2019
2 months - 2
FDA Approval
3/18/2020
Other devices from Viz.ai, Inc.
- Viz HDS, Viz Volume Plus, Viz ICH+2024 • 510K
- Viz HCM2023 • DE NOVO
- Viz AAA2023 • 510K
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