Viz ANEURYSM, Viz ANX
Viz.ai, Inc.Viz ANEURYSM is an AI-powered software that analyzes CT angiogram images of the head to detect suspected aneurysms of at least 4mm. It helps radiologists prioritize patient studies by flagging and highlighting cases with suspected aneurysms in a standalone application. This assists in faster triage and review, improving workflow efficiency while ensuring diagnostic decisions remain with the radiologist.
Intended Use
Viz ANEURYSM (Viz ANX) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected aneurysms during routine patient care.
Technology
Viz ANEURYSM uses an AI machine learning algorithm to analyze head CTA images for aneurysms. The software runs on a backend server and prioritizes patients in a standalone mobile application for triage. It generates compressed preview images for non-diagnostic review. The device does not alter original images and serves as an aid for triage alongside standard of care.
Performance
Clinical testing on 315 CTA head scans showed 93% sensitivity and 89% specificity for detecting aneurysms ≥4mm. The device had an area under the ROC curve of 0.967. In 20 cases with known standard of care time-to-notification, Viz ANEURYSM notifications were significantly faster (mean ~3.7 minutes) versus standard workup (~43.6 minutes). Stratified analyses indicated consistent performance across sites, age groups, sex, and imaging parameters.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/4/2021
4 months - 2
FDA Approval
2/18/2022
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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