Viz LVO
Viz.ai
The first computer-aided triage and notification device authorized by the FDA. Analyzes CT angiography for suspected large vessel occlusion and pushes a mobile alert to the stroke team in parallel with the standard radiology workflow.
At A Glance
- Manufacturer
- Viz.ai
- Medical specialty
- Radiology
- Clearance route
- De Novo
- Year authorized
- 2018
- Modality
- CT angiography
- Role in workflow
- Triage and notification
Viz LVO created the CADt regulatory category. Before it, there was no classification for software whose entire clinical claim was speed of notification rather than accuracy of interpretation, so the FDA authorized it through De Novo and wrote the controls that later triage devices now cite as their predicate.
The mechanism is deliberately parallel rather than sequential. The alert goes to the interventionalist at the same time the study enters the radiologist queue, which is what compresses door-to-puncture time in a transfer network.
Where It Is Used
- Large vessel occlusion detection on CTA
- Parallel notification of the interventional team
- Transfer coordination between spoke and hub hospitals
Limitations Worth Knowing
Sensitivity for proximal occlusions is considerably better than for distal ones, and the device is indicated for suspected LVO, not for ruling it out. A negative result is not a clearance to stand the team down. The reported time savings also come largely from network coordination studies, so a single-site hospital with an in-house interventional team will not see the same effect that a spoke-to-hub transfer network reports.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.