AI software to detect strokes gets FDA clearance

FDA approved Viz LVO Stroke Platform, an AI-based triage software from Viz.ai Inc. (San Francisco, Calif.), to detect large vessel occlusion (LVO) strokes in computed tomography (CT) images of the brain. The approval, which came via FDA's de novo premarket review pathway, opens up a new regulatory classification under the 510(k) pathway for future computer-aided triage software devices with the same medical imaging intended use.

Viz LVO Stroke Platform alerts a neurovascular specialist via text notification when it identifies a suspected blockage during analysis. In support of the application, Viz.ai submitted to FDA data from a 300-patient retrospective reader and performance study comparing the software's image analysis algorithm from 300 CT images to standard of care. The software identified LVOs and alerted specialists with 90% accuracy. The median scan-to-notification time was less than 6 minutes, and the software notified specialists faster in more than 95% of cases, saving an average of 52 minutes...