Viz.ai’s LVO Software Receives CE Mark Approval for Stroke Care

June 30, 2021—Viz.ai announced that the company’s artificial intelligence (AI)–powered stroke-care software has earned European CE Mark approval. Viz.ai’s intelligent care coordination system is intended to connect multidisciplinary care teams and coordinate care with the company’s software suite, which synchronizes stroke care, decreases time to treatment, and improves patient outcomes.

Viz.ai’s flagship product, Viz LVO, uses AI to automatically detect suspected large vessel occlusion (LVO) strokes on CT angiography and to directly alert on-call stroke specialists about potentially treatable patients in a standalone or multihospital network. In February 2018, the FDA granted de novo clearance for commercialization of the Viz LVO computer-aided triage and notification software in the United States.

According to the company, faster triage with Viz LVO enables the identification and treatment of more patients who are eligible for thrombectomy, thereby improving patient outcomes and reducing the chances of long-term disability. In a recent, large, real-world multicenter study, the Viz LVO stroke workflow software demonstrated a median time-to-notification of 5 minutes and 45 seconds across all sites. Additionally, Viz LVO achieved 96% sensitivity and 94% specificity in identifying LVOs in 2,544 consecutive patients from 139 hospitals using scanners from multiple manufacturers, stated Viz.ai.