Viz.ai Receives CE Mark to Bring Life-saving Stroke Care to Europe

SAN FRANCISCO--(BUSINESS WIRE)--Viz.ai has been awarded a CE Mark for its artificial intelligence (AI) powered stroke care software, affirming its conformity with European health, safety and environmental protection standards for products sold within the European Economic Area. Viz.ai’s intelligent care coordination system connects multidisciplinary care teams earlier, coordinates care and puts patients first with the company’s software suite, which has been clinically proven to synchronize stroke care, decrease time to treatment and greatly improve patient outcomes.

In the European Union (EU), stroke is the second most common cause of death and a leading cause of adult disability, but only an estimated 1.9 percent receive a potentially lifesaving, minimally invasive endovascular procedure that removes blood clots. Viz.ai’s flagship solution, Viz LVO, uses AI to automatically detect suspected large vessel occlusion (LVO) strokes on computed tomography angiography (CTA) imaging and directly alert on-call stroke specialists about potentially treatable patients in a standalone or multi-hospital network.

“Minutes matter when you’re having a stroke, which is why Viz.ai is dedicated to reducing time to treatment and improving patient outcomes through improved care coordination,” said Chris Mansi, co-founder and CEO of Viz.ai. “The CE Mark allows us to bring our leading AI software to the EU, significantly expanding the number of patients we can help get access to life saving therapy.”

Viz.ai is the most studied stroke workflow software available today. A recent, large, real-world multi-center study using Viz.ai found a median time-to-notification of five minutes and 45 seconds across all of the sites involved when using Viz LVO. In the study, containing the largest health AI data set to date, Viz LVO achieved 96 percent sensitivity and 94 percent specificity in identifying LVOs in 2,544 consecutive patients from 139 hospitals using scanners from multiple manufacturers. Faster triage with Viz LVO enables the identification and treatment of more patients who are eligible for thrombectomy, which improves patient outcomes and reduces the chances of long-term disability.

About Viz.ai, Inc.

Viz.ai is the leader in AI-driven intelligent care coordination. Viz.ai’s mission is to fundamentally improve how healthcare is delivered in the world, through intelligent software that promises to reduce time to treatment, improve access to care, and increase the speed of diffusion of medical innovation. Viz.ai’s flagship product, Viz LVO, leverages advanced deep learning to communicate time-sensitive information about stroke patients straight to a specialist who can intervene and treat.

In February 2018, the U.S. Food and Drug Administration (FDA) granted a De Novo clearance for Viz LVO, the first-ever computer-aided triage and notification software. Viz.ai announced its second FDA clearance for Viz CTP through the 510(k) pathway, offering healthcare providers an important tool for automated cerebral perfusion image analysis. A third FDA clearance was granted in 2020 for Viz ICH, which uses AI to automatically detect suspected intracranial hemorrhage on CT imaging. In 2020, CMS granted Viz.ai the first New Technology Add-on Payment (NTAP) for artificial intelligence software for Viz LVO.

Viz.ai is located in San Francisco and Tel Aviv and backed by leading Silicon Valley investors, including Kleiner Perkins, Google Ventures, Greenoaks, CRV, Threshold Ventures, Innovation Endeavors, Susa Ventures, Scale Venture Partners and Insight Partners.