Viz.ai obtains CE mark for AI-based stroke care software

15 July 2021


stroke

Viz.ai has received CE mark to market its artificial intelligence (AI)-driven stroke care software, Viz LVO, in the European Economic Area.

The intelligent care coordination system links a variety of care teams, synchronises care and prioritises patients using its software suite. The suite can coordinate stroke care, lower time to treatment and enhance patient outcomes, clinical data shows.

Viz LVO leverages AI to identify suspected large vessel occlusion (LVO) strokes on computed tomography angiography (CTA) images.

It then notifies on-call stroke experts about the patients who could be treated in a standalone or multi-hospital setting.

Viz.ai co-founder and CEO Chris Mansi said: “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.

“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.”

In a large, real-world multi-centre study, Viz LVO demonstrated a median time-to-notification of five minutes and 45 seconds across all trial centres.

Furthermore, the software had a sensitivity of 96% and specificity of 94% in detecting LVOs in 2,544 patients from 139 hospitals while utilising scanners from different companies.

The company noted that quicker triage with Viz LVO facilitates the detection and treatment of more people who require thrombectomy, which enhances patient outcomes and lowers long-term disability risks.

Stroke is the second common cause of mortality and a major cause of disability in adults in the European Union (EU). Viz.ai noted that only about 1.9% of patients get potentially lifesaving, less invasive endovascular procedure to remove blood clots.

Viz.ai received a de novo clearance for Viz LVO from the US Food and Drug Administration (FDA) in February 2018.

In July 2019, Medtronic agreed to distribute Viz.ai’s software across US centres

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Published on Medicaldevice-network.com