Viz.ai Receives FDA 510(k) Clearance for Automated RV/LV Analysis Algorithm

Part of the Viz PE Solution, new algorithm flags key patient risk indicator of pulmonary embolism severity

Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for an automated RV/LV ratio algorithm, a seamless new component of the Viz PE Solution. The algorithm is designed to quickly and accurately measure the diameter of the ventricles of the heart to provide the ratio of the maximum right ventricle (RV) diameter versus that of the left ventricle (LV). Automating this key patient risk indicator will enable care teams to respond more quickly than before.

Diagnosis and care coordination for patients suffering from PE requires fast multi-disciplinary communication for risk stratification and decision making. Launched in November 2021, Viz PE uses deep learning to identify suspected central and segmental pulmonary emboli in under two minutes.¹ With the integration of the RV/LV algorithm, the proven solution now includes an automated assessment of potential right ventricle dilation. Delivered quickly to the entire care team on the Viz PE Solution, the information further enables care teams to ensure that the right clinical decision is made at the right time – no matter where the patient resides in the healthcare system – to ensure quick and appropriate care.

“The Viz.ai automated CT scan clot detection system improves diagnostic acumen and expedites care for patients with acute pulmonary embolism,” said Dr. Kenneth Rosenfield, Interventional Cardiologist, Section Head of Vascular Medicine and Intervention at Massachusetts General Hospital and co-founder of the PERT Consortium^TM. “But the true killer in patients with PE is failure of the right heart. With this clearance, the Viz PE Solution now includes both detection of clot in the lungs and degree of strain on the right heart. This will enable clinicians to quickly triage patients and treat them appropriately, by providing a powerful tool for early detection and risk stratification. This expedited critical decision-making will undoubtedly save lives.”

The RV/LV ratio algorithm is another of the fast-growing number of FDA cleared AI algorithms on the enterprise wide Viz Platform, which is clinically validated and proven to save time and improve patient outcomes and access to care across more than 1,200 health systems in the US and EMEA.

“With AI-powered enhanced image interpretation that dramatically improves the quality and speed of mobile image viewing – and caregiver communication – Viz PE already helps identify suspected pulmonary embolisms in under two minutes,” said Jayme Strauss, chief clinical officer, Viz.ai. “The addition of the RV/LV algorithm is expected to further aid care teams to quickly make the right clinical decision for their patients, improving outcomes and saving lives.”

About Viz.ai, Inc.

Viz.ai, located in San Francisco, Tel Aviv, Portugal and Amsterdam, pioneered the use of AI algorithms and machine learning to increase the speed of diagnosis and care for a variety of acute and emergent diseases across hospitals and health systems. The Viz Platform is a transformative, intelligent care coordination solution that unifies synchronized care collaboration, high fidelity mobile image viewing, automated workflows and improved visibility at decision-making moments. Viz.ai’s comprehensive neurovascular and vascular AI platform is clinically proven to save time and improve patient outcomes and access to care and is used in more than 1,200 hospitals in the US and EMEA. Viz.ai’s life science portfolio expands the power of the AI-powered Viz Platform to pharmaceutical and medical device companies who are leaning into digital transformation to bring life-saving therapies to market more efficiently. The company was named to the Forbes 2021 Next Billion-Dollar Startups list of the 25 fastest-growing venture-backed startups and has been on the Forbes AI 50 list for three consecutive years. For more information visit viz.ai.

¹ FDA Letter K210237

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