FDA clears Viz.ai’s right-to-left ventricle ratio algorithm

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Viz.ai has received US Food and Drug Administration (FDA) 510(k) clearance for an automated right ventricle-to-left ventricle (RV/LV) ratio algorithm, a new component of its 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 RV diameter versus that of the LV. Automating this patient risk indicator will enable care teams to respond more quickly than before, Viz.ai said in a press release.

Launched in November 2021, Viz PE uses deep learning to identify suspected central and segmental pulmonary emboli in under two minutes. With the integration of the RV/LV algorithm, the tool now includes an automated assessment of potential RV dilation.

“The Viz.ai automated computed tomography (CT) scan clot detection system improves diagnostic acumen and expedites care for patients with acute pulmonary embolism,” said Kenneth Rosenfield, (Massachusetts General Hospital, Boston, USA), co-founder of the PERT Consortium—a network of multidisciplinary pulmonary embolism response teams. “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.”


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