Gets FDA Clearance for New RV/LV Ratio Algorithm

The automated measurement of heart ventricle diameters and detection of potential dilation in the right ventricle may facilitate quicker intervention in cases of pulmonary embolism.

The Food and Drug Administration (FDA) has granted 510(k) clearance for a new artificial-intelligence (AI)-powered RV/LV ratio algorithm, the latest addition to the Viz PE (pulmonary embolism) solution platform from

Through automated measurement of the diameters of heart ventricles, the RV/LV ratio algorithm enables clinicians to quickly determine the ratio of maximum right ventricle diameter to that of the left ventricle, according to

Kenneth Rosenfield, M.D., said the latest addition to the Platform is a significant advance in facilitating timely risk stratification and care in patients with pulmonary embolism (PE). The algorithm’s ability to assess potential issues with right ventricle dilation is a key benefit, according to Dr. Rosenfield, an interventional cardiologist and section head of Vascular Medicine and Intervention at the Massachusetts General Hospital in Boston.

“The true killer in patients with (pulmonary embolism) 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 heart,” said Dr. Rosenfield. “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.”