Viz.ai’s Automated RV/LV Analysis Algorithm Receives FDA Clearance for Viz PE Solution

September 1, 2022—Viz.ai announced it has received FDA 510(k) clearance for an automated RV/LV ratio algorithm as a component of the Viz Pulmonary Embolism (PE) solution 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).

The Viz PE solution was launched in November 2021. Viz PE is designed to identify suspected central and segmental PE in < 2 minutes.

According to the company, integrating the RV/LV algorithm provides the Viz PE solution with an automated assessment of potential RV dilation. This information, delivered quickly to the care team, further ensures that the right clinical decision is made at the right time—wherever the patient resides in the health care system—for quick and appropriate care.

Interventional cardiologist Kenneth Rosenfield, MD, who is Section Head of Vascular Medicine and Intervention at Massachusetts General Hospital in Boston, Massachusetts, and cofounder of the PERT Consortium, commented in the company’s press release, “The Viz.ai automated CT scan clot detection system improves diagnostic acumen and expedites care for patients with acute PE. But the true killer in patients with PE is the failure of the right heart.”

Dr. Rosenfield continued, “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.”