Automated algorithm to detect right ventricle dilation gains FDA 510(k) clearance
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Viz.ai announced it received FDA 510(k) clearance for its automated right ventricle/left ventricle ratio algorithm for use in patients with suspected pulmonary embolism.
The automated algorithm (Viz.ai automated CT scan clot detection system) is designed to quickly and accurately provide the ratio of the maximum right ventricle diameter compared with maximum left ventricle diameter in patients with pulmonary embolism, according to a company press release.
The company’s pulmonary embolism solution uses deep learning to identify suspected central and segmental pulmonary emboli in less than 2 minutes and, with integration of the right ventricle/left ventricle ratio algorithm, may identify potential right ventricle dilation, according to the release.
“The Viz.ai automated CT scan clot detection system improves diagnostic acumen and expedites care for patients with acute pulmonary embolism,” Kenneth Rosenfield, MD, MHCDS, FACC, FAHA, MSCAI, section head of vascular medicine and intervention at Massachusetts General Hospital, said in the release. “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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