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FDA clears new algorithm for identifying pulmonary embolism – Mass Device

The Medical Device Business Journal — Medical Device News & Articles | MassDevice
September 1, 2022 By
San Francisco-based designed its algorithm to quickly and accurately measure the diameter of the ventricles of the heart. The measurements provide the ratio of the maximum right ventricle (RV) diameter versus left ventricle (LV). Automating this risk indicator for pulmonary embolism (PE) enables care teams to respond quickly. launched Viz PE in November 2021. It uses deep learning to identify suspected central and segmental pulmonary emboli in under two minutes. The integration of the new RV/LV algorithm adds an automated assessment of potential right ventricle dilation.
The company that this enables care teams to make the right decision at the right time. No matter where the patient resides in the healthcare system, this ensures quick and appropriate care, said.
“The 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. “But the true killer in patients with PE is failure of the right heart. … The Viz PE Solution now includes both detection of a 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.”’s RV/LV algorithm adds to its portfolio of FDA-cleared AI-powered offerings. Its Viz Platform saves time and improves patient outcomes. It also offers 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, “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.”
Filed Under: 510(k), Business/Financial News, Cardiovascular, Digital Health, Food & Drug Administration (FDA), Health Technology, Regulatory/Compliance, Software / IT, Vascular
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