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FDA issues emergency use authorization for algorithm designed to improve detection of heart failure during COVID-19
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The FDA granted Emergency Use Authorization to Eko, a digital health company, for the heart screening algorithm developed by Mayo Clinic. The AI-driven algorithm can detect weak heart pump, which is commonly detected by echocardiogram, a test that is not normally conducted during a physical exam, requires specially trained technicians to record, and requires prolonged contact with the patient.
"Given the danger COVID-19 poses to patients with a weak heart pump, it’s important that we rapidly identify these individuals early and monitor them closely. By embedding the heart failure screening AI into a quick, widely available, and safe test using existing medical devices, we can detect heart failure early and start appropriate treatments," said Dr. Paul Friedman, Chair of the Department of Cardiovascular Medicine, Mayo Clinic. "Additionally, for people with COVID-19, we may be able to identify when the virus causes the development of a weak heart pump quickly, safely, and easily using these AI tools."
Dr. Friedman led the team who developed the algorithm that was licensed to Eko.
The algorithm was first announced in a landmark publication in Nature Medicine in January 2019, describing for the first time the technology that permits a point of care ECG device combined with an AI algorithm to identify a low ejection fraction in patients.
For the latest updates on the COVID-19 pandemic, check the Centers for Disease Control and Prevention website. For more information and COVID-19 coverage, go to the Mayo Clinic News Network and mayoclinic.org.
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