The FDA has issued an emergency use authorization (EUA) for Eko’s ECG-based low ejection fraction algorithm.
The AI model, developed as part of a collaboration with Mayo Clinic, received Breakthrough Device designation back in December 2019. This EUA was issued because of the importance the FDA sees in detecting signs of abnormal heart function during the ongoing COVID-19 pandemic.
“Early detection of heart failure patients can better inform treatments for these individuals at higher risk for severe illness from COVID-19,” Connor Landgraf, Eko’s CEO and co-founder, said in a prepared statement. “With the FDA’s EUA, Eko will be able to offer its low ejection fraction screening at Mayo Clinic immediately, the first step in expanding the offering to other providers on the Eko platform.”
“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,” Paul Friedman, MD, chair of the department of cardiovascular medicine at Mayo Clinic, said in the same statement. “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. 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.”
Full details of the FDA’s EUA can be read here.