Eko announced today that the FDA has issued the company an emergency use authorization (EUA) for its novel ECG-based algorithm designed to provide an easily accessible, rapid screening test for low ejection fraction (low EF), a weak heart pump.
Awarded an FDA breakthrough device designation in December 2019, the algorithm’s regulatory review has been further accelerated due to its potential to help identify patients with abnormal heart function during the COVID-19 pandemic, according to the Oakland, Calif,.-based company.
A recent study published in the Journal of the American College of Cardiology estimates that patients with pre-existing cardiovascular disease have a 10.5% case fatality rate due to COVID-19, significantly higher than those without such conditions. COVID-19 infection may also directly cause heart muscle weakness. The EUA allows healthcare providers to use Eko’s AI algorithm to analyze a standard 12-lead ECG to assess the risk of a weakened heart pump.
Eko’s low ejection fraction algorithm employs a deep neural network developed in collaboration with Mayo Clinic.
“Early detection of heart failure patients can better inform treatments for these individuals at higher risk for severe illness from COVID-19,” said Eko CEO Connor Landgraf in a news release. “With the FDA’s emergency use authorization, Eko will be able to offer its low EF screening at Mayo Clinic immediately, the first step in expanding the offering to other providers on the Eko platform.”
Heart failure affects about 5.7 million people in the U.S. alone and is most 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. Because of limited access to echocardiography, especially during the COVID-19 pandemic, and because many patients with reduced heart function do not have symptoms, or have symptoms that are attributed to COVID-19, heart failure is frequently diagnosed late, making life-prolonging treatment more challenging.
“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,” said Dr. Paul Friedman, chair of the Department of Cardiovascular Medicine, Mayo Clinic. “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.”
Mayo Clinic and Friedman have a financial interest in the technology. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research, according to Eko.