The FDA authorization will enable the healthcare providers to use Eko’s AI algorithm to assess the risk of a weakened heart pump
US-based digital medical devices company Eko has received the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its novel ECG-based algorithm.
The company said that its new algorithm has been designed to provide rapid screening test for low ejection fraction, a weak heart pump, and improve the heart failure detection during Covid-19 pandemic.
In addition, the algorithm was granted FDA Breakthrough Device designation in December 2019.
Eko CEO and co-founder Connor Landgraf said: “Early detection of heart failure patients can better inform treatments for these individuals at higher risk for severe illness from COVID-19.
“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.”
Eko algorithm identifies patients with abnormal heart function during the Covid-19 pandemic
The algorithm is software as a medical device that detects the low ejection fraction of a patient based on the analysis of ECG signals at the point of care.
The company said that its new low ejection fraction algorithm leverages a deep neural network developed in collaboration with Mayo Clinic.
The new algorithm will be part of the Eko AI, a cloud-based software application program interface (API) that can be electronically interfaced and perform analysis with data transferred from 12-lead ECG devices.
The FDA authorisation will enable the healthcare providers to use Eko’s AI algorithm to analyse a standard 12-lead ECG, an easily accessible test to assess the risk of a weakened heart pump.
Mayo Clinic cardiovascular medicine department Chair Paul Friedman said: “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. 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.”