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Digital health company Eko has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its ECG-based algorithm for detecting cardiac dysfunction in Covid-19 patients.
The EUA enables healthcare system to use the AI algorithm to analyse a standard 12-lead ECG. It is said to be an easily accessible and painless test to detect the risk of a weakened heart pump.
Developed through a partnership with the Mayo Clinic, the Eko Electrocardiogram (ECG) Low Ejection Fraction Tool secured FDA breakthrough device designation in December last year. Its regulatory review was further expedited due to its application in identifying patients with abnormal heart function during the pandemic.
Furthermore, it will help in detecting underlying cardiac conditions that may affect clinical management of the infection in patients having or suspected of having Covid-19.
The company noted that patients with cardiovascular disease have a higher risk of death from Covid-19 compared to those with healthy hearts.
According to the American College of Cardiology, patients with pre-existing cardiovascular disease are estimated to have a 10.5% case fatality rate due to Covid-19. The infection may also directly cause weakness in heart muscles.
Eko co-founder and CEO 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 authorisation, 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.”