13 May 2020 - - The US Food and Drug Administration has issued US-based screening and telehealth solutions developer Eko an Emergency Use Authorization for its novel ECG-based algorithm that can provide an easily accessible, rapid screening test for low ejection fraction (low EF), a weak heart pump, the company said.

Awarded an FDA Breakthrough Device designation in December 2019, the algorithm's regulatory review has been further accelerated due to its potential to assist providers in identifying patients with abnormal heart function during the COVID-19 pandemic.

It is known that patients with cardiovascular disease have a much greater risk of death from COVID-19 than those with normal hearts. Patients with pre-existing cardiovascular disease are estimated by the American College of Cardiology to 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 Emergency Use Authorization allows healthcare providers to use Eko's AI algorithm to analyze a standard 12-lead ECG, an easily accessible and painless test to assess the risk of a weakened heart pump.

Heart failure affects about 5.7 m people in the US 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.

Eko's low ejection fraction algorithm employs a deep neural network developed in collaboration with Mayo Clinic.

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.

Mayo Clinic and Dr. Friedman have a financial interest in the technology referenced in this release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research.

The algorithm is software as a medical device that detects whether a patient has an LVEF less than or equal to 40% based upon the analysis of ECG signals at the point of care.

It analyses a collected ECG, and within seconds displays a binary prediction of the likelihood of LVEF less than or equal to 40% on a smartphone, tablet, or PC device.

The algorithm will be part of Eko AI, a cloud-based software application program interface that allows a user to upload 12-lead ECG data for analysis. The API can be electronically interfaced and perform analysis with data transferred from 12-lead ECG devices.

Eko is privately-held and headquartered in Oakland, California.