WSJ Venture Capital - FDA Approves Eko Devices’ Algorithms for Detecting Heart Conditions

Brian Gormley

January 28, 2020

Eko Devices Inc., which raised $20 million in venture capital in September, has secured U.S. regulatory clearance for algorithms designed to improve screening for two common heart conditions as digital-health startups push into the cardiovascular-disease sector.

Digital-health startups are using new algorithms and software that can be applied to data collected from patients via mobile phones or other devices. In Eko’s case, its goal is to improve the detection of heart problems that can lead to strokes and other conditions.

The benefits of improved detection could be wide-reaching, since heart disease is the leading killer in the U.S., causing 647,000 deaths a year, according to the Centers for Disease Control and Prevention.

Eko was formed in 2013 and previously secured U.S. Food and Drug Administration clearance for its DUO product, which combines a digital stethoscope and electrocardiogram in a hand-held device, and software used with it.

Now the FDA has cleared Eko algorithms that alert doctors to heart murmurs and atrial fibrillation during physical exams.

Abnormal heart murmurs in adults are related to heart-valve problems, according to the American Heart Association. Atrial fibrillation, or abnormal beating in the heart’s upper chambers, increases a person’s risk of stroke, according to the CDC.

Eko said it is able to identify heart murmurs with 87% accuracy. A 2017 study published in European Heart Journal reported that clinicians using conventional stethoscopes correctly identified 43% of people who had significant valvular heart disease.

The Berkeley, Calif.-based company now plans to make its algorithms for detecting heart murmurs and atrial fibrillation available to thousands of physicians using its DUO technology, said co-founder and Chief Executive Connor Landgraf.

Eko also plans to pursue FDA clearance for an ECG-based algorithm to help screen for heart failure and ultimately plans to provide clinicians a suite of algorithms for different types of cardiovascular disease, Mr. Landgraf said.

Other companies that have developed digital technologies for heart conditions include AliveCor Inc., whose investors include Khosla Ventures. AliveCor has FDA clearance for KardiaMobile, a device that works with a smartphone to provide detection of atrial fibrillation as well as bradycardia, a condition in which heart rate is too slow, and tachycardia, or heartbeat that is too fast.

In addition to cardiovascular disease, Eko sees opportunities in applying its technology to lung conditions such as chronic obstructive pulmonary disease and pneumonia, Mr. Landgraf said.

Artis Ventures led Eko’s financing round in September, which included participation from 3M Ventures, DigiTx Partners, the Mayo Clinic, NTT Venture Capital, Seraph Group and XTX Ventures.

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