FDA clears Eko's stethoscope algorithms for AFib, heart murmur screening

Dive Brief:

Digital stethoscope maker Eko said Tuesday FDA gave 510(k) clearance to its artificial intelligence algorithms intended to help physicians identify atrial fibrillation (AFib) and heart murmurs during a standard physical exam.
The privately held, Berkeley, California-based company said the AFib and heart murmur applications are the first in a suite of cardiac screening algorithms it is developing to improve the detection of cardiovascular diseases.
Eko announced in December it received FDA's breakthrough device designation for an EKG-based algorithm it's developing to screen for heart failure.

Dive Insight:

Heart disease is the leading cause of death in the United States. Enabling doctors on the front lines to more accurately pinpoint specific, serious heart conditions with the ubiquitous stethoscope holds the promise of speeding diagnosis and treatment for patients. Heart murmurs can be an indication of valve disease, while AFib, an irregular rhythm, can cause life-threatening blood clots.

Eko said the algorithm, incorporated in its Duo stethoscope, detected AFib with 99% sensitivity and 97% specificity in a clinical study. Heart murmurs were identified with 87% sensitivity and 87% specificity, the company said. It contrasted those findings with a 2017 study published in the European Heart Journal that showed primary care physicians using traditional stethoscopes detected valve disease with 43% sensitivity and 69% specificity.

The algorithms use deep neural network models that have been trained and validated across multiple datasets to support their performance on real-world data, Eko said. The software also reports QRS duration, which can indicate a heart condition, and can identify tachycardia, an abnormally fast heart rhythm, and bradycardia, a slow heart rate.

Eko sells its Duo EKG and digital stethoscope for $349. Eko said that since it began selling its first device in 2015, its technology has been adopted in more than 4,000 healthcare facilities throughout the U.S. and Europe.

The company has its sights on expanding the algorithm’s reach into heart failure, a condition expected to affect 8 million Americans by 2030, per the American Heart Association.

In December, it received FDA’s breakthrough device designation to develop software, in a partnership with the Mayo Clinic, to detect reduced left ventricular ejection fraction using data collected by the Duo stethoscope. FDA breakthrough status can accelerate the regulatory review of devices that demonstrate the potential to address unmet medical needs for life-threatening diseases.

Eko announced in September it received $20 million in Series B funding, led by ARTIS Ventures, that it planned to put toward research, development and commercialization of its machine learning platform for cardiac screening and analysis. New and returning investors included 3M Ventures, Mayo Clinic, DigiTx Partners, NTT Venture Capital, Seraph Group and XTX Ventures.

Last March, Eko said it was working with Northwestern Medicine Bluhm Cardiovascular Institute to enroll 1,000 patients in a study of its platform for heart murmurs and valve disease.