FDA Clears Eko’s Murmur Analysis Software for Detecting Valvular Heart Disease for Adult and Pediatric Patients

July 12, 2022—Eko, an Oakland, California–based digital health company focused on heart and lung disease detection, announced that the FDA has cleared its Eko Murmur Analysis Software (EMAS) for detecting and characterizing murmurs found in adults and pediatric patients.

The next generation of Eko’s murmur detection capabilities allows the company’s smart stethoscope to identify and differentiate, between innocent and structural, heart murmurs indicative of valvular heart disease.

According to the company, by combining murmur analysis artificial intelligence with its digital stethoscopes, Eko has transformed the traditional stethoscope into an objective, low-cost, and scalable screening tool that can identify significant structural heart disease in seconds.

The EMAS algorithm provides overall sensitivity of 85.6% and specificity of 84.4%, improving health care providers’ ability to identify valvular heart disease accurately and consistently. Additional analysis showed that among adults aged ≥ 18 years, the EMAS algorithm identified structural murmurs with a sensitivity of 90.2% and specificity of 90.6%. By contrast, when using traditional stethoscopes to detect significant valvular heart disease, general practitioners were found to have a sensitivity of 44% and specificity of 69%.

“Combining pathologic murmur detection with the stethoscope, a tool already deeply embedded in the practice of medicine, will allow for more accurate and efficient screening of heart valve disease in the community,” commented Patrick McCarthy, MD, in the company’s press release.

Dr. McCarthy, who is Executive Director of the Bluhm Cardiovascular Institute at Northwestern Medicine in Chicago, Illinois, continued, “Eko’s platform will help uncover early valvular heart disease in millions of people worldwide who may otherwise be missed and make a significant impact on our ability to treat patients with life-saving interventions.”

As summarized in the company’s press release, EMAS is a cloud-based machine learning algorithm that analyzes heart sounds, phonocardiogram, and electrocardiogram signals (when available), captured using Eko’s smart stethoscopes. The software uses several methods to interpret the acquired signals, including signal processing and convolutional neural networks. The database used in the training and testing of EMAS is one of the largest repositories of clinically validated heart sounds.

EMAS is FDA cleared to automatically detect murmurs that may be present and the murmur timing and character, including S1, S2, innocent heart murmurs, structural heart murmurs, and the absence of a heart murmur. The software is not intended as a sole means of diagnosis and is for use in environments where health care is provided by clinicians. The interpretations of heart sounds offered by the software are meant only to provide decision support to the clinician, who may use the result in conjunction with their own evaluation and clinical judgment. EMAS is intended for use on pediatric and adult patients, advised the company.