CADence Ironman (PRNewsfoto/AUM Cardiovascular, Inc.)

Aum Cardiovascular has received FDA clearance for Cadence, a device that uses acoustic and ECG signals to non-invasively and automatically screen for heart disease.

Cadence is a hand-held device designed by Aum Caardiovascular that pairs the auscultation of cardiac sounds with ECG signals to screen for cardiac disease. Data is collected by applying the device to a patient’s chest in four positions including subxyphoid, parasternal, and mid-clavicular – positions used for a typical echocardiography exam as well as bedside auscultation. The data collected is sent to a central server for analysis and results are transmitted back to the physician.

While the most intuitive use for CADence would be for detection of valvular disease, the FDA clearance is actually for risk stratification of patients presenting with chest pain. According to Aum, CADence is “indicated for use in-office for the noninvasive functional assessment of patients presenting with chest pain and two or more coronary artery disease risk factors, to identify patients with obstructive coronary artery disease.”

The first clinical study, performed out of UCLA, involved 1,000+ patients presenting with chest pain. With the big caveat that the results are unpublished, they claim to be equivalent to a nuclear stress test for detection of obstructive coronary disease in this population. In a moderate risk population, they claim a sensitivity and specificity of 81% and 83% respectively. Particularly importantly, they claim an 80% and 83% positive and negative predictive value.

There are a number of digital health devices focused on cardiovascular health. AliveCor’s Kardia devices capture single-lead ECG data and are perhaps the best studied digital-health devices, with evaluated applications including screening for atrial fibrillation and monitoring QT interval changes. The Eko stethoscope, which is more similar to CADence, is an electronic stethoscope that captures acoustic data as well, primarily for education as well as telehealth and virtual consults. And their recently announced Eko Duo device pairs that data with ECG signals as well, though the use case doesn’t appear to be as well-studied as CADence.

It’s interesting to speculate how the kind of data they collect applies to the evaluation of chest pain. Certainly, signs of heart failure like a gallop or rales would be concerning for an acute coronary syndrome. Other factors, like murmurs to suggest valvular calcification or stenosis in the subclavian artery or abdominal aorta, may further suggest a higher risk patient.

While CADence is one of the more intriguing digital health devices we’ve seen come to market, we’ll have to wait to see the actual study results to understand whether it’s a device worth investing in.

Sources: Aum Cardiovascular, Press Release