FDA Approves AI Algorithms for Detecting Heart Murmurs and Atrial Fibrillation (AFib)

The FDA has granted clearance to a suite of algorithms developed by Eko, designed to enhance heart condition screenings during routine physical exams in the U.S. These algorithms can effectively detect heart murmurs, which may indicate valvular or structural heart issues, and atrial fibrillation (AFib), a condition linked to blood clots, strokes, and heart failure.

Eko claims that its AI algorithms identify heart murmurs with 87% sensitivity and 87% specificity. In contrast, primary care physicians, without AI assistance, achieved only 43% sensitivity and 69% specificity, according to a study published in the European Heart Journal. Furthermore, when used with the Eko DUO stethoscope, the AI detected AFib with an impressive 99% sensitivity and 97% specificity.

Dr. Patrick McCarthy, Executive Director of the Bluhm Cardiovascular Institute at Northwestern Medicine and member of Eko's Scientific Advisory Board, stated, "Two centuries after its invention, the stethoscope remains a frontline tool for detecting cardiovascular disease. Eko's AI algorithms will significantly enhance clinicians' ability to interpret sounds, recognize arrhythmias, and identify heart murmurs during physical exams."

This FDA clearance allows Eko to implement its murmur and AFib-detection algorithms using their existing digital stethoscopes. Additionally, in December, the FDA awarded another Eko algorithm "breakthrough status," expediting its approval process. This algorithm utilizes ECG data to assess Left Ventricular Ejection Fraction (LVEF), a key metric in diagnosing heart failure. Once approved, Eko's digital stethoscopes will empower healthcare providers to screen for heart failure, valve disease, and AFib, all during routine check-ups.

With these advancements, Eko is set to revolutionize cardiovascular care at the point of care, ensuring more accurate assessments and early detection of heart conditions.