FDA approves Eko Health’s Low EF detection AI for detecting heart failure

Eko Health, recognized for its utilization of artificial intelligence (AI) in the early detection of heart and lung conditions, has revealed that its Low EF (ejection fraction) detection AI, integrated into the Eko Stethoscope, has received FDA clearance.

"For the first time, United States physicians can now identify Low EF, a crucial heart failure indicator, in just 15 seconds using an Eko stethoscope during a routine physical examination," stated a spokesperson from Eko Health. This advancement signifies a momentous medical breakthrough and heralds a new era in cardiovascular disease detection.

"In the US, more than 6 million individuals grapple with heart failure, with half of them suffering from heart failure with reduced ejection fraction (HFrEF) — a condition characterized by the heart's ineffectiveness in pumping blood," revealed recent statistics.

Traditional tools for heart failure detection, like echocardiography, are often unavailable in primary care settings due to cost, specialized training requirements, and time constraints.

Consequently, numerous heart failure cases remain undiagnosed until symptoms necessitate specialist or emergency hospital visits, resulting in poorer patient outcomes and increased healthcare costs. Eko's Low EF AI disrupts this status quo by integrating swift and accessible low ejection fraction detection into stethoscope examinations on the front lines of care.

"The capacity to identify a concealed, potentially life-threatening heart condition using a tool familiar to primary care and subspecialist clinicians — the stethoscope — has the potential to prevent hospitalizations and adverse events," affirmed Paul Friedman, MD, Chair of the Department of Cardiovascular Medicine at Mayo Clinic in Rochester, Minnesota. "Crucially, since a stethoscope is compact and portable, this technology can be utilized in urban and remote locations, hopefully addressing care in underserved areas."

The Low EF AI will be integrated into Eko’s SENSORA Cardiac Early Detection Platform, the most recent enhancement to the platform, which already incorporates FDA-cleared algorithms to detect AFib and structural heart murmurs, often indicative of valvular heart disease. Upon Low EF detection during a primary care examination with SENSORA, access to life-extending treatment can be expedited by referring patients to the cardiology department for comprehensive diagnostic testing and treatment evaluation.

"The stethoscope, an emblematic symbol of healthcare, impacts the lives of an estimated one billion people globally each year," noted Connor Landgraf, MS, co-founder & CEO of Eko Health. "With Eko’s Low EF AI, we've revolutionized the quintessential medical tool into an AI-powered heart failure early detection instrument that can help enhance access to care for millions of patients at a fraction of the time and cost of echocardiography. It has been an honor to collaborate with the Mayo Clinic on this pioneering initiative."