Eko wins FDA nod for AI to detect signs of heart failure using stethoscope

Eko Health received 510(k) clearance for a stethoscope feature detecting a heart failure indicator during routine exams. In primary care, echocardiography and other traditional detection tools are often inaccessible due to cost, training requirements, and time constraints. Incorporating low EF (ejection fraction) detection into digital stethoscopes could overcome these barriers, diagnosing more patients before severe symptoms develop.

Developed with Mayo Clinic, Eko's AI tool received FDA breakthrough designation in 2019, with a study of over 50,000 patients demonstrating 86% sensitivity, specificity, and accuracy. The FDA cleared Eko algorithms for atrial fibrillation and heart murmurs in 2020.

In 2023, Eko introduced its Sensora platform and discussed two new machine-learning algorithms: one for low EF and another for detecting and classifying pulmonary hypertension. Eko received a $2.7 million grant for pulmonary hypertension research in 2022.

This low EF clearance marks another FDA authorization for AI-powered devices this year, including software for lung conditions, dementia risk assessment, and skin and cervical cancer screening.