Eko Earns FDA Clearance for Atrial Fibrillation, Heart Murmur Algorithms
The FDA granted 510(k) clearance to Eko’s atrial fibrillation and heart murmur algorithms for use with its digital stethoscopes.
Equipped with the algorithms, the stethoscopes can screen and detect heart conditions in patients during routine physicals.
Eko said it plans to seek FDA approval for additional cardiac screening algorithms for use with its digital stethoscopes. In December, the agency gave breakthrough status designation to the company’s novel ECG-based algorithm designed for heart failure screening.