BayLabs’ Automated Ejection Fraction Software Cleared by FDA

The FDA granted 510(k) clearance to BayLabs’ EchoMD AutoEF software for fully automated AI echocardiogram analysis used in cardiovascular imaging.

The software features fully automated clip selection and calculation for left ventricular ejection fraction — a calculation widely used for measuring cardiac function such as the heart’s pumping efficiency that forms the basis for many clinical decisions.

The EchoMD AutoEF’s algorithms remove the need to manually select clips and views, automatically manipulating them for quantification.