FDA Clears AI Ultrasound Software for Automated LVEF Calculation

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Ejection Fraction (EF) AI software, which may offer automated calculation of left ventricular ejection fraction (LVEF).

Clarius Mobile Health, the developer of Ejection Fraction (EF) AI, said the AI software tool was trained on thousands of cardiac ultrasound views and offers highly accurate EF assessments despite variations in image quality and patient body types.

The availability of Ejection Fraction AI within the Clarius app also facilitates efficiencies in the cardiac ultrasound workflow with minimal steps from the application of the ultrasound probe to immediate LVEF calculation, according to Clarius.

The company also noted the potential opportunity with Ejection Fraction AI to improve access to cardiac monitoring in rural and underserved communities where patients are often faced with prohibitive wait times for echocardiography exams.

"Quantifying cardiac function has historically required a high level of sonography expertise or a wait for formal echocardiography," noted Sarah Leverett, a vice president of marketing at Clarius. "By integrating Ejection Fraction AI into our wireless scanners, we are providing an objective anchor for clinicians. This tool allows them to move from a subjective guess to a data-driven diagnosis in seconds."