Clarius Mobile Health has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Ejection Fraction AI, a semiautomated left ventricular ejection fraction (LVEF) measurement tool integrated into the Clarius Ultrasound App.
The assistive tool automatically calculates and displays LVEF percentage in real time from standard cardiac windows, according to the company. It was developed using thousands of cardiac ultrasound images annotated by clinicians, the company said.
Ejection Fraction AI is available in the U.S. and other countries to users of the Clarius PA, PAL, and C3 HD3 wireless ultrasound scanners, the company noted.
