FDA OKs Clarius’ Ejection Fraction AI for Cardiac Ultrasound

Clarius Mobile Health, a provider of high-definition wireless ultrasound systems, has earned U.S. Food and Drug Administration (FDA) clearance for its new Ejection Fraction (EF) AI. The intelligent cardiac assessment tool integrates into the Clarius Ultrasound App to provide an automated, objective measurement of left ventricular function—the percentage of blood the heart pumps out with each beat.

Traditional methods to assess left ventricular (LV) systolic function rely on subjective visual estimation eyeballing, which highly depends on the operator. Clarius Ejection Fraction AI automatically calculates and displays the EF percentage in real-time from standard cardiac windows. It was built using thousands of cardiac ultrasound images annotated by clinicians to support consistent LV EF evaluation for a variety of patient presentations.

Ejection Fraction AI is now available in the U.S. and other countries to users of the Clarius PA, PAL, and CD3 HD3 wireless ultrasound scanners via the latest app update. The tool can allow cardiac monitoring in rural or underserved communities where formal echocardiography wait times are often prohibitive.

In emergency and critical care settings, where time is the most critical variable, Ejection Fraction AI delivers actionable information within the 90-second window required for resuscitation guidance. The ultrasound tool assists in evaluating undifferentiated shortness of breath, septic shock, and trauma, ensuring fluid resuscitation and medication initiation are based on precise, real-time cardiac data.

“Quantifying cardiac function has historically required a high level of sonography expertise or a wait for formal echocardiography,” said Clarius VP of marketing Sarah Leverett. “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.”