Clarius Launches FDA-Cleared Ejection Fraction AI for Wireless Ultrasound

Clarius Mobile Health on June 2 made its Ejection Fraction AI available to North American users of its wireless handheld ultrasound scanners, adding software that automatically calculates how much blood the heart's left ventricle pumps out with each beat. The Vancouver company said in its announcement that the tool has been cleared by the U.S. Food and Drug Administration.

The clearance itself came earlier. The FDA's 510(k) database lists Clarius Ejection Fraction AI under number K253593, received on November 17, 2025, with a decision date of March 2, 2026, and a finding of substantial equivalence to a device already on the market. The agency classifies it as automated radiological image processing software, product code QIH.

What the software does

Left ventricular ejection fraction, or LVEF, is a standard measure of how well the heart pumps. Clarius said clinicians often estimate it by eye on ultrasound, a method it described as highly operator dependent. The new tool runs inside the Clarius Ultrasound App and calculates and displays the ejection fraction percentage in real time from standard cardiac views, according to the company.

Clarius said the software was developed using thousands of cardiac ultrasound images annotated by clinicians. The company said it provides high-accuracy results across a range of patient body types and image qualities; the announcement does not include study data, and the FDA database entry does not report performance results. Diagnostic Imaging likewise attributed the accuracy description to the company.

"Quantifying cardiac function has historically required a high level of sonography expertise or a wait for formal echocardiography," said Sarah Leverett, Clarius vice president of marketing. "By integrating Ejection Fraction AI into our wireless scanners, we are providing an objective anchor for clinicians."

Who it is aimed at

The company is pitching the tool at clinicians who use point-of-care ultrasound without specialist echocardiography training. It noted that the American Academy of Family Physicians has recognized cardiac point-of-care ultrasound as a core clinical competency, and said many primary care physicians lack the training to interpret left ventricular function accurately.

For emergency and critical care, Clarius said the software delivers results within the 90-second window it described as required for resuscitation guidance, and can help in evaluating undifferentiated shortness of breath, septic shock and trauma. The company also said the tool could extend cardiac assessment to rural and underserved areas where waits for formal echocardiography are long.

Ejection Fraction AI is available through the latest app update for the Clarius PA, PAL and C3 HD3 scanners, and access to the company's AI tools is open to users with a Clarius Membership or one-time license, the company said. Clarius did not disclose pricing for the feature. The company said almost 7 million scans have been performed with its handheld scanners, which are sold in more than 70 countries.