FDA Clears Clarius Ejection Fraction AI for Cardiac Ultrasound Assessment

Clarius Mobile Health announced that its new Ejection Fraction AI has been cleared for use by the U.S. Food and Drug Administration (FDA), according to a press release. The tool is integrated into the Clarius App and provides automated, objective measurements of left ventricular ejection fraction, a key indicator of heart function.

The software analyzes standard cardiac ultrasound images to calculate and display ejection fraction percentages in real time. It was developed using thousands of annotated cardiac images to ensure consistency across various patient types. The tool aims to remove subjectivity from traditional visual assessments, offering data-based results within seconds.

Ejection Fraction AI can assist primary care and emergency physicians by accelerating cardiac evaluations. In emergency settings, it can deliver actionable data within 90 seconds, supporting treatment decisions for conditions such as shock or trauma. The system is available in the United States and other regions for users of the Clarius PA, PAL, and C3 HD3 scanners through the latest app update.

The feature is accessible to clinicians through Clarius Membership or one-time licenses and is designed to expand access to cardiac monitoring, particularly in areas with limited echocardiography services.