FDA Clears Clarius Ejection Fraction AI for Automated Cardiac Ultrasound Assessments

Clarius Mobile Health announced FDA clearance for its Ejection Fraction AI, an intelligent cardiac assessment tool integrated directly into the Clarius ultrasound app.

Assessing left ventricular systolic function is a critical clinical decision, yet traditional methods often rely on subjective visual estimation, which is highly operator dependent. Clarius Ejection Fraction AI removes this guesswork by automatically calculating and displaying the ejection fraction percentage in real time from standard cardiac windows. The tool is available in the United States and other countries to users of Clarius PA, PAL, and C3 HD3 wireless ultrasound scanners via the latest app update.

Sarah Leverett, Vice President of Marketing at Clarius, said quantifying cardiac function has historically required a high level of sonography expertise or a wait for formal echocardiography. She noted that by integrating Ejection Fraction AI into wireless scanners, the company is providing an objective anchor for clinicians, allowing them to move from a subjective guess to a data-driven diagnosis in seconds. Dr. Brian Johnson, an emergency physician who tested the tool, said the ability to receive a calculated ejection fraction from a parasternal long or four-chamber view is magical.

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