FDA Clears Clarius Ejection Fraction AI to Deliver Objective, Real-Time Cardiac Ultrasound Assessments for Primary Care and Emergency Medicine

Integrated into the Clarius App, the new AI tool automates LVEF calculation—the key indicator of heart pumping efficiency—to remove subjectivity and accelerate diagnosis using ultrasound at the point of care.

VANCOUVER, BC, June 2, 2026 /PRNewswire/ -- Clarius Mobile Health, a leading provider of high-definition wireless ultrasound systems, today announced the availability of its new Ejection Fraction (EF) AI, which has been cleared for use by the United States Federal Department of Food and Drug Administration (FDA). This new intelligent cardiac assessment tool is integrated directly into the Clarius Ultrasound App to provide clinicians with an automated, objective measurement of left ventricular function—the percentage of blood the heart pumps out with each beat.

Assessing left ventricular (LV) systolic function is a critical clinical decision, yet traditional methods often rely on subjective visual estimation eyeballing, which is highly operator dependent. Clarius Ejection Fraction AI removes this guesswork by automatically calculating and displaying the EF percentage in real-time from standard cardiac windows. It was developed using thousands of cardiac ultrasound images annotated by clinicians to support consistent left ventricle ejection fraction assessment across a range of patient presentations.

"Quantifying cardiac function has historically required a high level of sonography expertise or a wait for formal echocardiography," says Clarius Vice President 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."

The clinical impact is evident for physicians working in high-pressure environments. "The ability to receive a calculated EF just from a parasternal long or 4 chamber view is magical," says Dr. Brian Johnson, an Emergency Physician who was one of the first to test Clarius Ejection Fraction AI.

Clarius Ejection Fraction AI is available now in the United States and other countries to users of the Clarius PA, PAL and C3 HD3 wireless ultrasound scanners via the latest app update. Access to all Clarius Intelligence tools is open to users with access to Clarius Membership and One-Time Licenses.

Key Benefits of Clarius Ejection Fraction AI:

• Removes Subjectivity: Automatically calculates and documents ejection fraction percentage based on cardiac ultrasound images without requiring user intervention.
  
  
• Accelerates Diagnosis: Provides high-accuracy EF results across a range of patient body types and image qualities.
  
  
• Seamless Workflow: Integrates directly into the Clarius App, requiring minimal steps from probe-on-patient to result.
  
  
• Improves Access: Enables cardiac monitoring in rural or underserved communities where formal echocardiography wait times are often prohibitive.

Bridging the Gap in Primary Care

The American Academy of Family Physicians (AAFP) recently recognized cardiac POCUS as a core clinical competency. However, many primary care physicians lack the specialized training to accurately interpret LV function. Ejection Fraction AI provides these clinicians with a longitudinal marker of disease progression.

By identifying a decline in EF before a patient reaches a crisis point, such as a drop below 40%, indicating possible heart failure, physicians can trigger guideline-directed medical therapy and informed specialist referrals earlier.

Speed and Precision for Emergency Medicine

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 that fluid resuscitation and medication initiation are based on precise, real-time cardiac data.

About Clarius Mobile Health

Clarius is on a mission to make accurate, easy-to-use, and affordable ultrasound tools available to all medical professionals in every specialty. With decades of experience in medical imaging, the team knows that great ultrasound imaging improves confidence and patient care. Today, AI-powered Clarius handheld wireless ultrasound scanners connect to iOS and Android devices, delivering high-resolution ultrasound images traditionally only available with bulkier, high-end systems at a fraction of the cost. Almost 7 million high-definition scans have been performed using Clarius wireless handheld scanners. Clarius scanners are available in over 70 countries worldwide. Learn more at www.clarius.com.

Media Contact:

Sarah Leverett

1.206.550.6120

[email protected]

SOURCE Clarius Mobile Health