FDA Clears AI-Powered Ejection Fraction Calculator for Clarius Ultrasound scanner App
The FDA has cleared an automated ejection fraction (EF) calculator for the Clarius wireless ultrasound scanner app, enabling real-time, AI-assisted assessment of cardiac function. The technology provides objective and rapid measurement of ejection fraction, helping primary care and emergency physicians make faster and more accurate bedside cardiac evaluations.
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.
