Clarius Ejection Fraction AI
Overview
Clarius Ejection Fraction AI is an intelligent, real-time cardiac assessment tool integrated directly into the Clarius Ultrasound App. It automates the calculation of left ventricular ejection fraction (LVEF), a key indicator of heart pumping efficiency, to remove subjectivity and accelerate diagnosis using ultrasound at the point of care. The tool was developed using thousands of cardiac ultrasound images annotated by clinicians to support consistent LVEF assessment across a range of patient presentations and image qualities. It is designed to provide objective, data-driven diagnoses in seconds, addressing the historical reliance on subjective visual estimation or the need for specialized sonography expertise and formal echocardiography.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Automated LVEF calculation
- Real-time display of EF percentage
- Removes subjectivity in cardiac assessment
- Accelerates diagnosis
- Seamless integration into Clarius App
- Works across multiple cardiac views
- High accuracy across various patient body types and image qualities
- Supports consistent LVEF assessment
- AI-guided training mode (T-Modeu2122 Heart) for anatomy recognition
- PDF reports with key cardiac values
Use Cases
- Real-time cardiac assessments at the point of care
- Evaluating undifferentiated shortness of breath
- Assessing septic shock
- Trauma evaluation
- Cardiac monitoring in rural or underserved communities
- Early detection of heart failure and guiding medical therapy
What Physicians Need to Know
Clarius Ejection Fraction AI offers an objective and rapid assessment of left ventricular function, which is particularly beneficial in high-pressure environments like emergency and critical care settings where timely data is crucial for guiding resuscitation and treatment. For primary care physicians, who may lack specialized training in interpreting LV function, this AI tool provides a valuable, objective marker for disease progression, enabling earlier intervention and specialist referrals when a decline in EF is detected. The ability to calculate EF across multiple cardiac views adds flexibility and practicality in real-world scanning scenarios.
Clarius Ejection Fraction AI is integrated directly into the Clarius Ultrasound App and is accessible to users of Clarius PA, PAL, and C3 HD3 wireless ultrasound scanners through a software update. Access to this and other Clarius Intelligence tools is available to users with a Clarius Membership or One-Time Licenses.
Details
| Category | Cardiology AI |
| Pricing | Contact for pricing — Access available with Clarius Membership or One-Time Licenses |
| Deployment | Mobile App (integrated with Clarius Ultrasound App) |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Cleared AI-estimated Clarius Ejection Fraction AI received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on June 2, 2026. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Critical Care, Radiology |
What the Web Says
Clarius Ejection Fraction AI is an FDA-cleared software integrated into Clarius wireless ultrasound scanners that provides automated, real-time calculation of left ventricular ejection fraction (LVEF). This AI tool aims to reduce the subjectivity and high level of sonography expertise traditionally required for cardiac function assessment, making it more accessible for clinicians in various settings, including emergency and critical care, and potentially improving access to cardiac monitoring in underserved communities.
Overall: PositiveStrengths
- Automated and objective LVEF calculation, reducing operator dependence and variability.
- Real-time results, providing actionable information quickly, especially crucial in emergency settings.
- Works across multiple cardiac views, offering flexibility in real-world scanning.
- Trained on thousands of cardiac ultrasound images, leading to accurate assessments despite variations in image quality and patient body types.
- Improves access to cardiac monitoring in rural and underserved communities.
- User-friendly and easy-to-use software with good quality images.
Limitations
- Pricing information was not fully verified.
- Detailed source review for privacy, security, and compliance pages is still needed.
- Implementation fit depends on local workflow, integrations, and contract terms.
- Some users of Clarius devices (which host the AI) have reported issues with poor wireless connection and slow frame rates, particularly with Android devices.
- Initial connection time can be a pain point for the wireless Clarius devices.
Based on reviews from: Clarius PAL HD3 Review: The AI Handheld Ultrasound That Teaches You While You Scan, Clarius Ejection Fraction AI Review & Alternatives - HealthAIdir, FDA Clears AI Ultrasound Software for Automated LVEF Calculation | Diagnostic Imaging, FDA OKs Clarius' Ejection Fraction AI for Cardiac Ultrasound - Medical Product Outsourcing, FDA Clears Clarius Ejection Fraction AI to Deliver Objective, Real-Time Cardiac Ultrasound Assessments - Diagnostic and Interventional Cardiology, FDA Clears Clarius Ejection Fraction AI to Deliver Objective, Real-Time Cardiac Ultrasound Assessments for Primary Care and Emergency Medicine - PR Newswire, Clinical Validation of an Artificial Intelligenceu2013Based Tool for Automatic Estimation of Left Ventricular Ejection Fraction and Strain in Echocardiography: Protocol for a Two-Phase Prospective Cohort Study - PMC, Clarius : r/pocus - Reddit, Handheld US: Butterfly vs Clarius? : r/medicine - Reddit, Harnessing the Power of AI: A Comprehensive Review of Left Ventricular Ejection Fraction Assessment With Echocardiography - PubMed, What Three ER Physicians Say About the New Clarius PAL Dual-Array Ultrasound Scanner, Artificial Intelligence-Assisted Point-of-Care Ultrasound for Evaluating Left Ventricular Ejection Fraction: A Systematic Review of Prospective Observational Studies - PubMed, Clarius Ultrasound App - Ratings & Reviews, Best handheld ultrasound machine in the market now? : r/emergencymedicine - Reddit, AI-Assisted LVEF Assessment Using a Handheld Ultrasound Device: A Single-Center Comparative Study Against Cardiac Magnetic Resonance Imaging - PMC, Artificial Intelligence in Cardiac Point-of-Care Ultrasound: A Narrative Review - PubMed
Last updated: 2026-08-19
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Clarius Feature: Ejection Fraction
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