VANCOUVER, British Columbia, June 2, 2026
Clarius Mobile Health has achieved a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) clearance of Clarius Ejection Fraction (EF) AI, an advanced artificial intelligence-powered cardiac assessment tool designed to automate the measurement of left ventricular ejection fraction (LVEF) during point-of-care ultrasound examinations. Integrated directly into the Clarius Ultrasound App, the innovative technology enables clinicians to obtain real-time, objective assessments of cardiac pumping efficiency, helping eliminate subjectivity and accelerate diagnosis in primary care, emergency medicine, and critical care settings. The FDA-cleared solution represents a major advancement in the use of artificial intelligence within handheld ultrasound systems and underscores the growing role of intelligent diagnostic tools in improving cardiovascular care. By transforming a traditionally expertise-dependent evaluation into an automated workflow, Clarius aims to make advanced cardiac assessment more accessible across a broad range of healthcare environments.
AI-Powered Cardiac Assessment Eliminates Subjective Interpretation
Left ventricular ejection fraction is one of the most important indicators of heart function and is routinely used to diagnose and monitor conditions such as heart failure, cardiomyopathy, septic shock, and other cardiovascular disorders. Traditionally, evaluating cardiac function often relies on visual estimation by experienced sonographers or requires referral for formal echocardiography, introducing variability and potential delays in clinical decision-making. Clarius EF AI automatically calculates and displays ejection fraction percentages in real time from standard cardiac ultrasound views, providing clinicians with objective data within seconds. Developed using thousands of clinician-annotated cardiac ultrasound images, the AI algorithm was trained to support accurate and consistent assessments across a diverse range of patient body types and imaging conditions.
By reducing operator dependence and removing guesswork from cardiac ultrasound interpretation, the technology has the potential to improve diagnostic confidence while supporting more standardized patient care. The integration of EF AI directly into the Clarius Ultrasound App further streamlines workflow, enabling healthcare providers to move from image acquisition to actionable clinical information without additional software or complex post-processing steps.
Expanding Access to Advanced Cardiac Imaging in Primary Care
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The FDA clearance arrives at a time when point-of-care ultrasound (POCUS) is rapidly gaining adoption across healthcare specialties. Recent recognition of cardiac POCUS as a core competency by the American Academy of Family Physicians has increased interest in technologies capable of simplifying cardiac assessments for frontline clinicians. Many primary care physicians, however, may not possess advanced echocardiography expertise, creating barriers to widespread implementation. Clarius EF AI addresses this challenge by providing a reliable longitudinal marker of cardiac function that can help identify declining ejection fraction before patients experience severe symptoms.
Early detection of reductions in EF, particularly values below 40% associated with heart failure, may enable physicians to initiate guideline-directed therapies and specialist referrals sooner. For rural and underserved communities where access to formal echocardiography services may be limited or delayed, the technology offers a practical solution capable of expanding access to timely cardiovascular evaluation and improving patient outcomes.
Delivering Real-Time Decision Support in Emergency Medicine
Emergency physicians and critical care specialists often operate in environments where rapid decision-making can significantly impact patient survival. Clarius EF AI is designed to provide actionable cardiac information within the critical diagnostic window required for emergency interventions. The tool can support evaluation of undifferentiated shortness of breath, trauma, septic shock, fluid responsiveness, and acute cardiac dysfunction, enabling clinicians to make informed treatment decisions based on objective cardiac performance data. Compatible with the Clarius PA, PAL, and C3 HD3 wireless ultrasound scanners, the FDA-cleared solution is immediately available across North America through the latest Clarius app update.
As healthcare systems increasingly embrace artificial intelligence to enhance clinical workflows, Clarius EF AI represents a significant step forward in democratizing advanced cardiac ultrasound, improving diagnostic precision, and bringing real-time cardiovascular intelligence directly to the bedside. The clearance further strengthens Clarius’ position as a leader in handheld ultrasound innovation and highlights the expanding impact of AI-driven medical imaging technologies in modern healthcare.
Source: Clarius press release
