Clarius Ejection Fraction AI gains FDA clearance
The software is integrated into the Clarius Ultrasound App and is intended for semi-automatic LVEF measurement in adult patients using compatible Clarius scanners.
Clarius Ejection Fraction AI can now be marketed in the U.S. for semi-automatic measurement of left ventricular ejection fraction on ultrasound data acquired with Clarius scanners, according to FDA 510(k) records. The FDA listed the device as substantially equivalent on March 2, 2026, under product code QIH for automated radiological image processing software.
The software is integrated into the Clarius Ultrasound App and is not a stand-alone device. FDA records state that it is intended for trained and qualified ultrasound users and for adult patients only.
The tool uses a deep learning image segmentation algorithm to identify the left ventricle and calculate ejection fraction from cardiac ultrasound images. It can use parasternal long-axis, parasternal short-axis, apical 4-chamber, and apical 2-chamber views, according to the FDA summary.
Users can manually adjust the measurements by moving caliper crosshairs. The FDA summary states that the tool is assistive and does not replace clinical decision-making.
Clinical verification used 279 de-identified cardiac ultrasound exams from an anonymized multi-center database. The dataset was independent of the training, tuning, and internal testing datasets, according to the FDA summary.
The primary objective was to test whether the AI measurements were non-inferior to manual measurements by human experts or qualified ultrasound users. The automatic LV EF measurement was found to be non-inferior across apical, PSAX, and PLAX views, with statistically significant p-values reported for each view.
The FDA summary reported an intraclass correlation coefficient of 0.78 for AI EF versus mean reviewer measurements. Reviewer-to-reviewer ICC values ranged from 0.54 to 0.67.
Clarius said the tool is available in the U.S. and other countries for users of its PA HD3, PAL HD3, and C3 HD3 wireless ultrasound scanners through the latest app update. Access is available through Clarius Membership and One-Time Licenses, according to the company announcement.
Companies:Clarius Mobile Health, U.S. Food and Drug Administration
U.S. Food and Drug Administration coverage
Sources
- K253593 - Clarius Ejection Fraction AI. Regulatory filing
- 510(k) Summary K253593. Regulatory filing
About the author
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Radiology Signal Staff covers developments across medical imaging, radiology AI, imaging informatics, clinical research, and radiology business. The team monitors primary sources, peer-reviewed studies, company announcements, society updates, and healthcare industry news to deliver concise reporting for imaging professionals.
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