ENDRA’s TAEUS® Liver Device Demonstrates High-Level Consistency in Clinical Study, Delivering MRI-Level Results at the Point of Patient Care
Achieved Intraclass Correlation Coefficient (ICC) of 0.89 with standard error of measurement (SEM) of 3.3% using independent operators
The study involved 14 subjects with independent operators performing several measurements each to assess the platform's performance in real-world clinical conditions. A total of 56 unique measurements were tabulated to generate comprehensive Gage Repeatability and Reproducibility (R&R) results. This methodology quantifies how much observed measurement variability comes from the measurement system itself rather than true patient-to-patient differences, a critical factor for regulatory validation and clinical decision-making around diagnostic and treatment thresholds.
TAEUS Liver achieved an ICC of 0.89 with an SEM of 3.3%, which is considered in the "Good to Excellent" performance range. These results demonstrate the device’s high reliability regardless of the clinician performing the scan and consistent repeatability when a single user performs back-to-back measurements.
"While MRI-PDFF remains the gold standard for liver fat quantification, its high cost and limited availability create significant barriers for the more than two billion people afflicted by MASLD," stated
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