CAUTION – LiverScope® is an investigational device. Limited by Federal (or United States) law to investigational use
LiverScope® is offering a game-changing solution to the challenges faced by conventional liver disease diagnostic methods. Experience the power of cutting-edge technology, combined with patient comfort and accuracy – with LiverScope®.
Livivos addresses the urgent need to diagnose liver disease with the high accuracy of MRI but in a point-of-care setting. Biopsies are invasive and expensive, Ultrasound-based methods are intrinsically limited in fat measurement accuracy, and MRI, although non-invasive and accurate, requires highly trained operators and is not broadly available.
Scheduling and patient comfort advantages open the possibility for frequent and accurate liver disease diagnosis. LiverScope® supports preventive medicine, effective disease progression monitoring, and accurate clinical treatment management.
QUANTIFICATION of liver fat is key for assessing liver health as many treatments are directed at reducing liver fat (anti-steatotic). Measuring fat accurately helps determine the treatment’s mechanism and efficacy.
LiverScope® reads the Proton Density Fat Fraction (PDFF), a measure of liver fat which was developed for clinical MRI. The diagnosis is completed without the need for a radiologist.
The LiverScope® performance was quantified using a series of certified phantom samples from Calimetrix. Calimetrix provides advanced quantitative MRI PDFF reference specimens for clinical and research measurements.
LiverScope® PDFF values show a high linear correlation to certified MRI PDFF values, with an R-squared > 0.99. The quantitative method provides a reliable means for steatosis grading.
Clinical Study at University of California, San Diego
LiverScope®‘s performance was evaluated with an in-vivo clinical study with volunteers at UC San Diego. For each participant, the Livivos’s PDFF results were compared to the PDFF attained by an FDA-cleared MRI method (GE IDEAL IQ).
LiverScope® liver fat measurements show remarkable equivalence to MRI PDFF
Linear Correlation R-squared > 0.94
Comparative Measurements of MRI Proton Liver Density Fat Fraction (PDFF) and LiverScope® PDFF.
Eduardo Grunvald, M.D. Medical Director, UC San Diego Weight Management Program. Clinical Professor of Medicine.
UC San Diego Bariatric and Metabolic Institute. 4520 Executive Drive, Suite 111. San Diego, CA 92121.
UC San Diego Center for Translational Imaging and Precision Medicine (CTIPM), Altman Clinical and Translational Research Institute (ACTRI).