French ultrasound developer E-Scopics has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for technology that quantifies liver fat using its hepatoscope device.
Called the Hepatoscope-Derived Fat Fraction, the technology combines two quantitative ultrasound parameters already available on the point-of-care Hepatoscope system, attenuation and backscattering coefficient, to generate an intrahepatic fat fraction estimate. The technology demonstrated a 0.93 correlation coefficient with MRI-based proton density fat fraction as a reference standard and a 0.93 area under the receiver operating characteristic curve (AUROC) for detection of liver steatosis, according to the company.
The clearance expands the Hepatoscope platform's capabilities for use in primary care, hepatology, endocrinology, and obesity medicine settings, E-Scopics said.
