E-Scopics has received FDA 510(k) clearance for Hepatoscope-Derived Fat Fraction, a quantitative ultrasound feature for estimating liver fat on its Hepatoscope system.
The technology combines 2 ultrasound parameters already available on the device: ultrasound attenuation and backscattering coefficient. E-Scopics said the output is an intrahepatic fat-fraction estimate.
Company-reported validation showed a 0.93 correlation coefficient with MRI proton density fat fraction as the reference standard. E-Scopics also reported a 0.93 AUROC for detecting liver steatosis, defined as MRI-PDFF above 5%.
The feature expands the Hepatoscope platform, a point-of-care ultrasound system used for noninvasive liver assessment. The company said the technology is intended for use in primary care, hepatology, endocrinology, obesity medicine, and other settings involved in metabolic liver disease management.
FDA records for the ES-Series list the device as a class II ultrasonic pulsed Doppler imaging system. The indication includes abdominal imaging and measurements of physical properties in the liver and spleen.
Those FDA records also state that the system can provide ultrasound tissue brightness parameters in the liver, including attenuation and backscattering coefficient, and that these measurements may aid diagnosis, monitoring, and clinical management of adult and pediatric patients with liver disease.
E-Scopics said the HDFF feature is designed to integrate into existing Hepatoscope examinations without requiring a separate imaging appointment.
Company:E-Scopics
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