FDA OKs Sonic Incytes’ Velacur Determined Fat Fraction

Sonic Incytes Medical Corp., a company focused on point-of-care (POC) ultrasound, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Velacur determined fat fraction (VDFF).
 
The tool, which is integrated into the company’s Velacur device software, combines quantitative measures of ultrasound attenuation and backscatter. It has a correlation coefficient of 0.85, estimating MRI proton density fat fraction (MRI-PDFF), which is the hospital-based gold standard in liver fat measurement.
 
The company said VDFF provides similar clinical utility to MRI-PDFF at the POC, transforming management of hepatic steatosis.
 
Sonic Incytes said its VDFF comes at a critical time because it follows the recent FDA clearance of the first metabolic dysfunction associated steatohepatitis (MASH) therapeutic. In addition, the company said recently published clinical guidance by the AASLD recommends liver ultrasound as a secondary screen to blood tests.
 
“The approval of Rezdiffra (Madrigal Pharmaceuticals) was a big win for patients, but it also highlighted the urgent need for reliable non-invasive tests (NITs). VDFF is a promising new tool that will arm providers with the data we need to manage and monitor patients at the point of care,” said Dr. Naim Alkhouri, chief medical officer, Chief of Transplant Hepatology, and Director of the Steatotic Liver Program at Arizona Liver Health (ALH) in Phoenix, Ariz.
 
Sonic Incytes said it expects to release the VDFF feature to new and existing Velacur users in the U.S. via a software update in the upcoming weeks.