Sonic Incytes' Velacur VDFF Receives FDA 510(k) Clearance for Enhanced Liver Fat Assessment
Key Insights
Sonic Incytes (search)' Velacur (search) Determined Fat Fraction (VDFF) receives FDA 510(k) clearance, integrating quantitative ultrasound measures for liver fat assessment.
VDFF demonstrates a strong correlation (0.85) with MRI-PDFF, the gold standard, and 95% accuracy in classifying hepatic steatosis (search).
The new tool offers similar clinical utility to MRI-PDFF at the point of care, which transforms the management of hepatic steatosis (search) (fatty liver disease).
Sonic Incytes (search) Medical Corp has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Velacur (search)® Determined Fat Fraction (VDFF). This innovative tool, integrated into the Velacur® device software, combines quantitative measures of ultrasound attenuation and backscatter to provide clinicians with an accurate assessment of liver fat at the point of care.
VDFF: A Non-Invasive Solution for Liver Fat Quantification
The Velacur (search)® VDFF estimates MRI proton density fat fraction (MRI-PDFF) with a strong correlation coefficient of 0.85. MRI-PDFF is considered the hospital-based gold standard for liver fat measurement. VDFF demonstrates an outstanding accuracy (AUC) of 95% as a classifier of patients with more than 5% MRI-PDFF, which is a key threshold for defining hepatic steatosis (search).
Addressing the Growing Burden of MASLD and MASH
Metabolic dysfunction-associated steatotic liver disease (search) (MASLD (search)) affects nearly 100 million people in the US, with approximately 20% progressing to metabolic dysfunction-associated steatohepatitis (search) (MASH (search)), a severe chronic condition that can lead to cancer and death. The limitations of existing non-invasive diagnostic methods, particularly those available at the point of care, have made effective diagnosis challenging.
Expert Commentary
Dr. Naim Alkhouri, Chief Medical Officer, Chief of Transplant Hepatology, and Director of the Steatotic Liver Program at Arizona Liver Health (ALH), stated, “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.”
Clinical Implementation
Sonic Incytes (search) plans to release the VDFF feature to all new and existing Velacur (search)® users in the United States through a software update in the coming weeks. This update will provide clinicians with real-time, AI-guided quantification of key markers for fatty liver disease, including liver stiffness, attenuation, and VDFF.
About Velacur
Velacur (search) is Sonic Incytes (search)' flagship product, designed to provide physicians with an advanced liver imaging tool for managing fatty liver disease. The device offers real-time results, a low up-front cost, and AI guidance, making liver imaging at the point of care more affordable and accessible. The VDFF measurement is supported by clinical research published in the World Federation for Ultrasound in Medicine and Biology.