Diagnostic solutions provider Sonic Incytes has received the US Food and Drug Administration (FDA) 510(k) clearance for its Velacur Determined Fat Fraction (VDFF) tool.
VDFF is designed for patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH).
The advanced tool, integrated into the Velacur device software, combines ultrasound attenuation and backscatter measurements to provide accurate fat fraction estimates.
Velacur is Sonic Incytes’ flagship product, designed to provide physicians with an advanced liver imaging tool to better manage fatty liver disease. The device provides real-time, artificial intelligence (AI)-guided quantification of crucial markers for fatty liver disease.
According to Sonic Incytes, the product is intended to make liver imaging both affordable and accessible at the point of care. It is also said to offer immediate results, a low initial cost, and advanced AI support.
VDFF estimates MRI proton density fat fraction (MRI-PDFF), the established standard for liver fat assessment, with a correlation coefficient of 0.85.
The diagnostic tool demonstrated accuracy, with an AUC of 95% in classifying patients with more than 5% MRI-PDFF, which indicates the presence of hepatic steatosis.
In March, the FDA cleared Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring.
Arizona Liver Health steatotic liver programme director, chief medical officer, and transplant hepatology chief Naim Alkhouri said: “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.”
Sonic Incytes plans to roll out the VDFF feature to all new and existing Velacur users in the US through a software update in the coming weeks.
In May last year, the diagnostic solutions provider secured FDA’s additional clearance for new Organ Guide and Wave Quality Detector features for Velacur.
These AI and machine learning-based tools are designed to enhance the accuracy and performance of the device.
