Sonic Incytes Medical has announced receipt of 510(k) clearance from the US Food and Drug Administration (FDA) for its Velacur Determined Fat Fraction (VDFF).
This new tool is integrated into the Velacur device software and is designed to transform the management of hepatic steatosis, also known as fatty liver disease, by providing similar clinical utility to MRI proton density fat fraction (MRI-PDFF) at the point of care.
The VDFF combines quantitative measures of ultrasound attenuation and backscatter, boasting a strong correlation coefficient of 0.85 with MRI-PDFF, the hospital-based gold standard for liver fat measurement. With a 95% accuracy as a classifier of patients with more than 5% MRI-PDFF, VDFF is claimed to be a significant advancement in the diagnosis of hepatic steatosis.
In the US, metabolic dysfunction-associated steatotic liver disease (MASLD) impacts nearly 100 million individuals, with approximately 20% progressing to metabolic dysfunction-associated steatohepatitis (MASH), a chronic disease that can lead to cancer and death.
Existing non-invasive methods for diagnosing MASH and MASLD, particularly those available at the point of care, have limitations, making VDFF's arrival particularly timely following the FDA clearance of the first MASH therapeutic.
Arizona Liver Health Steatotic Liver Program director, chief medical officer, and chief of transplant hepatology Dr 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.
The Velacur device is Sonic Incytes' flagship product and equips physicians with an advanced liver imaging tool to help manage the growing epidemic of fatty liver disease.
It offers real-time, AI-guided quantification of key markers for fatty liver disease: liver stiffness, attenuation, and VDFF, making liver imaging at the point of care both affordable and accessible.
In January of the previous year, Sonic Incytes Medical's project was selected for investment by the inaugural INOVAIT Focus Fund, a pan-Canadian network funded by the Government of Canada, which strategically invests in projects at the intersection of advanced imaging, minimally invasive therapies, and AI.
