Sonic Incytes Gains FDA Clearance for Velacur ONE™, Advancing Non-Invasive Liver Disease Diagnostics
Sonic Incytes Medical Corp has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Velacur ONE™, the company’s next-generation point-of-care ultrasound elastography device. Building on the success of the original Velacur™ system, Velacur ONE™ features an upgraded interface, improved portability, and enhanced user experience—capabilities that support Sonic Incytes’ accelerated U.S. and global expansion strategy.
The new device measures attenuation, VDFF (Velacur Determined-Fat Fraction), and liver stiffness using 3D S-WAVE technology. These parameters aid in diagnosing and managing chronic liver conditions, including Metabolic dysfunction–associated steatotic liver disease (MASLD) and Metabolic dysfunction–associated steatohepatitis (MASH).
Velacur ONE™ launches at a critical time, following the FDA’s recent approval of Rezdiffra, the first therapeutic treatment for MASH—a progressive liver condition that is often underdiagnosed and can lead to cirrhosis, liver failure, cancer, or the need for transplant if untreated. In the U.S. alone, an estimated 100 million adults are affected by MASLD, with 15–20 million impacted by MASH. Alarmingly, about 90% of MASH cases remain undiagnosed.
Because current non-invasive testing methods have limitations, particularly at the point of care, clinicians face challenges in identifying and tracking disease progression. While guidelines recommend imaging-based elastography to assess fibrosis and steatosis, experts caution that liver stiffness alone is not a reliable short-term indicator of treatment response. Instead, reductions in liver fat content (steatosis)—specifically a ≥30% drop in MRI-PDFF values—are considered the best predictor of treatment success.
This is where Sonic Incytes’ proprietary VDFF algorithm, which gained FDA clearance in 2024, plays a pivotal role. VDFF shows a strong correlation (r = 0.85) with MRI-PDFF, the gold standard for measuring liver fat, and demonstrates 95% accuracy in identifying patients with more than 5% MRI-PDFF, the threshold for hepatic steatosis. By combining this validated technology with an enhanced interface, Velacur ONE™ uniquely estimates both liver stiffness and attenuation in a point-of-care setting.
The device also includes B-mode imaging and an AI-powered organ overlay tool to assist with liver localization, boosting diagnostic accuracy and enabling reimbursement levels up to three to four times higher than non-imaging elastography methods.
Barry Allen, CEO of Sonic Incytes, underscored the significance of the milestone. “The launch of Velacur ONE™ marks a pivotal milestone for Sonic Incytes as we accelerate our US and global commercial expansion strategy,” Allen said. “This next-generation device enhances clinical utility and operational scalability, positioning us to better support the growing demand for accessible, non-invasive liver diagnostics and treatment, particularly in the management of MASLD and MASH at the point-of-care.”
By expanding the availability of advanced liver diagnostics, Sonic Incytes aims to equip clinicians with practical, scalable tools to improve early detection and monitoring of MASLD and MASH—conditions expected to affect growing numbers of patients worldwide as obesity and metabolic disorders continue to rise.