Canada-based Sonic Incytes has received the US Food and Drug Administration (FDA) 510(k) clearance for Velacur ONE to help manage chronic liver diseases.
The point-of-care ultrasound elastography device builds on the company’s previous Velacur model, offering enhanced portability and a user interface.
Velacur ONE employs 3D S-WAVE technology to measure liver stiffness, attenuation, and VDFF (Velacur Determined-Fat Fraction).
It supports the management of MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) and MASH (Metabolic Dysfunction-Associated Steatohepatitis).
Sonic Incytes CEO Barry Allen said: “The launch of Velacur ONE marks a pivotal milestone for Sonic Incytes as we accelerate our US and global commercial expansion strategy.
“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.”
The FDA clearance follows the approval of Rezdiffra, the first therapeutic for Metabolic dysfunction-associated steatohepatitis (MASH).
MASH, a serious liver condition, often goes undiagnosed due to limitations in current non-invasive methods.
Velacur ONE addresses the shortcomings by providing real-time, AI-guided imaging to assess liver scarring and fat content, essential for monitoring treatment response.
Its VDFF algorithm, approved by the FDA last year, shows strong correlation with MRI-PDFF, the gold standard for liver fat measurement.
The technology, combined with a refined user interface and AI-based organ overlay, positions Velacur ONE as a complete tool for liver assessment at the point of care.
