Sonic Incytes Medical Corp has secured FDA 510(k) clearance for Velacur ONE™, an AI-guided point-of-care ultrasound elastography device aimed at diagnosing and monitoring chronic liver diseases like MASLD and MASH. Building on its predecessor, Velacur™, the new model offers improved portability, a refined interface, and advanced features such as B-mode imaging and AI-based organ overlay for precise liver localization.
The device measures attenuation, VDFF (Velacur Determined-Fat Fraction), and liver stiffness, combining these metrics to aid in early detection and treatment monitoring. VDFF technology, cleared in 2024, shows strong correlation with MRI-PDFF—the gold standard for liver fat measurement—and enables higher reimbursement potential compared to non-imaging elastography.