FDA Grants 510(k) Clearance for Sonic Incytes’ Velacur ONE™, AI-Guided Point of Care Ultrasound for the Management of Chronic Liver Diseases
Sonic Incytes Medical Corp, proudly announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Velacur ONE™, its point-of-care ultrasound elastography device. Building on the success of its original model, Velacur™, Velacur ONE™ introduces an enhanced interface and features for improved portability and user experience. These improvements enable broader scalability to support Sonic Incytes’ accelerated US and global expansion strategy. Velacur ONE™ measures attenuation, VDFF (Velacur Determined-Fat Fraction), and liver stiffness using 3D S-WAVE and aids in the management of chronic liver disease including MASH and MASLD.
FDA Grants 510(k) Clearance to Sonic Incytes' Velacur® Determined Fat Fraction (VDFF), a breakthrough for patients with MASLD and MASH
Sonic Incytes Medical Corp, a leader in point-of-care ultrasound, proudly announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Velacur® Determined Fat Fraction (VDFF). This innovative measurement tool is integrated into the Velacur® device software, combining quantitative measures of ultrasound attenuation and backscatter. With a strong correlation coefficient of 0.85, VDFF estimates MRI proton density fat fraction (MRI-PDFF)1, the hospital-based gold standard in liver fat measurement. VDFF has an outstanding accuracy (AUC) of 95% as a classifier of patients with more than 5% MRI-PDFF1,2, a definition for the presence of hepatic steatosis.
