FDA Grants 510(k) Clearance for Sonic Incytes’ Velacur ONE™, AI-guided point of care ultrasound for the management of chronic liver diseases
VANCOUVER, British Columbia–(BUSINESS WIRE)–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.
