FDA Clears Sonic Incytes’ Velacur ONE™, AI-Powered Point-of-Care Ultrasound for Chronic Liver Disease Management

VANCOUVER, British Columbia — Sonic Incytes Medical Corp. announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Velacur ONE™, its next-generation, AI-guided point-of-care ultrasound elastography device designed for the management of chronic liver diseases. Building on the success of its original Velacur™ platform, Velacur ONE™ features an upgraded interface, enhanced portability, and improved user experience, enabling greater accessibility and scalability across clinical settings. The device leverages artificial intelligence to deliver real-time, accurate liver stiffness measurements—key indicators in assessing liver fibrosis and cirrhosis—without the need for specialized training or large imaging equipment. This advancement supports early detection and ongoing monitoring of chronic liver conditions, particularly in primary care and outpatient environments where access to traditional liver imaging may be limited. Sonic Incytes highlighted that Velacur ONE™ is designed to integrate seamlessly into routine clinical workflows, empowering healthcare providers to make timely decisions at the point of care. The device’s compact, lightweight design and intuitive interface make it ideal for use in diverse settings, including community clinics, mobile health units, and remote areas. With the FDA clearance, Sonic Incytes is poised to expand its presence in the U.S. market and accelerate global distribution. The company is focused on increasing adoption among primary care physicians, hepatologists, and gastroenterologists, aiming to improve outcomes for patients with conditions such as non-alcoholic fatty liver disease (NAFLD), hepatitis B and C, and other chronic liver disorders. The company emphasized that Velacur ONE™ maintains the high diagnostic accuracy of its predecessor while offering faster scan times, improved image quality, and enhanced data management tools. These features support more consistent and reliable results, reducing variability and improving patient care. Sonic Incytes continues to invest in AI-driven innovation to address unmet needs in liver disease diagnostics. The clearance of Velacur ONE™ marks a significant milestone in the company’s mission to democratize access to advanced liver health assessment technologies.