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FDA Grants 510(k) Clearance for Sonic Incytes’ Velacur ONE™, AI-Guided Point of Care Ultrasound for the Management of Chronic Liver Diseases

via 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.

Velacur ONE™ arrives at a critical time for improved non-invasive testing, following the recent FDA clearance of Rezdiffra—the first therapeutic for Metabolic dysfunction–associated steatohepatitis (MASH), a progressive and often underdiagnosed liver disease. In the U.S. alone, an estimated 100 million adults have Metabolic dysfunction–associated Steatotic Liver Disease (MASLD)1, with 15–20 million of those affected by MASH2. Yet, 90% of MASH cases remain undiagnosed3. If left untreated, worsening MASH increases morbidity and may progress to severe complications, including cirrhosis, liver failure, liver cancer, and liver transplant4,5. MASH remains challenging to diagnose effectively due to the limitations of existing non-invasive methods, especially those available at the point-of-care.

With the first therapeutic now available and more in the pipeline, clinicians need improved non-invasive tests to diagnose and monitor MASH at point-of-care6. Current treatment guidelines for MASH recommend imaging-based elastography, such as Velacur™, to assess liver scarring (fibrosis) and fat content (steatosis). While ultrasound elastography is widely used, when it comes to treating patients with MASH, liver stiffness alone cannot be relied on to assess treatment response in the short term7. The best predictor of treatment responses was a decrease in steatosis (identified as ≥30% reduction in MRI-PDFF)8.

VDFF, Sonic Incytes’ proprietary algorithm that received FDA clearance in 2024, demonstrates a strong correlation (r = 0.85) with MRI-PDFF—the gold standard for liver fat measurement—and achieves an outstanding accuracy (AUC) of 95% of patients with more than 5% MRI-PDFF, defining the presence of hepatic steatosis9. Velacur ONE™ combines this technology with a refined user interface, including B-mode imaging—enabling 3–4x higher reimbursement than non-imaging elastography—and an AI-based organ overlay feature to aid in liver localization, making it the only point-of-care device that estimates both liver stiffness and attenuation that correlates to MRI-PDFF10.

“The launch of Velacur ONE™ marks a pivotal milestone for Sonic Incytes as we accelerate our US and global commercial expansion strategy,” said Barry Allen, CEO of Sonic Incytes. “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.”

About Sonic Incytes

Sonic Incytes is committed to enhancing patient care through innovative diagnostic solutions. The company’s flagship product, Velacur™, equips physicians with an advanced liver imaging tool to help manage the growing epidemic of fatty liver disease. Velacur™ offers real-time, AI-guided quantification of the key markers for fatty liver disease: liver stiffness, attenuation and VDFF. With real-time results, a low up-front cost and AI guidance, Velacur™ makes liver imaging at the point-of-care affordable and accessible.

For more information, visit www.sonicincytes.com.

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1 American Liver Foundation. (2025, June). Nonalcoholic fatty liver disease (NAFLD). American Liver Foundation
2 Le P, Tatar M, Dasarathy S, et al. Estimated Burden of Metabolic Dysfunction–Associated Steatotic Liver Disease in US Adults, 2020 to 2050. JAMA Netw Open. 2025;8(1):e2454707. doi:10.1001/jamanetworkopen.2024.54707

3 Fishman, J., Kim, Y., Charlton, M.R. et al. Estimation of the Eligible Population For Resmetirom Among Adults in the United States for Treatment of Non-Cirrhotic NASH with Moderate-to-Advanced Liver Fibrosis. Adv Ther 41, 4172–4190 (2024). https://doi.org/10.1007/s12325-024-02989-5

4 Friedman SL. Fat, fibrosis, and the future: navigating the maze of MASLD/MASH. J Clin Invest. 2025 Apr 1;135(7):e186418. doi: 10.1172/JCI186418. PMID: 40166940; PMCID: PMC11957683.
5 Fishman J, Alexander T, Kim Y, Kindt I, Mendez P. A clinical decision support tool for metabolic dysfunction-associated steatohepatitis in real-world clinical settings: a mixed-method implementation research study protocol. J Comp Eff Res. 2024 Oct;13(10):e240085. doi: 10.57264/cer-2024-0085. Epub 2024 Sep 20. PMID: 39301878; PMCID: PMC11426282.

6 Gbadamosi, S. O., Evans, K. A., Brady, B. L., & Hoovler, A. (2025). Noninvasive tests and diagnostic pathways to MASH diagnosis in the United States: a retrospective observational study. Journal of Medical Economics, 28(1), 314–322. https://doi.org/10.1080/13696998.2025.2468582

7 Noureddin, M., Charlton, M. R., Harrison, S. A., Bansal, M. B., Alkhouri, N., Loomba, R., Sanyal, A. J., & Rinella, M. E. (2024). Expert panel recommendations: Practical clinical applications for initiating and monitoring resmetirom in patients with MASH/NASH and moderate to noncirrhotic advanced fibrosis. Clinical Gastroenterology and Hepatology, 22(12), 2367–2377.
8 Chen VL, Morgan TR, Rotman Y, Patton HM, Cusi K, Kanwal F, Kim WR. Resmetirom therapy for metabolic dysfunction-associated steatotic liver disease: October 2024 updates to AASLD Practice Guidance. Hepatology. 2025 Jan 1;81(1):312-320. doi: 10.1097/HEP.0000000000001112. Epub 2024 Oct 18. Erratum in: Hepatology. 2025 Apr 1;81(4):E133.
9 Honarvar, M., Lobo, J., Schneider, C., Klein, S., Smith, G. I., Loomba, R., Ramji, A., Hassanein, T., Yoshida, E. M., Pang, E., Curry, M. P., & Afdhal, N. H. (2024). Methods and validation of Velacur determined fat fraction in patients with MASLD. WFUMB Ultrasound Open, 2(2), Article 100061.

 

The launch of Velacur ONE™ marks a pivotal milestone for Sonic Incytes as we accelerate our US and global commercial expansion strategy.

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