Latest news with #chronicliverdisease
National Post
6 days ago
- Health
- National Post
FDA Grants 510(k) Clearance for Sonic Incytes' Velacur ONE™, AI-Guided Point of Care Ultrasound for the Management of Chronic Liver Diseases
Article content VANCOUVER, British Columbia — 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. Article content 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 MASH 2. Yet, 90% of MASH cases remain undiagnosed 3. If left untreated, worsening MASH increases morbidity and may progress to severe complications, including cirrhosis, liver failure, liver cancer, and liver transplant 4,5. MASH remains challenging to diagnose effectively due to the limitations of existing non-invasive methods, especially those available at the point-of-care. Article content 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-care 6. 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 term 7. The best predictor of treatment responses was a decrease in steatosis (identified as ≥30% reduction in MRI-PDFF) 8. Article content 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 steatosis 9. 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-PDFF 10. Article content 'The launch of Velacur ONE™ marks a pivotal milestone for Sonic Incytes as we accelerate our US and global commercial expansion strategy,' Article content said Barry Allen, CEO of Sonic Incytes Article content . '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. Article content ' Article content About Sonic Incytes Article content 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. Article content ________________________________ 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). 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. 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. Article content Article content Article content Article content Article content Article content
Medscape
06-08-2025
- Health
- Medscape
Social Isolation Tied to Higher Mortality in Liver Disease
TOPLINE: Among adults with chronic liver disease, social isolation from living alone was associated with a 40% increased risk for all-cause mortality and with greater odds of food and healthcare-related transportation insecurity. METHODOLOGY: Researchers conducted a study to examine whether social isolation increases the risk for mortality in US adults with chronic liver disease and to explore the association of social isolation with food insecurity and healthcare-related transportation insecurity. They analyzed 2014-2018 National Health Interview Survey data from 3676 adults aged 18 years or older with self-reported chronic liver disease. Social isolation was defined as living alone. Food insecurity was assessed using a 10-item questionnaire, and healthcare-related transportation insecurity was defined as delayed access to medical care due to a lack of transportation. Participants were followed from their interview date until death or the study's end in December 2019. The mortality data were linked to the US National Death Index. TAKEAWAY: Among US adults with chronic liver disease, 22% reported experiencing social isolation from living alone. Social isolation was associated with 60% increased odds of food insecurity and 70% increased odds of healthcare-related transportation insecurity. Social isolation was also independently associated with a 40% increased risk for all-cause mortality after adjusting for food and healthcare-related transportation insecurity and various sociodemographic and clinical variables. IN PRACTICE: 'We hypothesize that social isolation from living alone may increase mortality risk in adults with CLD [chronic liver disease] due to lack of support for managing disease-specific complications and functional limitations in the home setting,' the authors wrote. 'Routine screening for social isolation during clinic visits could help identify at-risk patients, facilitating early interventions.' SOURCE: This study, led by Tiana Walker, MD, Massachusetts General Hospital, Harvard Medical School, Boston, was published online in Clinical Gastroenterology and Hepatology. LIMITATIONS: The study's limitations included its cross-sectional design, which limits casual analysis, and use of self-reported chronic liver disease, which may result in misclassifications and prevents analysis related to the cause and severity of liver disease. Additionally, living alone does not fully capture social isolation, loneliness, or social support. DISCLOSURES: This study was supported by a Sojourns Scholar Award from the Cambia Health Foundation. The authors declared having no relevant conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
09-05-2025
- Health
- Medscape
Non-Invasive Scores May Aid in Distinguishing Liver Diseases
Non-invasive biomarkers and scoring systems demonstrated effectiveness in differentiating chronic liver disease (CLD) from cirrhosis; non-invasive fibrosis scores such as the Lok index, King's score, fibrosis index, and non-alcoholic fatty liver disease fibrosis score (NFS) showed strong capability. METHODOLOGY: Researchers compared cirrhosis with CLD caused by viral infections, autoimmune conditions, and primary biliary cholangitis, focusing on the comparison of different biomarkers and non-invasive scores and their utility in predicting hepatic steatosis and liver fibrosis. They conducted a retrospective observational study at a hospital in Romania from January 2021 to December 2023 and included 250 adult patients (median age, 64 years) with a confirmed diagnosis of liver disease. Blood samples were collected during standard clinical evaluations, and a series of tests were conducted. The analysis incorporated multiple non-invasive scoring systems, including the fibrosis-4 index; King's score for liver fibrosis; Lok index for liver fibrosis; and various haemogram-derived ratios, such as neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and lymphocyte-to-monocyte ratio. The receiver operating characteristic curve analysis was performed to assess the effectiveness of the scores and haemogram-derived ratios in differentiating CLD from cirrhosis. TAKEAWAY: Among the 250 participants, 113 had CLD without cirrhosis (72.57% women) and 137 had liver cirrhosis (34.31% women). Albumin-bilirubin scores and the risk for mortality were significantly higher in the cirrhosis group than in the CLD group ( P < .001 for both). < .001 for both). The Lok index demonstrated superior diagnostic accuracy (area under the curve [AUC], 0.89; sensitivity, 86.61%; specificity, 78.85%). Moreover, strong discriminatory power was shown by non-invasive markers, including the King's score (AUC, 0.864), fibrosis index (AUC, 0.856), and NFS (AUC, 0.836). Patients with cirrhosis had a higher neutrophil-to-lymphocyte ratio ( P < .001) and a lower platelet-to-lymphocyte ratio ( P = .002) than those with CLD. IN PRACTICE: "[The study] findings have important clinical implications, particularly in tailoring non-invasive diagnostic strategies to specific patient populations," the authors wrote. "Collectively, these findings may support a more nuanced, etiology-aware application of non-invasive fibrosis scores and inflammatory indices in clinical hepatology," they added. SOURCE: This study was led by Abdulrahman Ismaiel, 2nd Department of Internal Medicine, "Iuliu Haţieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania. It was published online on April 29, 2025, in the Journal of Clinical Medicine . LIMITATIONS: The study's retrospective design limited causal inferences, and its single-centre nature may have affected generalisability. The lack of long-term follow-up data prevented the assessment of clinical outcomes like decompensation and mortality. Additionally, imaging techniques for the evaluation of liver fibrosis were not incorporated. DISCLOSURES: This research was partially funded by an internal grant from the "Iuliu Haţieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania. The authors reported having no conflicts of interest.
