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 — 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). 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.
Article content
Article content
Article content
Article content
Article content
Article content
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
CTV News
5 minutes ago
- CTV News
Doctors are seeing more non-smokers, especially women, with later-stage lung cancer
Katie Hulan, 37, is one of a growing number of non-smoking women doctors are seeing who have lung cancer. Hulan is seen in an undated handout photo. THE CANADIAN PRESS/Handout - Mohammed Asaduallah (Mandatory Credit) TORONTO — Katie Hulan's family doctor thought she might have asthma. Her cough, which had started about a month and a half earlier, was getting progressively worse. So he gave her some puffers to try, but they didn't work. 'I was just getting to the point where I couldn't speak at work,' said the 37-year-old tech marketing manager. 'At the end of the day, I would be in pain just from the shaking and coughing.' Her doctor ordered an X-ray that showed a mass on her lung. '(My doctor) said to go to emergency, thinking it was a blood clot,' Hulan remembers. After about six hours of more tests, they told her she had stage 4 lung cancer. 'That was one of the most devastating moments of my life,' she said. 'My immediate reaction was, 'I know how this story ends.' And so for me, it just felt completely like a death sentence.' She had been healthy, active and didn't smoke. 'For me to get a cancer diagnosis was a big shock. And then to have a lung cancer diagnosis was very puzzling for me,' said Hulan, who was diagnosed in Toronto in late 2020 and has since moved to Victoria where she continues treatment. She's one of a growing number of non-smokers doctors are seeing with lung cancer. Although smoking remains the leading risk factor, the Canadian Cancer Society estimates about a quarter of lung cancer cases in the country are non-smokers. In addition, more of those non-smokers are women than men and it's not clear why, said Jessica Moffatt, vice-president of programs and advocacy at the Lung Health Foundation. 'One of the theories is that potentially estrogen is doing something to perpetuate tumour growth, but it's all theories at this point,' she said. What scientists do know is that environmental factors contribute to lung cancer risk, especially radon gas. According to Health Canada, long-term exposure to radon — an invisible, radioactive gas from the breakdown of uranium in soil and rocks — is the number one cause of lung cancer among non-smokers. The agency says radon is present to some degree in every home and urges everyone to get a radon test kit to check their levels. Other risk factors include exposure to second-hand smoke, asbestos and the fine particulate matter in air pollution, Moffatt said. As wildfires rage across the country, the effects of that smoke is 'a huge concern for us' and is an area being studied to determine lung cancer risk, she said. Dr. Rosalyn Juergens, a medical oncologist at McMaster University and Hamilton Health Sciences Centre, said studies have shown that people living in areas with high air pollution rates have a higher risk of developing lung cancer. Over about 20 years in practice, she has 'absolutely' seen a rise in non-smoking lung cancer patients. 'It was uncommon for me, not never, but uncommon for me, to see a never-smoker when I first started in practice. And we are definitely seeing more and more,' said Juergens, who is also the president of Lung Cancer Canada. It's not clear whether there are more non-smokers getting lung cancer or if they just make up a greater proportion of the patients as fewer people smoke than ever before, she said. Many of her non-smoking patients are women, but people simply aren't aware of lung cancer as a women's health issue, she said. When non-smokers reach her office, their cancer is often in advanced stages. 'More women will die of lung cancer than will die of breast cancer, ovarian cancer, and cervical cancer combined,' Juergens said. 'One in five of them will be people who have never touched a cigarette a day in their lives.' Although organized lung cancer screening programs have been running in British Columbia, Ontario and Nova Scotia since 2022, they only target smokers, so non-smokers don't get the benefit of that early detection. In addition, lung cancer is often not top-of-mind for primary-care providers when non-smoking patients come in with a cough, Juergens said. 'The tricky part about lung cancer is symptoms are generally very subtle, right? Your lungs inside don't have nerve endings. So it's not like you're going to get a pain. You're never going to feel a lump,' she said. But the good news for many patients, Juergens said, is that lung cancer treatment has advanced dramatically since the 1990s, when chemotherapy was often the only option. 'We do things called next generation sequencing on the vast majority of lung cancers, and that helps us to sort what exact type of lung cancer it is and pick the right treatments,' she said. That precision medicine turned Katie Hulan's initial life expectancy of six months into an average of five to six years. A biopsy showed that her cancer had an ALK genetic mutation — one of about a dozen biomarkers that have specific medications to target the cancerous cells, and is only present in about four per cent of cases. 'When I got that news, it felt like a 180. I had life. I had hope. You know, my oncologist sat down and said, 'you won the lottery, you have years,'' she said. Almost five years after her diagnosis, Hulan continues to take a pill as her treatment, never had to undergo chemotherapy, feels 'wonderful' and is determined to live a long, full life. She now does advocacy work for the Lung Health Foundation to call for equal access to targeted cancer medication across the country and to urge people to seek medical attention if they have a cough that lasts more than two or three weeks. 'I think the word on the street is that you have to be a person who has smoked and that's not at all the case,' she said. 'Anyone with lungs can get lung cancer.' This report by The Canadian Press was first published Aug. 18, 2025. Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content. Nicole Ireland, The Canadian Press
CBC
8 minutes ago
- CBC
Fast-spreading fungus deadly to endangered butternut trees attacking 3 areas of P.E.I.
Islanders are being urged to take precautions to prevent the spread of a tree fungus that has now been detected in three areas of P.E.I. Butternut canker is a fast-spreading disease that attacks butternut trees. While the trees are not believed to be native to the Island, they are widely planted across the province. "It is really a death sentence, unfortunately, for the tree once it receives butternut canker," said Clay Cutting, a technician with the P.E.I. Invasive Species Council. Once the tree is infected, there is no known way to stop the fungus's spread — eventually, the host tree dies when multiple cankers work in conjunction to girdle the tree. Cutting said the council is well aware of how devastating the fungus can be to butternut tree populations because of how the disease has impacted other provinces. According to a news release from the P.E.I. Invasive Species Council, over 80 per cent of butternut trees in Ontario have been killed by butternut canker to date, with an overall infection rate of more than 99 per cent. Symptoms and signs The fungus was first observed in trees in Stratford's Robert Cotton Park in 2024. Since then, the invasive species council conducted surveys on butternut trees in Charlottetown and Stratford and found that a majority "demonstrated signs of butternut canker infection," according to the news release. Scientists with the Canadian Forest Service confirmed the identification of the disease in July. "The most obvious sign and symptoms of butternut canker are those large, sunken cankers that appear on the trunks in the branches. They're mostly elongated, and the cankers exude a black substance," Cutting said. He said the appearance of the fungus can differ based on how long the tree has been infected, and the time of year. The colouring of the infected area can range from black to dark brown. In newer cases, the symptoms are not as obvious and can look like raised patches with small cracks in the bark that exude a black substance. How does it spread? The only confirmed way butternut canker spreads is through rainfall, Cutting said. "The rainwater will hit an infected tree, maybe spread that around the canopy, splashing fungal spores around the canopy." He's not ruling out other methods of spread like the handling of firewood, or insects and birds coming into contact with the fungus. There are no known control methods for affected populations, and butternut trees' endangered status may limit their removal based on P.E.I.'s Wildlife Conservation Act regulations. The invasive species council said Islanders can take steps to care for certain trees that have show a higher level of tolerance to the disease. This can be done by pruning out infected branches and removing cankers to help minimize the amount of the fungus in the area to potentially extend the tree's lifespan.
CBC
36 minutes ago
- CBC
Manitoba updating RSV immunization program, with no commitment to making it universal
The Manitoba government plans on updating its RSV immunization program this fall, but the province is not committing to following the majority of Canada in extending the preventative treatment to all newborns and young children.
