FDA Clears Sonic Incytes' AI-Guided Velacur ONE Ultrasound Device for Chronic Liver Disease Management
核心洞察
The FDA has granted 510(k) clearance for Sonic Incytes' Velacur ONE, an enhanced AI-guided point-of-care ultrasound elastography device for managing chronic liver diseases including MASH (搜索) and MASLD (搜索).
The device addresses a critical diagnostic gap, as 90% of MASH (搜索) cases remain undiagnosed among the estimated 15-20 million Americans affected by this progressive liver disease.
Velacur ONE's proprietary VDFF algorithm demonstrates strong correlation with MRI-PDFF (r = 0.85) and achieves 95% accuracy in detecting hepatic steatosis (搜索), making it the only point-of-care device to estimate both liver stiffness and fat content.
The U.S. Food and Drug Administration has granted 510(k) clearance for Sonic Incytes Medical Corp (搜索)'s Velacur ONE, an AI-guided point-of-care ultrasound elastography device designed to improve the management of chronic liver diseases, including metabolic dysfunction-associated steatohepatitis (搜索) (MASH (搜索)) and metabolic dysfunction-associated steatotic liver disease (搜索) (MASLD (搜索)).
The enhanced device builds upon Sonic Incytes' original Velacur model, introducing improved portability, an enhanced user interface, and advanced features to support the company's accelerated U.S. and global expansion strategy. Velacur ONE measures attenuation, VDFF (Velacur Determined-Fat Fraction), and liver stiffness using 3D S-WAVE technology.
Addressing Critical Diagnostic Gaps
The clearance comes at a pivotal time following the recent FDA approval of Rezdiffra, the first therapeutic for MASH (搜索). Despite affecting an estimated 100 million adults with MASLD (搜索) in the U.S., with 15-20 million having MASH, approximately 90% of MASH cases remain undiagnosed. Left untreated, MASH can progress to severe complications including cirrhosis (搜索), liver failure (搜索), liver cancer (搜索), and the need for liver transplant.
"MASH (搜索) remains challenging to diagnose effectively due to the limitations of existing non-invasive methods, especially those available at the point-of-care," according to the company's announcement. With therapeutic options now available and more in development, clinicians require improved non-invasive tests to diagnose and monitor MASH at the point of care.
Advanced Diagnostic Capabilities
Current treatment guidelines for MASH (搜索) recommend imaging-based elastography to assess liver scarring (fibrosis) and fat content (steatosis). However, liver stiffness alone cannot reliably assess treatment response in the short term. Research indicates that the best predictor of treatment response is a decrease in steatosis, specifically a ≥30% reduction in MRI-PDFF.
Velacur ONE's proprietary VDFF algorithm, which received FDA clearance in 2024, demonstrates a strong correlation (r = 0.85) with MRI-PDFF—the gold standard for liver fat measurement—and achieves 95% accuracy in identifying patients with more than 5% MRI-PDFF, which defines the presence of hepatic steatosis (搜索).
The device combines this technology with a refined user interface, including B-mode imaging that enables 3-4x higher reimbursement than non-imaging elastography, and an AI-based organ overlay feature to aid in liver localization. This makes Velacur ONE the only point-of-care device that estimates both liver stiffness and attenuation that correlates to MRI-PDFF.
Commercial Expansion Strategy
"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 (搜索) and MASH (搜索) at the point-of-care."
Sonic Incytes positions itself as committed to enhancing patient care through innovative diagnostic solutions, with Velacur technology offering real-time, AI-guided quantification of key markers for fatty liver disease. The company emphasizes that its devices make liver imaging at the point-of-care both affordable and accessible through real-time results, low upfront costs, and AI guidance.