Velacur ONE: Point-of-Care Elastography with AI Guidance
Sonic Incytes Medical Corp announced that the FDA has cleared Velacur ONE, a portable point-of-care ultrasound elastography device. The system builds on the company’s first-generation Velacur model and introduces a streamlined interface, enhanced portability, and AI-guided functions aimed at improving usability in routine clinical practice.
Velacur ONE measures three key liver parameters:
- Liver stiffness (fibrosis assessment)
- Attenuation (quantifying tissue changes)
- VDFF (Velacur Determined-Fat Fraction), a proprietary fat quantification metric
These measures are critical for the management of metabolic dysfunction–associated steatotic liver disease(MASLD) and metabolic dysfunction–associated steatohepatitis (MASH).
Clinical Need for Non-Invasive Liver Testing
The FDA clearance arrives shortly after the approval of Rezdiffra, the first therapeutic for MASH, highlighting the need for accessible diagnostic tools. In the United States, around 100 million adults are estimated to have MASLD, with 15–20 million affected by MASH. Despite this, 90% of MASH cases remain undiagnosed.
If untreated, MASH can progress to cirrhosis, liver failure, hepatocellular carcinoma, and liver transplantation. Non-invasive diagnostic methods are therefore essential for earlier detection and ongoing monitoring.
Current guidelines recommend imaging-based elastography for assessing liver fibrosis and steatosis. However, monitoring liver stiffness alone is insufficient for evaluating short-term treatment response. Recent studies indicate that reduction in steatosis is a more reliable predictor of therapy effectiveness.
VDFF Technology and MRI Correlation
Sonic Incytes’ VDFF algorithm, which received FDA clearance in 2024, demonstrated a strong correlation (r = 0.85) with MRI-PDFF, the reference standard for liver fat measurement. In validation studies, VDFF achieved an AUC of 95% in patients with hepatic steatosis (>5% MRI-PDFF). By combining VDFF with elastography, Velacur ONE offers a comprehensive point-of-care solution that aligns closely with MRI-based evaluation.
Enhanced Features and Clinical Value
Velacur ONE integrates:
- B-mode imaging, allowing 3-4 times higher reimbursement compared to non-imaging elastography
- AI-based organ overlay, designed to improve liver localization during scans
- Portable design to support broader clinical adoption
With these functions, Velacur ONE is currently the only point-of-care ultrasound system to provide both liver stiffness and attenuation metrics that correlate with MRI-PDFF.
Market Outlook
The availability of a validated, non-invasive, AI-guided device supports both the growing need for early detection and the introduction of new therapeutic strategies for liver disease. As MASH treatment pathways expand, tools such as Velacur ONE will be essential for guiding patient care and reducing reliance on invasive biopsies.
Source: Sonic Incytes Medical Corp
