Velacur One (LI-1100)
Sonic Incytes Medical CorpVelacur One (LI-1100) is a portable ultrasound elastography device designed to non-invasively assess liver tissue stiffness, ultrasound attenuation, and fat content by measuring shear wave speed and ultrasound properties. It assists trained clinicians in managing liver diseases including hepatic steatosis by providing quantitative imaging data at the point of care in clinics and hospitals.
Intended Use
Velacur is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz), ultrasound attenuation and Velacur Determined Fat Fraction (VDFF) to aid in clinical management of patients with liver diseases including hepatic steatosis.
Technology
The system uses an external shear wave generator to produce shear waves in the abdomen. Ultrasound imaging acquires data over a volume to measure tissue stiffness via shear modulus, attenuation, and fat fraction (VDFF) using analysis of RF data and backscatter measurements.
Performance
Performance was validated by bench testing on phantoms for liver stiffness, attenuation and fat fraction algorithms using accepted criteria. Human factors, software verification and hardware tests were also done. No new safety issues were identified and the device was found substantially equivalent to the predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/5/2025
21 days - 2
FDA Approval
6/26/2025
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