Velacur
Sonic IncytesVelacur is a portable ultrasound elastography device designed to assist clinicians in the assessment of liver diseases. It non-invasively measures liver tissue stiffness and fat content by analyzing shear wave speed and ultrasound attenuation, helping in the management of conditions such as hepatic steatosis. The device incorporates AI algorithms to improve image quality and accuracy of liver tissue characterization.
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). The device is indicated to non-invasively determine liver tissue stiffness, attenuation, and Velacur Determined Fat Fraction to aid clinical management of patients with liver diseases including hepatic steatosis.
Technology
Velacur is a portable ultrasound elastography system that uses mechanically generated shear waves and ultrasound transducer measurements to calculate liver tissue stiffness and attenuation. It employs AI algorithms including organ guide extension for liver and surrounding organ segmentation, and wave quality guide for assessing shear wave data quality.
Performance
Performance testing included validation of the Velacur Determined Fat Fraction algorithm against MRI-PDFF in patient cohorts, machine learning validation of organ guide and wave quality algorithms using thousands of images and patient data, and software verification and validation. The device demonstrated high correlation with MRI and high accuracy in segmentation tasks.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/18/2023
8 months - 2
FDA Approval
9/4/2024
Other devices from Sonic Incytes
- Velacur2023 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.