Velacur
Sonic IncytesVelacur is a portable ultrasound device that measures the stiffness and attenuation of liver tissue by generating and analyzing shear waves using ultrasound imaging. It incorporates AI-based algorithms to assist clinicians in assessing liver disease by providing detailed tissue characterization, enhancing accuracy and ease of use 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 (40-70Hz) and coefficient of attenuation to non-invasively determine liver tissue stiffness and attenuation, assisting clinical management of patients with liver disease.
Technology
Velacur uses a vibration activation unit placed under the patient to generate shear waves in the liver, while an ultrasound transducer acquires volumetric scans over the intercostal space. Two deep learning-based algorithms perform liver segmentation and shear wave quality assessment to improve data acquisition for elasticity and attenuation calculation.
Performance
Performance was validated with non-clinical bench testing including phantom tests and volunteer studies, plus clinical testing on patients with liver disease using novice operators. AI algorithms for liver segmentation and shear wave quality were tested on large datasets from US and Canada with performance metrics such as Dice coefficient >0.7 and accuracy >80%, confirmed by expert truthing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/25/2022
5 months - 2
FDA Approval
4/20/2023
Other devices from Sonic Incytes
- Velacur2024 • 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.