VINT is a software tool designed to assist clinicians in viewing, processing, and quantitatively evaluating cerebrovascular MRI images. It imports DICOM-formatted MR images and analyzes blood flow characteristics of cerebral arteries, including providing signal intensity gradient metrics from TOF-MRA scans. It supports advanced image corrections and data visualization, aiding radiologists in assessing cerebral artery health without the need for contrast medium.
Intended Use
VINT is a software that allows for the viewing, post-processing, and quantitative evaluation of cerebrovascular MRI data (in DICOM-compliant format). It enables importing DICOM-compliant MR Images, quantitative analysis of imported images, visualization and analysis of blood flow characteristics of cerebral arteries in MR images, advanced correction options such as offset correction, background phase correction, and anti-aliasing, data visualization as a graph or output as an image or numerical data, and provides the right and left carotid and vertebral arteries wall signal intensity gradient (SIG), an image-based indirect marker for velocity gradient from TOF-MRA. It is intended for use with adult (22 years or more) populations who can undergo MRA.
Technology
VINT is standalone medical software for processing, analyzing, viewing, and quantifying cerebral artery MR images. It supports 2D and 3D viewing, multiphase series, zoom, pan, rotate, and ROI markers for measurement and segmentation. It calculates signal intensity gradient (SIG) using semi-automatic segmentation with thresholding methods based on binary algorithms and provides heatmaps and numerical data. The software uses TOF-MRA data without contrast medium and applies advanced corrections such as offset and background phase correction, and anti-aliasing. It operates locally without sending patient data over networks, emphasizing security.
Performance
Bench testing was performed to evaluate arterial length, angle, radius, and volume metrics comparing VINT to predicate device A. Validation comparing velocity gradient from PC-MR and signal intensity gradient (SIG) from TOF-MRA was done with the reference device, showing a high correlation. Software validation and cybersecurity testing were conducted in compliance with IEC 62304 and FDA guidance. No clinical studies were performed but comparative verification confirmed the device is substantially equivalent and safe.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/8/2024
8 months - 2
FDA Approval
10/15/2024
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