VBrain
Vysioneer Inc.VBrain is an AI-powered software device that helps trained medical professionals by automatically generating initial contours of known brain tumors on MRI scans. It supports radiation therapy planning by providing preliminary tumor outlines for professionals to review and adjust, streamlining the clinical workflow for brain tumor treatment planning.
Intended Use
VBrain is a software device intended to assist trained medical professionals, during their clinical workflows of radiation therapy treatment planning, by providing initial object contours of known (diagnosed) brain tumors on axial T1 contrast-enhanced brain MRI images.
Technology
VBrain uses image preprocessing, deep learning neural networks, and postprocessing to automatically contour known brain tumors on axial T1 contrast-enhanced MRI images and exports results as DICOM-RT objects for review and modification by medical professionals.
Performance
Performance testing was conducted on 116 cases from multiple institutions evaluating lesion-wise sensitivity, false-positive rate, Dice similarity coefficient, and Hausdorff and centroid distances, demonstrating that VBrain meets all performance goals and is substantially equivalent to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/3/2020
4 months - 2
FDA Approval
3/19/2021
Other devices from Vysioneer Inc.
- VBrain2021 • 510K
- VBrain-OAR2021 • 510K
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