GBrain MRI
Galileo CDS, IncGBrain MRI is a software tool that automatically segments, quantifies, and reports the volume of signal hyperintensities in brain MR FLAIR images. It helps radiologists by providing quantitative measurements to support the evaluation of brain MRI scans, enhancing clinical assessment without replacing the physician's judgment.
Intended Use
GBrain MRI is a post processing medical device software intended for analyzing and quantitatively reporting signal hyperintensities in the brain on FLAIR MR images in the context of diagnostic radiology. It provides automatic segmentation, quantification, and reporting of derived image metrics and is not intended for specific disease diagnosis or signal hyperintensity detection.
Technology
The software uses a proprietary automated pipeline that includes skull stripping, signal normalization, deep learning-based segmentation of hyperintensities on T2w FLAIR brain MR images, volume calculations, and report generation, producing outputs in standard DICOM formats compatible with PACS systems. It operates without user interaction after installation and supports DICOM file transfers.
Performance
Performance testing compared automated segmentations to expert manual segmentations using consensus STAPLE algorithm, OLS Regression, and Dice similarity coefficient metrics to ensure clinically acceptable segmentation accuracy across multiple MRI scanner manufacturers and field strengths. The device met all acceptance criteria demonstrating safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/13/2025
1 month - 2
FDA Approval
4/11/2025
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