BrainInsight is a software tool designed to analyze low-field MRI brain scans automatically. It uses machine learning to segment brain structures, measure volumes, and provide annotated images and reports to assist clinicians in evaluating brain anatomy quickly and efficiently.
Automatic labeling, spatial measurement, and volumetric quantification of brain structures from a set of low-field MR images, returning annotated and segmented images, color overlays, and reports.
BrainInsight is a fully automated MR imaging post-processing software that uses a proprietary internal pipeline incorporating machine learning for brain segmentation, ventricle segmentation, and midline shift measurements. It operates on standard computing platforms or cloud servers and supports DICOM input and output formats, providing volumetric measurements, segmented color overlays, and morphometric reports.
Performance testing included software evaluations to confirm cybersecurity, data protection, segmentation accuracy, midline shift measurements, 3D coordinate alignment, ventricle segmentation, skull stripping, data quality control, audit trails, and software controls. No clinical data were required for equivalence.
No predicate devices specified
Submission
8/24/2020
FDA Approval
1/7/2021
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