BrainInsight
Hyperfine, Inc.BrainInsight is an automated software that processes low-field MRI brain images to provide automatic labeling, spatial measurement, and volumetric quantification of brain structures. It produces annotated and segmented brain images with color overlays and detailed reports, helping clinicians assess brain anatomy and abnormalities efficiently, particularly using low-field MRIs.
Intended Use
BrainInsight is intended for automatic labeling, spatial measurement, and volumetric quantification of brain structures from a set of low-field MR images and returns annotated and segmented images, color overlays and reports.
Technology
BrainInsight is a fully automated MR imaging post-processing software that uses a proprietary automated internal pipeline based on machine learning tools to provide image alignment, segmentation, ventricle segmentation, and midline shift measurements from sets of low-field MRI images. It delivers annotated and segmented images with color overlays and reports in standard image formats compatible with PACS and third-party workstations. The software operates in a serverless cloud environment with user interface via PACS and supports Linux-based OS.
Performance
Performance testing included software verification per IEC 62304:2006 and FDA software guidance. The models were trained and validated on annotated multi-site datasets acquired from low-field MRI scanners. Quantitative evaluation compared model outputs to expert consensus annotations, showing that the model's performance for midline shift, lateral ventricles, and whole brain segmentation is statistically non-inferior to expert annotators. Dice overlap values range from 82-96% for ventricles and whole brain with volume differences comparable to expert variation. The testing supports safety and effectiveness with no issues identified.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/24/2022
1 month - 2
FDA Approval
12/16/2022
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