BrainInsight
Hyperfine, Inc.BrainInsight is a software product from Hyperfine, Inc. that automatically processes low-field MR brain images to label, segment, and measure brain structures. It provides physicians with annotated images, color overlays, and reports that help in evaluating brain anatomy and pathology more efficiently. The system is cloud-based and integrates with FDA-cleared PACS systems to seamlessly assist clinical workflows.
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 uses a proprietary automated internal pipeline based on machine learning to process low-field MR images, performing segmentation, volume calculation, distance measurement, and generating color overlays and reports. It operates as cloud-based software compatible with FDA-cleared PACS and supports DICOM image input and output.
Performance
Performance testing included software verification per IEC 62304:2006, training on multi-site annotated datasets of low-field MRI scans including stroke, hemorrhage, and tumor pathology. Validation showed high agreement with expert annotations (Dice coefficients around 80-95%) and accurate midline shift measurements (mean error ~1 mm), meeting all acceptance criteria for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/21/2022
4 months - 2
FDA Approval
7/19/2022
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