CorInsights MRI
ADM Diagnostics, Inc.CorInsights MRI is an automated software that processes brain MRI scans to identify and measure brain structures. It helps clinicians by providing detailed volumetric reports comparing patient brain volumes to normal reference data, aiding in research and clinical assessment of neurologic conditions in adults 45 to 95 years old.
Intended Use
The CorInsights MRI Medical Image Processing Software is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from MRI images. Volumetric measurements are compared to reference percentile data. CorInsights MRI is for adults age 45 to 95.
Technology
CorInsights MRI is an automated MR image processing software that uses a proprietary internal process including artifact correction, atlas-based segmentation, volume calculation, and report generation. It inputs DICOM MRI images and outputs annotated images and morphometric reports comparing volumes to reference data.
Performance
Performance testing included accuracy validation against expert ground truth segmentations with high ICC (0.89-0.99) and DICE scores (81%-95%), reproducibility testing with ICC of 0.97, and validation across diverse clinical diagnoses and scanner types. Over 1,400 scans from 1,100+ subjects were analyzed showing safe and effective volumetry.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/27/2019
11 months - 2
FDA Approval
11/20/2020
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