CDM Insights
Oxford Brain Diagnostics LtdCDM Insights is a software tool that helps trained healthcare practitioners analyze brain MRI scans of adults over 45 years old. It automatically segments and quantifies brain structures and white matter hyperintensities, compares findings with normative data from healthy populations, and provides easy-to-understand visual and numerical reports. This aids clinicians in evaluating neurological conditions more accurately and efficiently.
Intended Use
CDM Insights is a post-processing image analysis software that assists trained healthcare practitioners in viewing, analyzing, and evaluating MR brain images of adults > 45 years of age. It performs automated segmentation and quantitative analysis of brain structures and white matter hyperintensities, compares values with normative data from a healthy population, and provides results including numerical values and visualizations for reporting.
Technology
CDM Insights is an automated post-processing medical software device that accepts DICOM MR brain images, performs automatic segmentation and quantification of brain structures and lesions, conducts diffusion-weighted MRI (DWI) data analysis, compares image metrics from multiple time-points, and provides output as numerical values and DICOM-encapsulated PDF reports. It is deployed as a cloud solution and designed for radiologists and neurologists familiar with MR image post-processing.
Performance
Performance testing involved accuracy assessment against manual segmentation by certified neuroradiologists on 60 cases, demonstrating mean Dice scores above acceptance criteria for brain regions and white matter hyperintensities. Repeatability was confirmed on 121 healthy individuals with repeated scans. Reproducibility was validated on over 1500 subjects aged 45-90 years across different MRI scanners and protocols. Statistical accuracy of normative percentile data was tested on nearly 2000 independent test scans. All tests passed acceptance criteria, supporting substantial equivalence and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/11/2024
9 months - 2
FDA Approval
12/6/2024
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