AI-Rad Companion Brain MR
Siemens Medical Solutions U.S.A.AI-Rad Companion Brain MR is a software tool that helps clinicians by automatically analyzing MRI brain images. It segments and measures brain structures and white matter hyperintensities, compares these measurements with healthy reference data, and visually presents the results. This assists in evaluating brain changes over time, improving diagnostic workflow and patient monitoring in neurological conditions.
Intended Use
AI-Rad Companion Brain MR is a post-processing image analysis software that assists clinicians in viewing, analyzing, and evaluating MR brain images, providing automated segmentation and quantitative analysis of individual brain structures and white matter hyperintensities, quantitative comparison with normative data, and comprehensive reporting.
Technology
The software utilizes AI and automated image processing to segment and quantify brain structures and white matter hyperintensities from MRI T1 MPRAGE and T2 FLAIR images. It provides volumetric analysis, deviation mapping versus normative data, and follow-up features calculating atrophy and lesion progression. The deployment supports cloud-based and on-premises edge processing with outputs in DICOM formats.
Performance
Nonclinical performance testing including software validation, bench tests, and scientific evaluation demonstrated that the software meets performance acceptance criteria for volumetric, voxel-wise, and lesion-wise segmentation accuracy on a dataset of 75 subjects (MS and Alzheimer's) with results comparable to predicate devices. Risk management and cybersecurity measures conform to FDA guidance and recognized standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/1/2023
2 months - 2
FDA Approval
10/23/2023
Other devices from Siemens Medical Solutions U.S.A.
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