SyMRI is a software tool that processes MRI data to generate detailed maps of brain tissue properties and volumetric measurements. It enables visualization of multiple image contrasts from a single MRI scan and allows clinicians to adjust image contrasts after acquisition. This helps in better diagnosis and understanding of brain health by providing comprehensive and quantifiable tissue information.
Intended Use
SyMRI is a post-processing software medical device intended for use in visualization of soft tissue, analyzing input data from MR imaging systems to generate parametric maps of R1, R2 relaxation rates, and proton density. It enables automatic labeling, visualization and volumetric quantification of segmentable brain tissues and can generate multiple image contrasts with post-acquisition contrast adjustment. It is indicated for head imaging and aids trained physicians in diagnosis interpretation.
Technology
SyMRI operates by post-processing multi-delay, multi-echo MR acquisitions (M2D-MDME and 3D-QALAS sequences) to produce parametric maps (R1, R2, PD) and synthetic contrast weighted images. It uses segmentation algorithms on parametric maps to quantify brain tissue volumes and supports post-acquisition contrast adjustment. It accepts sequence data from multiple MR vendors and produces outputs compatible with DICOM workstations and PACS.
Performance
Non-clinical verification confirmed accuracy and precision of R1, R2, and PD quantification comparable to gold standards and predicate device. Clinical testing in a prospective, multi-center study with 189 subjects and five radiologist readers demonstrated that synthetic 3D images produced by SyMRI are non-inferior to conventional 3D MR images in sensitivity, specificity, diagnostic accuracy, artifact prevalence, and anatomical legibility, supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/23/2024
3 months - 2
FDA Approval
12/6/2024
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