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SyntheticMR Seeks 510(k) Clearance for Next-Gen SyMRI 3D Solution

Wednesday, November 22, 2023

SyntheticMR recently unveiled that their advanced imaging solution, SyMRI 3D, featuring isotropic resolution, is presently in the process of FDA evaluation for clinical utilization in the United States. Representing a groundbreaking stride in medical imaging, SyMRI 3D introduces fresh avenues for diagnostic and therapeutic applications.

SyMRI 3D is poised to revolutionize the realm of medical imaging by introducing a range of innovative applications within the SyMRI post-processing framework. Notably, it offers precise volumetric estimations of brain regions, commonly referred to as parcellation, empowering clinicians with profound insights into both the structural and functional aspects of the brain.

The exceptional resolution of SyMRI 3D goes beyond, enabling thorough lesion analysis and ensuring a more accurate and comprehensive assessment of various medical conditions. This advanced SyMRI sequence introduces 3D resolution to quantitative values and tissue segmentations, maintaining the same high level of precision in quantification seen with SyMRI’s 2D imaging.

The anticipated 510(k) clearance for SyMRI 3D is set to empower physicians to make more informed decisions using quantitative imaging with SyMRI®, providing multiple contrast images and quantitative data from a single 5-minute scan. The SyMRI product is available in different packages, with SyMRI NEURO delivering multiple contrast images, tissue segmentations, and quantitative data for the brain, while SyMRI MSK does the same for knee and spine anatomies. SyMRI NEURO holds both CE-marking and FDA 510(k) clearance, and SyMRI MSK is CE-marked.


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