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SyntheticMR gets FDA nod for quantitative syMRI 3D software

by John R. Fischer, Senior Reporter | March 29, 2024
Artificial Intelligence MRI
SyntheticMR's SyMRI 3D software
SyntheticMR has scored 510(k) clearance for its next-generation quantitative MR software, SyMRI 3D, equipped with isotropic 3D resolution to more precisely estimate brain region volume and improve lesion analysis.

More accurately depicting volumes of different brain regions, a technique known as parcellation, will allow clinicians to better study brain structure and function. Enhanced lesion analysis will make for more accurate and in-depth assessments of medical conditions.

SyntheticMR expects the technology to make it feasible to perform more precise diagnosis, treatment planning, and monitoring, according to Jared Dixon, president of SyntheticMR U.S. Inc.
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"Receiving 510(k) clearance for SyMRI 3D allows us to empower physicians to make more precise and informed decisions in diagnosis and treatment planning through quantitative imaging," he said in a statement.

The company’s flagship product, SyMRI, applies AI to produce multiple, adjustable contrast images and quantitative data from single five-minute scans. It comes in three packages, one for improved workflow, another for automatic decision support in brain tissue imaging, and a third for exporting quantitative T1, T2, and PD maps of the brain.

The company also designs SyMRI NEURO, a software that delivers multiple contrast images, tissue segmentations, and quantitative data on the brain, and SyMRI MSK, which does the same for knee and spine anatomies.

Just this past month, it announced the debut of another new product Smart Quant Neuro 3D, developed in conjunction with Philips. The solution makes recommendations based on automated quantitative measurements taken of various brain tissues to assess brain disease and progression. It also monitors the effects of therapy to suggest necessary adjustments in treatment, and forms objective assessments of and differentiates traumatic brain injuries from other neurological conditions.

SyMRI 3D is already CE-marked.

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