SyntheticMR announces submission of 510(k) to US FDA for musculoskeletal solutions package, SyMRI MSK

-By KI News Team | Nov. 19, 2020, 6:30 p.m.

SyntheticMR, an advanced magnetic resonance imaging (MRI) software solutions company, announced that the company has submitted a 510(k) application for its musculoskeletal solutions package, SyMRI MSK.

The software offers multiple-contrast images and quantitative details to radiologists that can be used in diagnosing problems with the knee, shoulder, ankle and spine.

SyMRI MSK conducts six-minute scans for musculoskeletal anatomies and joints, including the spine, that generate a range of contrast-weighted images and quantitative maps for clinical and research practices.

 “We are thrilled to receive 510(k) pending status for SyMRI MSK,” said Ulrik Harrysson, CEO, SyntheticMR. “In today’s environment, there is a clear demand for quantitative solutions in the musculoskeletal market and we believe that we have a unique opportunity to enable physicians to make better, more informed decisions using quantitative imaging in MSK applications.”

The SyMRI MSK kit, like its neuro equivalent, offers radiologists a solution-based approach by providing 6-minute scans that can dramatically increase patient throughput, generate a variety of contrast-weight images, including T1W, T2W, PDW and STIR as well as quantitative T1, T2, and PD maps for all MSK anatomies and joints, including spine, for both clinical and research practices.

SyMRI MSK uses a special scanning sequence to quantify the anatomy's absolute properties and joins the growing portfolio of quantitative software solutions that includes SyMRI NEURO from SyntheticMR. This allows the user to generate validated T2 maps for cartilage assessment with no additional scan time. The product produces T1 and PD maps in addition to the T2 map that can be used for deeper tissue analysis.

SyMRI for MSK anatomies is 510(k) pending and is not available for clinical use.

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