SyntheticMR Announces Submission of 510(k) to FDA for Quantitative MSK MRI Package
A 6-minute scan can now provide multiple contrast images, and 5 quantitative tissue maps for MSK anatomies, including spine, knee, pelvis, ankles and shoulders.
SyntheticMR, an innovative software solutions company for magnetic resonance imaging (MRI) announced today the Company filed a 510(k) submission for its musculoskeletal solutions package, SyMRI® MSK.
“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.”
Like its neuro counterpart, the SyMRI® MSK package provides radiologists a solution-based approach by offering 6-minute scans that can drastically improve patient throughput, produce a range of contrast-weighted images, as well as quantitative T1, T2, and PD maps for both clinical and research practices for all MSK anatomies and joints – including spine.
“Most people will experience joint or back pain at some point of their lives,” explains Kyle Frye, President of SyntheticMR US. “While it’s routine to use MRI to help physicians diagnose issues relative to the knee, shoulder, ankle, and spine, now we are taking it to the next level by providing a quantitative approach. In other words, we’re helping move from a subjective environment to one that is objective. And that’s something we are truly excited about.”
SyMRI® MSK uses a unique scanning sequence to measure the absolute properties of the anatomy and joins the SyntheticMR’s growing portfolio of quantitative software solutions, which includes SyMRI® NEURO.
For additional information, please contact Ulrik Harrysson, CEO, SyntheticMR AB, +46 70 529 29 87 ulrik.harrysson@syntheticmr.com or Kyle Frye, President SyntheticMR Inc. at +1 (859) 512-9496 or kyle.frye@syntheticmr.com.
SyntheticMR AB develops and markets innovative software solutions for Magnetic Resonance Imaging (MRI). SyntheticMR AB has developed SyMRI®, delivering multiple, adjustable contrast images and quantitative data from a single 6-minute scan. The SyMRI product is available in different packages. SyMRI NEURO delivers multiple contrast images, tissue segmentations and quantitative data on the brain. SyMRI MSK provides multiple contrast images and quantitative data for MSK anatomies. SyMRI NEURO is CE-marked and FDA 510(k) cleared and SyMRI MSK is FDA 510(k) pending. SyMRI is a registered trademark in Europe and the USA. SyntheticMR is listed on the Spotlight Stock Market Exchange in Stockholm, Sweden.