SyntheticMR: MAGiC receives FDA approval

As previously communicated, SyntheticMR’s partner GE Healthcare has announced that MAGiC is now 510(k) cleared by the U.S. FDA. MAGiC is a customized version of SyntheticMR’s SyMRI® IMAGE software marketed by GE Healthcare under a license agreement.

“FDA clearance of MAGiC is a very important step and a significant achievement by our partner GE Healthcare. The U.S. market alone is the largest MRI market globally. FDA clearance means that MAGiC now has regulatory approval and is available for sale on most major markets globally”, says Stefan Tell, CEO of SyntheticMR.

MAGiC (Magnetic Resonance Image Compilation) is the industry’s first multi-contrast magnetic resonance (MR) technique now cleared with the U.S. FDA. The technique gives clinicians more data than conventional scanning in a fraction of the time*. MAGiC gives users the flexibility to manipulate the images retrospectively leading to significant timesaving, fewer rescans and therefore cost savings, which combined, can assist the clinician in making a more decisive diagnosis. 

GE Healthcare has conducted a blinded, mulit-center, multi-reader clinical study that compares MAGiC to conventional MRI. Clinicians from six different sites compared the two methods and verified that the image quality of MAGiC was comparable to conventional images at a fraction of the scan time.

Eric Stahre, president and CEO of GE Healthcare MR comments that “MAGiC is a terrific clinical innovation. This study proves that this technique can improve the way clinicians conduct neuro scans and diagnose their patients. Neuro scans are approximately thirty percent of all MR scans; therefore MAGiC could have a tremendous impact on the MR community. GE Healthcare is committed to delivering industry-leading MR innovations that advance clinical care. We are very excited to be the first company to bring MAGiC to market for our customers and their patients.”

* Based on MAGiC clinical study of 109 patients from 6 separate institutions.

Read press release from GE Healthcare here:

For further information, please contact Maria Wrethag, CMO and Head of Investor Relations SyntheticMR AB, +46 76 119 1983, or Stefan Tell, CEO SyntheticMR AB, +46 73 373 4090.

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 scan. SyMRI IMAGE provides fast MRI workflows, allowing high patient throughput. SyMRI NEURO enables automatic segmentation of brain tissue, providing objective decision support. SyMRI Research Edition includes exportable SyMaps™, quantitative T1, T2 and PD maps of the brain, allowing the investigation to be taken even further. SyMRI is CE-marked product. SyMRI is a registered trademark in Europe and in the USA. SyntheticMR is listed on the AktieTorget exchange in Stockholm, Sweden. For additional information, please visit . 

  Further information about SyntheticMR

Publicerat: 9/9/2016 9:54:18 AM

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