GE Healthcare Announces MAGiC Receives FDA Approval

STOCKHOLM–(BUSINESS WIRE)–As previously communicated, SyntheticMR’s partner GE Healthcare (NYSE:GE) 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: https://www.healthimaging.com/press-releases/magic-industry-first-multi-contrast-mri-saves-scan-time
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 www.syntheticmr.com.
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