Segmentation and quantification of brain tissue, and industry first myelin volume measurements in SyMRI now FDA cleared.
The new regulatory clearance from the American Food and Drug Administration, FDA, concerns the SyMRI NEURO product package. Combined with FDA's clearance from August 2017, this means SyMRI as a whole can now be offered to clinics and hospitals on the US market.
SyMRI NEURO is the next level of quantitative MR. The unique technology measures the absolute tissue properties of the brain and provides quantitative data, automatic segmentation and adjustable contrast images. This provides more information to the clinician and offers objective decision support for diagnosis and follow-up of the patient.
SyMRI NEURO is also the first product on the market that includes measurements and segmentation of myelin volymes. Quantification of myelin may be useful to monitor patients with neurodegenerative disorders such as multiple sclerosis and dementia.
"FDA's message is a milestone in the history of SyntheticMR," says Stefan Tell, CEO SyntheticMR. "The clearance means we can now establish our entire product package on the US market and offer clinicians objective decision support for a faster and more reliable diagnosis of their patients. A number of studies published this past year show the clinical benefits of SyMRI NEURO. One large study showed normalized curves of brain tissue in children that in the future may be used for a faster diagnosis within pediatrics. We are convinced that this is the beginning of a paradigm shift within MRI," continues Stefan Tell.
Initially the clearance is attached to MR cameras from GE Healthcare.
For further information, please contact Fredrik Jeppsson, CFO and Head of Investor Relations SyntheticMR AB, +46 72 303 13 39 or Stefan Tell, CEO SyntheticMR AB, +46 73 373 40 90.
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 5-6-minute scan – generating increased patient throughput and objective decision support for clinicians. SyMRI is CE-marked and FDA 510(k) cleared. 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
This information is information that SyntheticMR AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on January 29 2018.