STOCKHOLM, Jan. 29, 2018 /PRNewswire/ --
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.
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.
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
This information was brought to you by Cision
http://news.cision.com
http://news.cision.com/syntheticmr-ab/r/segmentation-and-quantification-of-brain-tissue--and-industry-first-myelin-volume-measurements-in-sy,c2439581
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