2017-08-31

SyntheticMR has gained FDA clearance for its software SyMRI®.

The regulatory clearance by the US Food and Drug Administration, FDA, relates to the product package SyMRI IMAGE. The clearance means SyMRI IMAGE can be offered to new customer segments at hospitals and clinics on the US market for added efficiency in MRI and to facilitate diagnostic decisions.

“The U.S. market alone is the largest MRI market globally. This FDA clearance is an important first step toward establishing SyMRI on this market. A natural next step is that we will now expand our marketing efforts in the US. We will also proceed with an application for regulatory FDA clearance for SyMRI NEURO,” says Stefan Tell, CEO SyntheticMR AB.

The clearance is initially tied to MR scanners from GE Healthcare.

For more 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 August 31 2017.

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SYNTHETICMR AB

Storgatan 11
SE-582 23 Linköping
Sweden

+46 (0) 13 101 650
info@syntheticmr.com

SyMRI® SALES

Sten BergKratz
sten.bergkratz@syntheticmr.com
+46 70 872 12 02

Johan Leblicq
johan.leblicq@syntheticmr.com
+32 460 953 964

CUSTOMER SUPPORT

+46 (0) 13 101 656
support@syntheticmr.com

SOCIAL MEDIA

INVESTOR RELATIONS

Fredrik Jeppsson
fredrik.jeppsson@syntheticmr.com
+46 72 303 13 39

inertek

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 one 5-6 minutes scan. The SyMRI product is available in different packages. 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™, parametric T1, T2 and PD maps of the brain, allowing the investigation to be taken even further. SyMRI is CE-marked product. Parts of SyMRI is 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.