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.