SyntheticMR has gained further clearance from FDA for its software SyMRI®
The new regulatory clearance from the American Food and Drug Administration, FDA, concerns the SyMRI IMAGE and NEURO product packages. The clearance concerns the clinical use of SyMRI together with Philips MR scanners.
SyMRI IMAGE is designed to optimize workflow and shorten the exam time using synthetic MRI, which results in up to 8 contrast images through an exam of approximately 5 minutes.
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.
“The approval represents growth on our accessible market in the US, which is the world’s largest market. We now have the opportunity to sell our product to customers with MR systems from two of the world’s largest manufacturers on this market. Now the fact that we can offer our products to customers who have Philips MR scanners is an important step in the continued global establishment of our product, “says Stefan Tell, CEO SyntheticMR AB.
SyMRI is now cleared by the FDA for clinical use together with MR scanners from Philips and 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 Spotlight Stock Market 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 June 12, 2018.