SyntheticMR receives FDA clearance for use of SyMRI® on MRI systems from Siemens Healthineers
The new regulatory clearance from the American Food and Drug Administration, FDA, relates to the company's product package SyMRI IMAGE and SyMRI NEURO. The clearance means that SyMRI is now also supported for clinical use together with MRI systems from Siemens.
SyMRI IMAGE is designed to optimize workflow and shorten the exam time using synthetic MRI, where up to 8 different contrast images are obtained through an exam of about 6 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.
“SyMRI now has regulatory clearance on the US-market together with all of our partners. This means that our addressable market is further increased since SyMRI can be offered to customers with MRI systems from the world´s three largest manufacturers, GE Healthcare, Philips and Siemens. SyntheticMR has invested in developing our partnerships in recent years and new clearances, like this one from the FDA, shows the results of this work,” says Fredrik Jeppsson, acting CEO of SyntheticMR AB.
SyMRI is now FDA cleared for clinical use with MRI systems from GE Healthcare, Philips and Siemens.
For additional information, please contact Fredrik Jeppsson, acting CEO, SyntheticMR AB, +46 72 303 13 39
SyntheticMR AB develops and markets innovative software solutions for Magnetic Resonance Imaging (MRI). SyntheticMR AB product SyMRI® delivers multiple contrast images and quantitative data from a single 6-minute scan – to improve 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 14th, 2019