FDA greenlights SyMRI NEURO software

February 01, 2018
by John R. Fischer, Senior Reporter
SyntheticMR AB’s software, SyMRI, will soon be available in its entirety to U.S. consumers, following FDA clearance of its SyMRI NEURO product package.

The thumbs up from the FDA follows its clearance in August of SyMRI Image, another software package, and marks the introduction of SyMRI NEURO as the first product on the market for measuring and offering segmentation of myelin volumes, the amount of which can be used as a monitor for people with neurodegenerative disorders, such as dementia and multiple sclerosis.

“SyMRI NEURO measures the absolute tissue properties in the brain and presents myelin volumes per slice, and per region of interest defined by the clinician,” Jonas Hurtig, chief commercial officer of SyntheticMR AB, told HCB News. “This data can be followed and compared over time, so the clinician can base their decisions on real numbers rather than subjective assessment. It is a great complement to those of our clients who would like more information at the workstation for the same scan time of about 6 minutes.”

SyMRI NEURO measures the absolute tissue properties of the brain, offering quantitative data, automatic segmentation and adjustable contrast images to assist physicians in making objective decisions regarding diagnoses and follow-ups.

Clearance for the product is supported by a number of studies conducted over the past year that show its clinical benefits, including a large one that found normalized curves of brain tissue in children, potentially indicating the use of SyMRI NEURO for making diagnoses faster in pediatric patients in the future.

“Our way of quantifying absolute tissue properties is unique, and we are convinced we can lead the transition to quantitative MR and establish SyMRI as the gold standard of MR imaging,” Hurtig said. “SyMRI NEURO is the first product to utilize this unique capability to present segmentations, volumes and quantitative data of the patient.”

The clearance is initially attached to MR cameras from GE Healthcare, with sales expected to begin at the end of this quarter.

SyMRI is also CE marked.