SyMRI software (Courtesy: SyntheticMR)

FDA approves sale of SyMRI IMAGE software for GE Healthcare MR scanners

September 11, 2017
by John Fischer, Staff Reporter
SyntheticMR’s software, SyMRI IMAGE, is now available in GE Healthcare's MR scanners, following FDA-approval.

The product is licensed to GE Healthcare under the brand name, MAGiC (MAGnetic resonance image Compilation) and is designed to ensure shorter scan times while offering insights to determine diagnostic decisions.

“The synthetic MR imaging quality is diagnostically non-inferior to conventional imaging, with the added value of reduced exam times,” Jonas Hurtig, a spokesperson for SyntheticMR, told HCB News. “We have a unique value proposition and do not face any direct competition in the marketplace.”

SyMRI IMAGE can reconstruct a variety of image contrasts from one scan, thereby reducing overall scanning time, saving providers big costs and eliminating the need for patients to return for further scans.

Approval for the software was based on the results of the MAGiC study in the American Journal of Neuroradiology, the first to compare synthetic and conventional MR imaging in the assessment of neurological conditions.

Seven blinded neuroradiologists read through 1,526 imaging case-control pairs from 109 subjects with neuroimaging indications, acquired through synthetic and conventional brain MR scans. Clinical MR imaging studies found 46 healthy and 63 pathologic cases. Participants were between the ages of 19 and 89. The study found that the quality of synthetic MR imaging showed similarities to that of conventional proton density, Short-TI Inversion Recovery (STIR) and T1- and T2-weighted contrast views regarding neurological conditions.

Hurtig says that SyMRI IMAGE has potential to become a common tool for assessing neurological conditions.

“We are convinced that our way of quantifying brain tissue will revolutionize the MR software market, and that our solution will become the standard method for following up on patients with neurodegenerative brain disorders,” he said.

SyntheticMR previously partnered with Siemens Healthineers last year to make SyMRI software packages compatible with its MR scanners, starting in 2017.

The software is CE-marked. It is approved for use in Singapore, Australia and New Zealand under Philips, and in Japan under Sectra and Philips.