SyntheticMR gets FDA 510(k) clearance for MAGiC

11 September 2016 (Last Updated September 11th, 2016 18:30)

Sweden-based SyntheticMR has received 510(k) clearance from the US Food and Drug Administration (FDA) for its multi-contrast magnetic resonance (MR) technique, MAGiC.

Sweden-based SyntheticMR has received 510(k) clearance from the US Food and Drug Administration (FDA) for its multi-contrast magnetic resonance (MR) technique, MAGiC.

Magnetic Resonance Image Compilation (MAGiC) is developed as an acquisition technique to allow clinicians to modify image contrast after completing a scan and allowing them to view multiple different contrasts derived from a single scan.

The changes of the image paves the way for clinicians to improve their diagnosis of ailments.

"This study proves that this technique can improve the way clinicians conduct neuro scans and diagnose their patients."

It also allows the flexibility to change images retrospectively saving time, causing fewer rescans and saving costs.

MAGiC is the integrated and customised variant of SyntheticMR’s SyMRI IMAGE software marketed by GE Healthcare under a license agreement.

SyMRI IMAGE assists in optimising workflows and reduces scan times using synthetic MRI. Its tools enable fast and easy viewing, as well as handling of images.

SyntheticMR’s partner GE Healthcare undertook a blinded, mulit-centre, multi-reader clinical study to compare MAGiC to conventional MRI, which suggested comparable results of the image quality of MAGiC with that of the conventional images at a fraction of the scan time.

GE Healthcare MR president and CEO Eric Stahre said: “This study proves that this technique can improve the way clinicians conduct neuro scans and diagnose their patients.

“Neuro scans are approximately 30% of all MR scans; therefore MAGiC could have a tremendous impact on the MR community.