SyntheticMR Gains Regulatory Clearance for SyMRI 3D in Japan

SyntheticMR, a global leader in quantitative imaging software, announced that its SyMRI 15 (3D) solution has received regulatory clearance in Japan. This approval permits the distribution of SyMRI 3D across Japan and will enhance SyntheticMR’s strong market position and benefit healthcare providers in the region.

This strategic move is aligned with SyntheticMR’s recent acquisition of Combinostics. The release of SyMRI 3D is the first step in the combination of SyntheticMR’s ability to provide brain tissue characterization with Combinostics’ segmentation algorithms, offering unique insights into automatically parcellated brain structures and segmented lesions, particularly related to neurodegenerative diseases such as MS and dementia.

SyMRI 3D provides high-resolution, rich quantitative data in 3D, including quantitative values, accurate segmentation, and adjustable contrasts. A prospective, multi-center, multi-reader clinical investigation to evaluate the diagnostic performance of SyMRI 3D images to conventional 3D MRI has shown the capability to replace conventional 3D imaging.

“The regulatory approval in Japan serves as solid confirmation of our established track record and underscores our commitment to deepening our engagement with the healthcare community in the region,” stated Johanna Norén, Acting CEO of SyntheticMR.