SyntheticMR Receives Regulatory Clearance of SyMRI 3D in Japan
SyntheticMR, global leader in quantitative imaging software, is pleased to announce that its cutting-edge SyMRI 15 (3D) solution has received regulatory clearance in Japan. This approval permits distribution of SyMRI 3D across Japan and will enhance SyntheticMR's strong market position and benefit healthcare providers in the region.
SyMRI 3D is designed to improve diagnostic outcomes by providing 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, improving both efficiency and throughput.
This strategically important move is aligned with SyntheticMR’s recent acquisition of Combinostics and is expected to create synergies. The release of SyMRI 3D is the first step in the process enabling 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.
"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.
This regulatory milestone underscores SyntheticMR's dedication to the Japanese market and is expected to drive continued growth and increased adoption of our innovative solutions.
For additional information, please contact Johanna Noren, acting CEO, SyntheticMR AB, +46 70 619 21 00
About SyntheticMR: SyntheticMR AB develops and markets innovative software solutions for Magnetic Resonance Imaging (MRI). SyntheticMR AB has developed SyMRI®, delivering multiple, adjustable contrast images and quantitative data from a single 5-minute scan. The SyMRI product is available in different packages. SyMRI NEURO delivers multiple contrast images, tissue segmentations and quantitative data on the brain. SyMRI KNEE and SyMRI SPINE provide multiple contrast images and quantitative data for knee and spine anatomies. SyMRI NEURO is CE-marked and FDA 510(k) cleared and SyMRI KNEE and SyMRI SPINE is CE-marked. SyMRI is a registered trademark in Europe and the USA. SyntheticMR is listed on the Spotlight Stock Market Exchange in Stockholm, Sweden.
About Combinostics : Combinostics’ AI-powered cNeuro suite of products helps clinicians make a difference in the lives of patients with neurological disorders. By quantifying brain images and integrating patient data from multiple sources with insights from previous patients, the company’s unique software tools provide radiologists and clinicians the support they need for confident, evidence-based diagnostic and management decisions. The company was founded in 2014 and is headquartered in Tampere, Finland and was acquired by SyntheticMR AB in January 2025. For more information, please visit www.combinostics.com