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Published: 2024-12-06 20:44:00
SyntheticMR, leader in quantitative imaging software, is pleased to announce that its SyMRI 15 solution has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) on diagnostic image replacement of conventional images.
SyMRI 15 offers an innovative approach to MRI, transforming traditional imaging methodologies with its advanced synthetic imaging technology. Clinically validated through extensive multi-center studies across leading institutions in the United States, SyMRI 15 has proven its capability to enhance imaging workflows by replacing conventional 3D imaging techniques in addition to its unique ability to provide tissue quantification. This technology offers significant gains in both efficiency and throughput while maintaining the highest standards of diagnostic accuracy.
For additional information, please contact Vedran Beglerbegovic, acting CEO, SyntheticMR AB, +46 79 077 27 20 vedran.beglerbegovic@syntheticmr.com
About SyMRI: SyMRI provides multiple contrast-weighted images and quantitative information about the patient in a single fast scan, enabling users to speed up their imaging workflow and add objective decision support to their practice.
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 provides 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. For more information, visit www.syntheticmr.com.