SyntheticMR receives FDA 510(k) clearance for SyMRI 15

Press releases may be edited for formatting or style | December 10, 2024 MRI

LINKÖPING, Sweden, Dec. 6, 2024 /PRNewswire/ -- 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.

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