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SyntheticMR's SyMRI 15 Receives FDA 510(k) Clearance for Diagnostic Image Replacement

• SyntheticMR's SyMRI 15 has received FDA 510(k) clearance, enabling its use for diagnostic image replacement of conventional MRI images. • The technology enhances MRI workflows by replacing conventional 3D imaging and providing tissue quantification. • SyMRI 15 has been clinically validated through multi-center studies, demonstrating its ability to improve efficiency and maintain diagnostic accuracy. • The clearance marks a significant advancement in MRI technology, offering gains in throughput while upholding high standards.

SyntheticMR, a company specializing in quantitative imaging software, has announced that its SyMRI 15 solution has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance allows SyMRI 15 to be used for diagnostic image replacement of conventional MRI images, marking a significant advancement in MRI technology.

Enhanced MRI Workflow

SyMRI 15 introduces an innovative approach to MRI by using advanced synthetic imaging technology. It has been clinically validated through extensive multi-center studies across leading institutions in the United States. The technology enhances imaging workflows by replacing conventional 3D imaging techniques and providing unique tissue quantification capabilities. This offers significant gains in both efficiency and throughput, while maintaining high standards of diagnostic accuracy.

Clinical Validation and Impact

The FDA 510(k) clearance underscores the clinical utility and safety of SyMRI 15, paving the way for its broader adoption in clinical settings. The ability to replace conventional 3D imaging and provide tissue quantification positions SyMRI 15 as a valuable tool for healthcare professionals seeking to optimize MRI workflows and improve diagnostic outcomes.
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Reference News

[1]
SyntheticMR receives FDA 510(k) clearance for SyMRI 15 - PR Newswire
prnewswire.com · Dec 6, 2024

SyntheticMR's SyMRI 15 obtains FDA 510(k) clearance for diagnostic image replacement, offering advanced synthetic imagin...

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