SyntheticMR Wins FDA Nod for SyMRI 15 Solution

SyntheticMR, a developer of quantitative imaging software, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its SyMRI 15 solution on diagnostic image replacement of conventional images.

SyMRI 15 transforms traditional imaging methodologies with its advanced synthetic imaging technology. It’s been clinically validated in extensive multi-center studies across leading U.S. institutions, according to the company.

The technology has proven its ability to enhance imaging workflows by replacing conventional 3D imaging techniques and provide tissue quantification. SyntheticMR says it offers significant improvements in efficiency and throughout, while maintaining high diagnostic accuracy standards.

The SyMRI product delivers multiple, adjustable contrast images and quantitative data from a single, five-minute scan. The 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 are CE-marked.

Last week, SyntheticMR began a deal to acquire all shares of Finnish company Combinostics Oy (Combinostics), a leading player in medical technology and software solutions, focusing on cloud-based and AI-driven platforms that offer advanced diagnostic tools and clinical decision support for healthcare providers.