Sweden-based company SyntheticMR has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SyMRI 3D software.
SyMRI 3D offers quantitative MRI capability for MRI brain imaging. The software enables volumetric estimations of brain regions, a technique commonly referred to as parcellation, which can provide clinicians insights into brain structure and function. Furthermore, the resolution provided by SyMRI 3D facilitates comprehensive lesion analysis, the company said.