3D MRI for Quantitative Brain Imaging Gets FDA Nod

The Food and Drug Administration (FDA) has granted 510(k) clearance for SyMRI 3D, a modality that may offer enhanced resolution and accuracy for brain magnetic resonance imaging (MRI) scans.

Combining quantitative MRI technology with isotropic resolution, SyMRI 3D provides improved accuracy in brain lesion analysis and facilitates brain structure and function assessments through precise brain region volume estimates, according to SyntheticMR U.S., the developer of the SyMRI 3D modality.

“Receiving 510(k) clearance for SyMRI 3D allows us to empower physicians to make more precise and informed decisions in diagnosis and treatment planning through quantitative imaging," said Jared Dixon, the president of SyntheticMR U.S.

SyMRI 3D will also be available to Philips customers as per a recently expanded partnership agreement between the two companies that was announced in November 2023.