November 27, 2023 — SyntheticMR announced that its next-generation imaging solution with isotropic resolution, SyMRI 3D, is FDA-pending for clinical use in the United States.
"We are thrilled to receive 510(k) pending status for SyMRI 3D,” says Ulrik Harrysson, CEO at SyntheticMR AB. “SyMRI 3D represents a pivotal leap forward in medical imaging, offering new possibilities for diagnosis and treatment.”
SyMRI 3D is poised to revolutionize the field of medical imaging by introducing a myriad of innovative applications within SyMRI's post-processing solution. SyMRI 3D enables precise volumetric estimations of brain regions, a technique commonly referred to as parcellation, which empowers clinicians to gain deeper insights into brain structure and function.
Furthermore, the exceptional resolution provided by SyMRI 3D facilitates comprehensive lesion analysis, ensuring a more accurate and in-depth assessment of medical conditions.
"This advanced SyMRI sequence introduces 3D resolution to quantitative values and tissue segmentations, ensuring the same level of precision in quantification as achieved with SyMRI's 2D imaging," says Kyle Frye, CCO & President of SyntheticMR Inc. “Receiving 510(k) clearance for SyMRI 3D will allow us to enable physicians to make better, more informed decisions using quantitative imaging.”
For more information: www.syntheticmr.com
February 20, 2026 
