SyntheticMR announced today that its next-generation 3D imaging solution with isotropic resolution received FDA 510(k) clearance.
Linköping, Sweden-based SyntheticMR said in a news release that the regulatory nod “marks a significant advancement in quantitative MRI technology.” The company says its SyMRI 3D offering provides “unprecedented resolution and accuracy in brain imaging.”
Related: Endostart bags FDA 510(k) clearance for its magnetic colonoscopy device
Approval marks the second major milestone for SyntheticMR in the past month. The company recently entered into a collaboration with Dutch medtech giant Philips to support its technology for brain disorder diagnosis and therapy.
“We are thrilled to receive 510(k) clearance for SyMRI 3D,” said Ulrik Harrysson, CEO at SyntheticMR. “SyMRI 3D represents the next generation of quantitative MRI, revolutionizing the landscape of medical diagnostics and offering new possibilities for diagnosis and treatment.”
SyMRI 3D enables precise volumetric estimations of brain regions through a technique called parcellation. This allows clinicians to gain deeper insights into brain structure and function. It also facilitates comprehensive lesion analysis, ensuring a more accurate and in-depth assessment of medical conditions.
SyntheticMR says its FDA clearance reaffirms the company’s commitment to advancing medical imaging and offering innovative tools. It said SyMRI 3D opens up new possibilities for precise diagnosis, treatment planning and monitoring.
“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,” says Jared Dixon, president of SyntheticMR U.S.
