Sweden-based medical imaging software provider SyntheticMR has received the US Food and Drug Administration (FDA) 510(k) approval for its SyMRI 15 solution.
SyMRI 15 is an advanced imaging solution that extends the company’s SyMRI 3D (14th version) with advanced applications.
The MRI solution provides images that are proven to have the same capability as conventional images for diagnostic use and deliver more value from the same sequence.
According to the company, SyMRI 15 offers a new approach to MRI, advancing traditional imaging methodologies with its advanced synthetic imaging technology.
It is clinically validated in multi-centre studies across top institutions in the US.
In the studies, the MRI solution has enhanced imaging workflows by replacing conventional 3D imaging techniques and its unique ability to provide tissue quantification.
Also, the imaging technology provides significant benefits in efficiency and throughput while maintaining the highest standards of diagnostic accuracy, said SyntheticMR.
The study findings confirm the diagnostic accuracy of SyMRI, providing its users with confidence to replace conventional 3D images with SyMRI T1 and T2 images.
In June this year, SyMRI secured CE mark approval in the European Union (EU), followed by regulatory approvals in the UK, Switzerland, and Australia.
SyntheticMR specialises in developing and marketing advanced MRI solutions that enable synthetic imaging, quantitative tissue analysis, and effective diagnostic workflows.
Listed on the Spotlight Stock Market Exchange in Stockholm, Sweden, the company offers SyMRI in different packages, such as SyMRI NEURO, SyMRI KNEE and SyMRI SPINE.
SyntheticMR has an exclusive agreement with Philips Healthcare to distribute SyMRI 15, where Philips will offer the complete SyMRI package to its customers.
