SyntheticMR has gained FDA clearance for its software SyMRI®.
The regulatory clearance by the US Food and Drug Administration, FDA, relates to the product package SyMRI IMAGE. The clearance means SyMRI IMAGE can be offered to new customer segments at hospitals and clinics on the US market for added efficiency in MRI and to facilitate diagnostic decisions.“The U.S. market alone is the largest MRI market globally. This FDA clearance is an important first step toward establishing SyMRI on this market. A natural next step is that we will now expand our marketing efforts in the US. We will also proceed with an application for regulatory FDA clearance for