Bayer has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded capabilities for its Medrad MRXperion MR injection system.
This clearance extends the system's labeled field strength compatibility to MRI scanners up to and including 7 tesla.
The updated clearance also introduces Imaging Scanner Interface 2 (ISI2) capability, which enables communication between the injector and the MRI scanner to support exam coordination and workflow, according to the company.
