Bayer's MR contrast injection system cleared by FDA for expanded use

Bayer’s power MRI contrast injector system has been cleared by the U.S. Food and Drug Administration for expanded indications. 

The MEDRAD MRXperion Magnetic Resonance (MR) Injection System was designed to streamline contrast-related workflows while improving consistent dose delivery. It is a multi-vial system that enables setup of around 20 seconds per patient, significantly reducing workflow hiccups related to loading contrast injectors. 

The updated clearance expands the system's labeled field strength compatibility; the change will allow MRI suites with scanners up to the 7T range to utilize the system. The update also introduces Imaging Scanner Interface 2 (ISI2) capability—a framework that enables communication between the injector and the scanner. 

“MRXperion already has a strong track record of delivering dependable imaging performance across clinical settings, and this clearance reinforces and expands on its established reputation as a flexible solution that supports coordinated, efficient workflows across MR systems,” Vice President and Head of Radiology North America Product & Pipeline at Bayer, Jill Carbone, said in an announcement. “The clearance also exemplifies our continued innovation in MR solutions to consistently meet the needs of today’s imaging providers.” 

The system comes equipped with smart contrast dose management technology to ensure patients receive the optimal amount; this includes settings for measuring the proper dose based on weight and eGFR metrics. What’s more, it also is backed by remote support—a feature that will become increasingly important as more organizations look to expand capacity via remote imaging operations.  

Read more about the expanded approval here.