FDA clears ViewRay's next-generation MRIdian Linac system

ViewRay on Monday announced that it received 510(k) clearance from the FDA to market its MRIdian Linac next-generation, linear accelerator-based, MRI-guided radiation therapy system. CEO Chris Raanes said "we believe that availability of the world's first commercial system to combine MRI for soft-tissue visualisation and a compact linear accelerator will lead to a new standard of care in radiation oncology." 

Raanes explained that clinical experience with the first-generation system "demonstrated the benefits of on-table adaptive therapy and real-time MRI guidance, as clinicians are seeing for the first time how much tumours and organs move and change shape during the course of treatment."

The company said the first two systems in the US will be installed at Henry Ford Hospital in Michigan and Barnes-Jewish Hospital in Missouri.

The MRIdian Linac system was awarded CE mark approval in Europe last September. ViewRay noted that it received four new orders for MRIdian systems in the fourth quarter of 2016 totalling $24.3 million, as well as 13 new orders worth $77 million in the full year. 

Did you like this article?