Radiation oncology vendor Elekta has received 510(k) premarket notification from the U.S. Food and Drug Administration (FDA) for the clinical use of a diffusion-weighted imaging (DWI) MRI protocol with the company's Unity MR radiation therapy system.
The combination of a 1.5-tesla MRI scanner and a 7-MV linear accelerator allows Unity to deliver radiation dose to cancer patients with real-time MR image guidance while also enabling clinicians to adjust dose based on daily anatomical changes. The approval of DWI with Unity expands its clinical utility, allowing clinicians to use information about an individual's tumor response based on DWI to further personalize radiation therapy treatment, Elekta said.
Elekta Unity was initially cleared by the FDA in December 2018 and received the CE Mark in June 2018.
