FDA approves diffusion-weighted images for Elekta Unity, expanding options for assessment during therapy
Elekta Unity MR-Linac cleared for diffusion-weighted images to assess tumor response paving the way toward a new era of personalized radiotherapySTOCKHOLM, December 16, 2019 – Elekta (EKTA-B.ST) today announced that it has received 510(k) premarket notification from the U.S. Food and Drug Administration for the use of diffusion-weighted MR images (DWI) obtained with Elekta Unity to be interpreted by a trained physician. This expands the clinical utility of Elekta Unity to include biologic assessment of tumor response during therapy, allowing treatment adaptation based not just on gross