Elekta high-field MR-linac Unity receives FDA 510(k) clearance

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Elekta has announced that its Elekta Unity magnetic resonance radiation therapy (MR/RT) system has received 510(k) premarket notification from the U.S. Food and Drug Administration, clearing the technology for commercial sales and clinical use in the United States.

“Since receiving CE mark in June 2018, Elekta Unity has been transforming the care of cancer patients in Europe, and we are excited that this cutting-edge technology is now commercially available to U.S. patients,” said Richard Hausmann, President and CEO, Elekta. “With Elekta Unity, it is now feasible to develop personalized, precision radiation therapy regimens that are optimized for safety and efficacy and make radiation therapy a viable treatment option for more patients. We thank our international MR-linac consortium members and our MR technology partner, Philips, as well as our dedicated employees for helping us to achieve this milestone, which is a critical one for Elekta and the patients who may benefit from this cutting-edge technology.”

Unity has the potential to transform how clinicians treat cancer by enabling the delivery of the radiation dose while simultaneously visualizing the tumor and surrounding healthy tissue with high-quality MR images. Unity also integrates advanced tools that allow clinicians to adapt the patient’s treatment to this current anatomical information within a treatment session.

“Unity is a tremendous leap forward in our ability to tailor radiation therapy to each patient’s tumor and anatomy and to adapt treatment in real time as the tumor changes shape and position relative to organs at risk,” said Christopher Schultz, MD, FASTRO FACR, Medical College of Wisconsin, Bernard and Miriam Peck Family Professor and Chairman of the Department of Radiation Oncology, at the Froedtert & MCW Cancer Network and Chair of the Elekta MR-linac Consortium. “I believe this enabling technology will fundamentally transform how radiation therapy regimens are developed, implemented and adapted to achieve optimal outcomes for our patients. We are excited to offer Unity to our patients and are proud of our contributions to making this technology a clinical reality.”

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Elekta high-field MR-linac Unity receives FDA 510(k) clearance.  Appl Rad Oncol. 

By News Release| December 05, 2018
Categories:  Section|Technologies

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