Radiation oncology vendor Elekta has received 510(k) premarket approval from the U.S. Food and Drug Administration (FDA) for its Elekta Unity MR radiation therapy system for sale and clinical use in the U.S.
Unity is designed to treat cancer by delivering a radiation dose while simultaneously visualizing the tumor and surrounding healthy tissue with MRI. Unity also integrates advanced tools for clinicians to adapt the patient's treatment based on up-to-date anatomical information within the treatment session.
Elekta Unity received the CE Mark in June 2018 for commercial marketing and clinical use in Europe.
