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Elekta Secures FDA 510(k) Clearance for Advanced Radiotherapy Motion Management Using Elekta Unity MR-Linac


Elekta has announced that Comprehensive Motion Management (CMM) with True Tracking and automatic gating for its Elekta Unity MR-Linac has received U.S. FDA 510(k) clearance. True Tracking represents a milestone in the history of radiotherapy. For the first time in the U.S., Elekta Unity can continuously calculate the movement of the tumor anywhere in the body and account for it automatically. This functionality will allow clinicians to utilize the enhanced adaptive radiation therapy workflow to deal with moving organs and treat patients more accurately.
CMM supports four workflows that allow the user to manage the treatment of targets that are either subject to periodic breathing motion or random movements. These include two free breathing workflows that avoid the need for the patient to hold their breath which can be challenging. The precision of the management of breathing motion is enhanced by integrated predictive algorithms which compensate for any system delays.
CMM also allows clinicians to rapidly shift the beam to account for systematic changes in target position that might occur during the treatment session without re-imaging, which helps to save time. Together, this comprehensive offering helps clinicians tailor their motion management strategy to the specific needs of their patients. CMM makes Elekta Unity the most advanced MR-Linac with diagnostic-quality imaging on the market and heralds a new era in precision radiation therapy.
“Improving the accuracy of beam delivery is the key to increasing the therapeutic window in radiotherapy,” said Dr. Lorraine Portelance, Vice Chair of Radiation Oncology at the University of Miami. “But of course, to truly improve accuracy we have to both track the motion and be able to quickly respond to it. These new motion management features do that and was a big reason we have decided to invest in this system.”
Carlos Castilleja, Executive Vice President of Region Americas said: “We have the privilege to be working in radiotherapy, a field that helps people at their most vulnerable moment in life. To know that we can now bring a technology to the U.S. that really moves the needle in cancer care gives me and my whole team great satisfaction. We believe MR-guided therapy is going to play a major role in radiotherapy moving forward. This is evidenced by a large hospital network in New Jersey that is in the process of setting up three Elekta Unity systems, in addition to the more than 100 systems ordered or in use in the U.S. and around the world. We must also acknowledge the amazing scientists and engineers who made this extraordinary innovation possible.”
CMM enables increased precision with no additional set-up time for the user, no hardware to install and no major changes to standard radiotherapy processes.

*Elekta Unity with Comprehensive Motion Management (CMM) has FDA 510(k) clearance and is CE marked, with limited global availability.
Source: Elekta

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