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Elekta's Unity

Elekta Unity MR-linac gains FDA 510(k) clearance

by Thomas Dworetzky , Contributing Reporter
The Elekta Unity magnetic resonance radiation therapy (MR/RT) system has gotten its FDA 510(k) premarket notification and is now ready for sale and clinical use in the U.S.

“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,” Elekta president and CEO Richard Hausmann said in a statement, adding that the Unity will make possible the development of personalized, precision radiation therapy regimens optimized for safety and efficacy.

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The Unity will “make radiation therapy a viable treatment option for more patients,” he added, thanking all involved in the MR-linac consortium and MR technology partner, Royal Philips.

The Unity is designed to simultaneously deliver radiation dose and visualization of tumors and adjacent healthy tissue in the form of high-quality MR images, employing integrated tools for possible treatment adjustments to match current anatomical information in 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 Dr. Christopher Schultz, chair of the Elekta MR-linac Consortium.

He called the new technology “fundamentally” transformational in terms of the development and implementation of therapy regimens that will permit clinicians “to achieve optimal outcomes for our patients.”

Back in September, Elekta forecast a net sales compound annual growth rate of 8-10 percent through its 2022/2023 financial year.

“We have improved our margin and cash flow and have returned to high growth. We are now in a good position to realize our vision,” said Hausmann in a statement, noting that “the future of our industry is in precision radiation medicine, including diagnostic quality imaging at the point of treatment, real-time adaptive treatment planning, data-driven personalization and intelligent automation.”

Its predictions follow the company's recent decision to sell its magnetoencephalography (MEG) business to Croton Healthcare subsidiary York Instruments as part of an initiative to restructure and strategically prioritize its treatment solutions and oncology informatics portfolio, agreements set up between the radiotherapy manufacturer and other parties over the past year.
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