Research & Development
Elekta announces receipt of FDA 510(k) clearance in US by Elekta Unity
6 December 2018 -

Human care company Elekta AB (STO:EKTAB.ST) announced on Wednesday the receipt by its Elekta Unity magnetic resonance radiation therapy (MR/RT) system of 510(k) premarket notification from the US Food and Drug Administration, clearing the technology for commercial sales and clinical use in the US.

Reportedly, Elekta Unity had received CE mark in June 2018 and has been transforming the care of cancer patients in Europe.

According to the company, with Elekta Unity, it is now feasible to develop personalised, precision radiation therapy regimens that are optimised for safety and efficacy and make radiation therapy a viable treatment option for more patients.

Also, Unity has the potential to transform how clinicians treat cancer by enabling the delivery of the radiation dose while simultaneously visualising the tumour 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.

Elekta offers treatment solutions and oncology informatics portfolios that are designed to enhance the delivery of radiation therapy, radiosurgery and brachytherapy, as well as to drive cost efficiency in clinical workflows.

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