Elekta Unity is pending 510(k) with the FDA for U.S. sales and clinical use clearance
STOCKHOLM, August 7, 2018 – Elekta (EKTA-B.ST) announced today that it submitted a 510(k) application for its Elekta Unity magnetic resonance radiation therapy (MR/RT) system to the U.S. FDA, where the submission is in the review process. Upon receiving FDA 510(k) pre-market clearance, U.S. healthcare providers will then be able to offer Unity’s distinctive real time imaging, planning, and treatment technology to their patients.
Elekta Unity, which combines high-field 1.5 Tesla MR imaging, precision radiation therapy and intelligent software, received CE mark in June 2018 and was included on the Australian Register of Therapeutic Goods (ARTG) for regulatory clearance in Australia in July 2018.
To learn more, visit www.elekta.com/Unity.
Elekta Unity is pending 510(k) pre-market clearance and not available for commercial distribution or sale in the U.S.
This is information that Elekta AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication at 15:15 CET on August 7, 2018. (REGMAR)
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For further information, please contact:
Oskar Bosson, Global EVP Corporate Communications and Investor Relations
Tel: +46 70 410 7180, e-mail: Oskar.Bosson@elekta.com
Time zone: CET: Central European Time
Raven Canzeri, Global Public Relations Manager
Tel: +1 770 670 2524, e-mail: raven.canzeri@elekta.com
Time zone: EST: Eastern Standard Time
About Elekta
Elekta is proud to be the leading innovator of equipment and software used to improve, prolong and save the lives of people with cancer and brain disorders. Our advanced, effective solutions are created in collaboration with customers, and more than 6,000 hospitals worldwide rely on Elekta technology. Our treatment solutions and oncology informatics portfolios are designed to enhance the delivery of radiation therapy, radiosurgery and brachytherapy, and to drive cost efficiency in clinical workflows. Elekta employs 3,600 people around the world. Headquartered in Stockholm, Sweden, Elekta is listed on NASDAQ Stockholm. www.elekta.com
About Elekta Unity
Unity employs a premium high-field diagnostic-quality (1.5T) MRI that provides exceptional image clarity, providing clinicians greater flexibility in their approach to radiation therapy with the hope to allow each patient to receive optimal care based on individual tumor characteristics. Unity integrates MR imaging, linear accelerator technologies and advanced treatment planning into a single platform, allowing clinicians to see and track difficult-to-visualize soft tissue anatomies while radiation dose is being delivered. Unity aims to address an unmet need in cancer therapy, potentially enabling clinicians to see and track the target during treatment and respond accordingly, personalizing therapy for each patient every time they are treated.
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