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Elekta Receives US FDA 510(k) Clearance for Its Monaco 5 Teratment Planning System

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Elekta Inc.
4775 Peachtree Industrial Blvd.
Norcross, GA, 30092
USA



Press release date: November 27, 2013

Monaco 5 radiation therapy treatment planning system unites capabilities in a single system

STOCKHOLM MonacoŽ 5, the latest version of Elekta's Monaco treatment planning system has received 510(k) clearance from the US Food Drug Administration, making it available for purchase and use in the United States.

"Monaco 5 consolidates the best of Elekta's treatment planning solutions into one system, increasing confidence and clinical versatility for the radiation oncology team," says Todd Powell, Executive Vice President of Elekta Software. "Its new system architecture allows advanced treatment plans to be created faster than ever."

Monaco now supports the full spectrum of radiotherapy techniques, including VMAT, IMRT and 3D conformal radiation therapy. The system is especially well equipped for sophisticated stereotactic therapies, such as SRS and SRT, with added planning support for specialized beam shaping solutions, including circular cones. As in all Monaco releases, the new version employs the Monte Carlo dose engine, considered the gold standard for calculating radiation dose.

Clinicians at Union Hospital's HUX Cancer Center (Terre Haute, Indiana) have been evaluating the non-clinical alpha version of Monaco 5 for several months.

"Monaco 5 gives us a single point where all of our planning can be completed, regardless of whether we prepare stereotactic, electron, IMRT, VMAT or 3D plans. From a workflow standpoint it's a huge improvement," says Michele Verst, MS, HUX's chief medical physicist. "In addition, the Monaco 5 user interface is more intuitive than previous versions – everything is nicely organized. For example, if you want to do contouring, you click on the contour tab and all your tools are right there. The icons are a nice size and clearly visible. From usability, workflow and data management perspectives, Monaco 5 gives us tremendous benefits."
Learn more at www.elekta.com/Monaco5.

For further information, please contact:
Michelle Joiner, Director, Global Public Relations and Brand Management, Elekta
Tel: +1 770-670-2447, email: michelle.joiner@elekta.com

The above information is such that Elekta AB (publ) shall make public in accordance with the Securities Market Act and/or the Financial Instruments Trading Act. The information was published at 17:00 CET on November 27, 2013.

About Elekta
Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. The company develops sophisticated, state-of-the-art tools and treatment planning systems for radiation therapy, radiosurgery and brachytherapy, as well as workflow enhancing software systems across the spectrum of cancer care. Stretching the boundaries of science and technology, providing intelligent and resource-efficient solutions that offer confidence to both healthcare providers and patients, Elekta aims to improve, prolong and even save patient lives.

Today, Elekta solutions in oncology and neurosurgery are used in over 6,000 hospitals worldwide. Elekta employs around 3,500 employees globally. The corporate headquarters is located in Stockholm, Sweden, and the company is listed on the Nordic Exchange under the ticker STO:EKTAB. Website: www.elekta.com.

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