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FDA approves Elekta’s Leksell Gamma Knife Icon radiosurgery system

The US Food and Drug Administration (FDA) has granted 510(k) approval for Elekta’s Leksell Gamma Knife Icon radiosurgery system.

With its stereotactic imaging, online Adaptive DoseControl, ultra-precise dose delivery and frameless treatments options, the Icon can be used to treat virtually any target in the brain, regardless of type, location or volume.

Elekta North America region executive vice-president Bill Yaeger said: "Leksell Gamma Knife Icon offers a new model for the application of precise radiosurgery for a virtually unlimited range of cranial cases.

"Importantly, Icon is the only system with the accuracy to enable ultra-precise Microradiosurgery in cases that demand the utmost precision."

Elekta also received CE mark approval for Gamma Knife Icon in June this year. It was installed at the University Hospital La Timone in Marseilles of France.

According to the firm, Gamma Knife radiosurgery is an alternative to traditional brain surgery for illnesses such as metastatic disease.

Elekta develops and markets tools and treatment planning systems for radiation therapy, radiosurgery and brachytherapy, as well as workflow enhancing software systems for cancer care.