Brachytherapy device developer Xoft of Sunnyvale, CA, has been granted a medical device license by the Medical Devices Bureau of Health Canada to sell its Axxent electronic brachytherapy system, the company said. It has also won certification from the International Organization for Standardization (ISO) for the design, development, and manufacture of Axxent and its components.
Axxent has been commercially available in the U.S. since 2006 for treatment of early-stage breast cancer, endometrial cancer, and skin and surface indications. It has also been approved by the U.S. Food and Drug Administration (FDA) for use in the treatment of other cancers or conditions where radiation therapy is indicated, Xoft said.
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FDA clears Xoft treatment applicator, March 5, 2009
Xoft's Axxent used in IORT procedure, October 1, 2008
Rhode Island Hospital uses Axxent for endometrial cancer, September 29, 2008
Xoft debuts mobile brachytherapy vehicles, September 18, 2008
Xoft launches electronic brachytherapy registry, June 26, 2008
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