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FDA Approves Stereotactic Radiotherapy System for Breast Cancer

Silas Inman @silasinman
Published: Friday, Dec 22, 2017

The FDA has approved a novel breast-specific stereotactic body radiotherapy (SBRT) device known as GammaPod as a treatment for patients with early breast cancer, based on findings from a 17-patient study.

The device was approved under the 510(k) premarket notification pathway. Xcision Medical Systems developed and will market GammaPod. The company was launched out of the University of Maryland following a .5 million SBIR grant from the National Institutes of Health.
Feigenberg S, Nichols E, Mutaf Y, et al. Initial Clinical Experience with a Noninvasive Breast Stereotactic Radiotherapy Device: the GammaPod. Presented at: 26th ESTRO Congress; May 5-9, 2017; Vienna, Austria. Abstract EP-1183.

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