FDA gives 510(k) approval for GammaPod radiation treatment for breast cancer.- Xcision Medical Systems.

The FDA has given 510(k) clearance for GammaPod, from Xcision Medical Systems, a new noninvasive stereotactic radiotherapy system intended for use in treating cancer in breast tissue. The FDA reviewed scientific evidence including a clinical study of 17 patients that tested the feasibility of accurately delivering the prescribed dose to the breast tumor while minimizing radiation to the healthy tissue. The clinical evidence supports delivering the prescribed dose to the breast tumor with minimal radiation-induced side effects such as skin redness or erythema.

The GammaPod system is intended for use in the noninvasive stereotactic delivery of a radiation dose to a portion (partial volume) of the breast in conjunction with breast conserving treatment. During the procedure, radiation is delivered to specific areas of the breast. The GammaPod has not been shown to be as effective as whole breast radiation therapy (WBRT) and is not intended to replace WBRT.