The FDA said today that it granted 510(k) clearance to the GammaPod stereotactic radiotherapy device made by Xcision Medical Systems to treat breast cancer.
The federal safety watchdog said the GammaPod is designed to treat a portion of the breast in conjunction with breast-conserving surgery. It uses an array of 36 Cobalt-60 sources to beam radiation from within a two-layer vacuum cup that immobilizes the breast to minimize damage to adjacent healthy tissue.
