Maryland-based Xcision Medical Systems received 501(k) approval from the FDA for the GammaPod, a new non-invasive breast cancer treatment technology that uses stereotactic radiation therapy to supply a high dose of radiation to a tumor.
Part of the path to FDA clearance included reviewing the results of a clinical study of 17 patients. The GammaPod uses thousands of focused beams of radiation from 36 rotating radioactive sources. In addition, a two-layer, vacuum-assisted cup is meant to immobilize the breast to ensure precise radiation delivery and minimize the negative effects of radiation on healthy tissue.
“With today’s clearance, patients will have access to a treatment option that provides greater accuracy in delivering radiation therapy to breast tumors while saving surrounding breast tissue,” said Robert Ochs, PhD, acting deputy director for radiological health in the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in an announcement.
The FDA notes the GammaPod has not been shown to be as effective as whole breast radiation therapy (WBRT) and is not meant to act as a replacement of WBRT.