FDA clears Xcision Medical’s GammaPod breast cancer device

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.

GammaPod is not intended to replace whole-breast radiation therapy and has not been shown to be as effective as that technique, the FDA said. The clearance was based on a 17-patient study testing its ability to accurately deliver radiation while minimizing side effects in healthy tissue, such as skin redness or erythema.

“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,” radiological health acting deputy director Robert Ochs, of the Office of In Vitro Diagnostics & Radiological Health, said in prepared remarks.

Xcision was founded in 2006 by CEO Cedric Yu of the University of Maryland School of Medicine in Baltimore, who in 1993 invented intensity-modulated arc therapy, now known as VMAT, according to the company’s website.

The post FDA clears Xcision Medical’s GammaPod breast cancer device appeared first on MassDevice.

from MassDevice http://ift.tt/2kGJbeB