Xoft has received clearance from the FDA for a skin and surface treatment applicator for use with the Axxent Electronic Brachytherapy (eBx) system to deliver surface brachytherapy, including intraoperative radiation therapy (IORT).
This latest FDA clearance allows the applicator to be used on any external or internal surface of the body where radiation therapy is indicated, according to the Sunnyvale, Calif.-based company. The Axxent System is also cleared for use in the treatment of surface cancers or conditions where radiation therapy is indicated. The proprietary eBx treatment platform delivers localized, non-radioactive, isotope-free radiation treatment in minimally-shielded clinical settings under the supervision of a radiation oncologist.
In addition to skin indications, Xoft said that the FDA clearance also covers surface indications, which means that IORT procedures can be performed with the Xoft source, while surgery is being performed.