iCAD has received approval from the China Food and Drug Administration (CFDA) for the company's Xoft Axxent balloon applicators for the treatment of early-stage breast cancer.
The Xoft Axxent balloon applicators are part of iCAD's Xoft Axxent electronic brachytherapy system for intraoperative radiation therapy for certain patients with early-stage breast cancer. With this approval, all of iCAD's Xoft products are now available to clinicians and patients in China.
The Xoft system already has clearance from the U.S. Food and Drug Administration (FDA) to treat cancer anywhere in the body, including early-stage breast cancer, nonmelanoma skin cancer, and gynecological cancers.
