CFDA Update: CFDA has approved iCAD Inc.’s Xoft Axxent balloon applicators for the treatment of early-stage breast cancer. This approval makes the complete suite of Xoft System products available in China. The Xoft Axxent balloon applicators are a key component of the Xoft Axxent Electronic Brachytherapy (eBx) System, which is used to perform intraoperative radiation therapy (IORT) in early-stage breast cancer patients who meet specific selection criteria.
In China, this product, as approved now by CFDA will be distributed by Chindex Medical Limited, the current distributor of iCAD’s Xoft System in China.
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