iCAD, Inc. (ICAD) said Wednesday that its has received U.S. Food and Drug Administration clearance for its new cervical applicator for use with its Xoft Axxent Electronic Brachytherapy System to deliver high dose rate brachytherapy for intracavitary treatment of cancer of the uterus, cervix, endometrium and vagina.
Xoft's cervical applicator is designed to treat locally advanced stage cervical cancer in combination with the Xoft System by delivering the prescribed radiation dose to the uterus, and cervix, endometrium and vagina with reduced radiation exposure to the surrounding healthy tissue. Brachytherapy is an important component in the curative management of cervical cancer and significantly improves survival.
The Xoft System is a mobile, isotope-free alternative to radionuclide-based high-dose radiation brachytherapy and eliminates several logistical shortcomings associated with isotope, linear accelerator and external beam x-ray based radiation systems.
Xoft also recently received FDA clearance for an upgraded Xoft System controller capability that will support the cervical applicator and offer enhanced platform features.
According to the World Health Organization, cervical cancer is the second most common cancer in women worldwide, with about 500,000 new cases and 250,000 deaths each year.
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