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iCAD, Inc. Message Board

  • johnvleb johnvleb Mar 20, 2013 9:56 PM Flag

    Cervival FDA Approval

    iCAD ANNOUNCES FDA CLEARANCE OF CERVICAL APPLICATOR FOR XOFT ELECTRONIC BRACHYTHERAPY SYSTEM
    NASHUA, NH - March 20, 2013 -iCAD, Inc. (Nasdaq: ICAD), a leading provider of advanced imaging and radiation therapy technologies for the detection and treatment of cancer, today announced that the company received U.S. Food and Drug Administration (FDA) 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.
    The regulatory clearance of Xoft's cervical applicator will help address an unmet need for improved cervical cancer treatment on a global level. 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.
    "The addition of the cervical applicator broadens our gynecological product offering to provide treatment for patients with cervical or endometrial cancers. This regulatory clearance further demonstrates the advantages of the Xoft System platform which is also being used today in the treatment of certain breast and skin cancers," said Ken Ferry, iCAD's CEO.
    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 (HDR) 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 contro

 
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