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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
controller capability that will support the cervical applicator and offer
enhanced platform features.
About iCAD, Inc.
iCAD is a leading provider of advanced image analysis, workflow solutions and
radiation therapies for the early identification and treatment of common
cancers. iCAD offers a comprehensive range of high-performance, upgradeable
CAD solutions for mammography and advanced image analysis and workflow
solutions for Magnetic Resonance Imaging, for breast and prostate cancers and
Computed Tomography for colorectal cancer. iCAD's Xoft System, offers
radiation treatment for early-stage breast cancer that can be administered in
the form of intraoperative radiation therapy or accelerated partial breast
irradiation. The Xoft System is also cleared for the treatment of non-melanoma
skin cancer and endometrial cancer. For more information, call 877-iCADnow, or
visit www.icadmed.com.
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