FDA Clears iCAD’s Cervical Applicator For Xoft Electronic Brachytherapy System

In short

iCAD, Inc., a leading provider of advanced imaging and radiation therapy technologies for the detection and treatment of cancer, has announced that the company received U.S. 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.

Background

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.

iCAD provides advanced image analysis, workflow solutions and radiation therapies for the early identification and treatment of common cancers. Its 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.

Now iCAD says the regulatory clearance of Xoft’s cervical applicator will help address an unmet need for improved cervical cancer treatment on a global level.

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.

 Company comments

“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.

Source: iCAD, Inc. Business Wire