News | Brachytherapy Systems, Women's Healthcare | August 30, 2017

China FDA Approves Xoft Axxent Balloon Applicators for Early-Stage Breast Cancer

Approval finalizes availability of complete suite of Xoft System products in China

China FDA Approves Xoft Axxent Balloon Applicators for Early-Stage Breast Cancer

August 30, 2017 — iCAD Inc. announced that the company’s Xoft Axxent balloon applicators have received approval from the China Food & Drug Administration (CFDA) for the treatment of early-stage breast cancer. 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.

With this CFDA approval, the complete suite of Xoft System products is now available to clinicians and patients in China.

IORT with the Xoft System allows radiation oncologists and breast surgeons to work together to deliver a full course of radiation to the tumor site at the time of lumpectomy. The balloon applicator is used to deliver a single, precise dose of radiation to the lumpectomy cavity, directly targeting cancer cells while minimizing exposure to healthy surrounding tissue. In the procedure, the Xoft System’s miniaturized X-ray source is inserted into the balloon applicator, providing a channel to deliver high-dose rate, low-energy radiation treatment. The balloon applicator is available in multiple sizes and shapes, can be filled with different volumes of saline to best fit the contour of the surgical cavity, and allows delivery of a more conformal radiation dose.

“The Xoft Axxent balloon applicators offer an attractive option for physicians and patients who desire improved flexibility, precision and personalization in the targeted treatment of early-stage breast cancer,” said Liu Yu, COO of Chindex Medical Limited, the distributor of iCAD’s Xoft System in China. “We are pleased to continue working with iCAD in offering our customers access to the most advanced cancer treatments, including the complete portfolio of Xoft System products, in the years ahead.”

The Xoft System is U.S. Food and Drug Administration (FDA)-cleared for the treatment of cancer anywhere in the body, including early-stage breast cancer, non-melanoma skin cancer and gynecological cancers.

For more information: www.xoftinc.com

Related Content

Videos | Mammography | December 10, 2018
Stamatia Destounis, M.D., FACR, associate professor, University of Rochester School of Medicine, and attending radiol
RaySearch Developing RayCommand Treatment Control System for U.K. Proton Therapy Facility
Technology | Radiation Therapy | December 10, 2018
RaySearch has decided to develop a treatment control system, RayCommand, to act as a link between its RayStation...
FDA Clears iCAD's ProFound AI for Digital Breast Tomosynthesis
Technology | Mammography | December 07, 2018
iCAD Inc. announced clearance by the U.S. Food and Drug Administration (FDA) for their latest, deep-learning, cancer...
Fujifilm Collaborates With Lunit on AI Pilot Project
News | Artificial Intelligence | December 05, 2018
Fujifilm Medical Systems USA Inc. announced a joint collaboration with Korean-based medical artificial intelligence (AI...
Mirada Medical Joins U.K. Consortium Exploring Healthcare AI
News | Artificial Intelligence | December 04, 2018
Mirada Medical, a leading global brand in medical imaging software, will form part of an artificial intelligence (AI)...
ScreenPoint Medical and Volpara Partner to Bring AI to Breast Imaging Clinics
News | Computer-Aided Detection Software | December 04, 2018
ScreenPoint Medical has signed a memorandum of understanding (MOU) with Volpara Health Technologies. Volpara will...
GE Healthcare Introduces Invenia ABUS 2.0
Technology | Ultrasound Women's Health | December 03, 2018
GE Healthcare recently launched the Invenia automated breast ultrasound (ABUS) 2.0 system in the United States. This...
Sponsored Content | Videos | Radiation Oncology | November 30, 2018
Accuray's philosophy is to personalize treatments to exactly fit the patient.
Snoring Poses Greater Cardiac Risk to Women
News | Women's Health | November 29, 2018
Obstructive sleep apnea (OSA) and snoring may lead to earlier impairment of cardiac function in women than in men,...