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

FDA Clears Advancements for Viewray MRIdian Radiation Therapy System
Technology | Image Guided Radiation Therapy (IGRT) | February 21, 2019
February 21, 2019 — ViewRay Inc. received 510(k) clearance from the U.S.
Videos | Radiation Therapy | February 20, 2019
ITN Associate Editor Jeff Zagoudis speaks with Vinai Gondi, M.D., director of research and CNS neuro-oncology at the
Joseph J. Cappello Named Executive Director of Are You Dense Nonprofits
News | Breast Density | February 20, 2019
The boards of Are You Dense Inc. and Are You Dense Advocacy Inc., founded by the late Nancy M. Cappello, Ph.D.,...
Study Unveils Blueprint for Treating Radiation-Resistant Brain Tumor

NIH-funded researchers showed how gliomas may be treated with radiation and drugs that block DNA repair. Image courtesy of Castro lab, Michigan Medicine, Ann Arbor

 

News | Radiation Therapy | February 19, 2019
February 19, 2019 — Researchers at the University of Michigan recently searched for new brain tumor treatments by exp
Congress Directs FDA to Establish Federal Breast Density Inform Standard
News | Breast Density | February 19, 2019 | Jeff Zagoudis, Associate Editor
As part of a federal spending bill passed late Friday, Congress directed the U.S. Food and Drug Administration (FDA) to...
Videos | Radiation Therapy | February 15, 2019
ITN Associate Editor Jeff Zagoudis speaks with Vinai Gondi, M.D., director of research and CNS neuro-oncology at the
New Targeted Therapy for Recurrent Brain Tumors Implanted for First Time
News | Radiation Therapy | February 15, 2019
University of Minnesota Health (M Health) is the first in the United States to begin offering GammaTile Therapy, a new...
Densitas Enters Partnership Agreement With TeleMammography Specialists
News | Breast Density | February 14, 2019
Breast imaging analytics company Densitas Inc. announced a new collaboration partnership with TeleMammography...
Hologic Launches Unifi Analytics Business Intelligence Tool
Technology | Analytics Software | February 12, 2019
Hologic Inc. announced the U.S. launch of Unifi Analytics, a business intelligence tool that allows healthcare...
Mount Sinai's Digital 3-D Mammography Van Rolls Into New York City
News | Mammography | February 11, 2019
Mount Sinai Hospital recently launched the Mount Sinai Mobile Mammography Program (MMP), bringing essential breast...