Navigation Links
FDA Approves First 3-D Mammography Imaging System
Date:2/11/2011

SILVER SPRING, Md., Feb. 11, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis.

(Logo:  http://photos.prnewswire.com/prnh/20090824/FDALOGO)

A mammogram is a safe, low-dose X-ray of the breast that is the best tool for early detection of breast cancer. However, with the limitations of conventional two-dimensional (2-D) imaging, about 10 percent of women undergo additional testing after the initial screening exam for abnormalities that are later determined to be noncancerous.

The Selenia Dimensions System, an upgrade to Hologic's existing FDA-approved 2-D system, can provide 2-D and 3-D X-ray images of the breasts. The 3-D images may help physicians more accurately detect and diagnose breast cancer.

"Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health.

The National Cancer Institute recommends women ages 40 and older have a mammogram every one to two years. Nearly 40 million mammograms are performed each year in the United States.

As part of the approval process, the FDA reviewed results from two studies where board-certified radiologists were asked to review 2-D and 3-D images from more than 300 mammography exams.  In both studies, radiologists viewing both the 2-D and 3-D images obtained a 7 percent improvement in their ability to distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone.

While the combination of the Selenia's 2-D and 3-D images approximately doubled the radiation dose the patient received, it improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic workup. There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having both a 2-D and 3-D exam is expected to be less than 1.5 percent compared to the natural cancer incidence, and less than 1 percent compared to the risk from conventional 2-D mammography.

The Mammography Quality Standards Act requires that all health care professionals obtain eight hours of training prior to using new mammography technology on patients. The FDA also requires that the manufacturer provide each facility with a manual clearly defining the tests required for initial, periodic, and yearly quality control measures.

According to the NCI, nearly 200,000 women will be diagnosed with breast cancer this year. And 1 in 8 women will be diagnosed with breast cancer during their lifetime. There is a 98 percent survival rate when breast cancer is detected early and still localized to the breast.

The Selenia Dimensions System is marketed by Bedford, Mass.-based Hologic Inc.

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA




'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves 1st Pacemaker Designed to Work Safely During Some MRI Exams
2. FDA Approves Hologics Makena™ (Formerly Referred to as Gestiva™) Pharmaceutical
3. FDA Approves Drug to Reduce Risk of Preterm Birth in At-Risk Pregnant Women
4. FDA Approves Makena™, the First and Only Treatment to Reduce the Risk of Preterm Birth in Women With a Singleton Pregnancy Who Have a History of Singleton Spontaneous Preterm Birth
5. FDA Approves Viibryd to Treat Major Depressive Disorder
6. FDA Approves Head Lice Treatment for Children and Adults
7. FDA Approves Opioid Analgesic to Help Cancer Patients Manage Pain
8. VIDEO from Endo Pharmaceuticals Available on thenewsmarket.com: FDA Approves New Treatment for Low Testosterone
9. FDA Approves New Dosage Strength for INTELENCE®
10. U.S. FDA Approves Second Bayer Oral Contraceptive That Also Raises Folate Levels
11. FDA Approves PREZISTA®/ritonavir Once-Daily Dosing for HIV-1 Treatment-Experienced Adults With No Darunavir Resistance-Associated Mutations
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... PUNE, India , May 25, 2016 /PRNewswire/ ... Pipeline Review, H1 2016"market research report that provides ... complete with comparative analysis at various stages, therapeutics ... route of administration (RoA) and molecule type, along ... releases. It also reviews key players involved in ...
(Date:5/24/2016)... Cirujanos holandeses han puesto en marcha una ... compartir sus mejores prácticas por el mundo y tratar ... Europa, África, Asia y Estados ... combina la transmisión en vivo con mensajería instantánea y ... "Imagine un médico de Medicines sans Frontieres ...
(Date:5/24/2016)...   , Study met both ... in , Excellent plus Good ... of the ascending colon   ,      ... announced new positive data from the phase III MORA study for ... litre PEG with ascorbate. The study met both primary endpoints showing ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... ... Southland Log Homes , designer and manufacturer of America’s Favorite Log ... be found on its website at SouthlandLogHomes.com. , The designs of the wood ... craftsmanship of timber post and beam construction. The result is a barn that ...
(Date:5/27/2016)... ... May 27, 2016 , ... An influential resource amongst nurses and professionals in ... lights on the variety of topics detailing why we appreciate nurses in so many ... career has gone from being in a major recession to one of the hottest ...
(Date:5/27/2016)... ... May 27, 2016 , ... An educational ... by inspiring human-interest stories, courtesy of awareness-driven celebrities and thought leaders. It also ... advocates, associations and industry leaders such as Bioness. , As patients feel ...
(Date:5/27/2016)... ... May 27, 2016 , ... ... bolstered by inspiring human interest stories, courtesy of leaders in the nursing and ... within the industry, from leading advocates and associations—namely Jones & Bartlett Learning. , ...
(Date:5/27/2016)... ... 27, 2016 , ... With a team of certified experts, ... Aside from its GMP accreditation, Validation Center is also a registered authority of ... and staff. , Validation Center is ISO17025 accredited and only offers its clients ...
Breaking Medicine News(10 mins):