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:6/7/2017)... Md. , June 7, 2017  Novavax, Inc., (Nasdaq: ... second of two Phase 2 trials of its RSV F ... of child bearing age have been published in the journal ... publication have been shared in prior scientific conferences). The Company ... in April 2014. Novavax is developing the RSV F Vaccine ...
(Date:6/5/2017)... Neb. , June 5, 2017 ... in the United States . ... helps a fallen person up to an almost-standing ... easily assembled and operated by one assistant and does ... It is simple enough that a child can operate ...
(Date:6/1/2017)... 1, 2017 Nutriceutical Holdings (NH), parent company ... (VRS), and KD Pharma Group have decided to join ... KD Pharma Group. KD Pharma Group will become the ... acquire the entire company. "We believe we ... committed to growing the NH companies by providing us ...
Breaking Medicine Technology:
(Date:6/24/2017)... , ... June 24, 2017 , ... ... offering genetic testing for medications in select Florida and Texas doctors' offices and ... , This new application of genetic testing recognizes the role genes play in ...
(Date:6/24/2017)... Waco, TX (PRWEB) , ... June 24, 2017 , ... ... opportunity to spend time outdoors. Home and business owners should be aware that the ... to the lake. In fact, mechanical locks and keys can be negatively affected from ...
(Date:6/23/2017)... ... June 23, 2017 , ... "The ... will ultimately do significant harm to people with all chronic conditions, including mental ... it leaves in place the Affordable Care Act (ACA) requirement that insurers cover ...
(Date:6/23/2017)... ... ... Studies show evidence that carotenoids and antioxidants derived either from the diet ... , But how often do ophthalmologists and optometrists in Sweden recommend the use of ... with early symptoms of AMD? A study published recently in Dove Medical ...
(Date:6/23/2017)... ... June 23, 2017 , ... Military Connection friend ... entry to the JFK Virgin Atlantic lounge. , Bensko is no stranger to ... years ago, Bensko dedicated her life to supporting our wounded veterans. A world-class photographer, ...
Breaking Medicine News(10 mins):