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:7/31/2017)... Mich. , July 31, 2017  Diplomat Pharmacy, Inc. ... in southeast Michigan by Crain,s ... ranks private and public companies by three-year revenue growth. This ... To view the complete list, visit ... Fast 50 is an incredible triumph," said Phil Hagerman ...
(Date:7/28/2017)... , July 28, 2017 EnvoyHealth, a Diplomat company, ... a program for CleverCap LITE, a technology designed to ... to deliver innovative health technology solutions and services that ... CleverCap LITE offers medication monitoring ... bottle cover: Records ...
(Date:7/26/2017)... July 27, 2017  Radium Medical Aesthetics, a leading medical aesthetic ... delay aging by effectively addressing several skin conditions from the inside. ... become rougher and more fragile. The skin becomes more transparent due ... to the harmful UV rays from the sun contributes to aging ... ...
Breaking Medicine Technology:
(Date:8/16/2017)... ... August 16, 2017 , ... Connexion Point, a technology-enabled healthcare services company ... fourth consecutive year. With 197% revenue growth over the past three years, ... growing companies. , Previous honors include ranking 86th on the Inc. 500 ...
(Date:8/16/2017)... ... August 16, 2017 , ... Women’s ... chronic pelvic pain. In addition to oncology services, the new center will ... menorrhagia (abnormal heavy bleeding during menstruation), uterine fibroids, and uterine and pelvic adhesions ...
(Date:8/16/2017)... ... August 16, 2017 , ... ... awards program which recognizes organizations that demonstrate the core values of business innovation, ... categories. , “As a global company, we are expanding our presence in all ...
(Date:8/16/2017)... ... ... God's Got This: Jamie's Story” is the creation of published author, Karen F. Norton, preacher, ... appetite for God’s Word. , “I froze between the half walls, shelves on my right ... I have one to this day on proud display in my dining room hutch; it ...
(Date:8/15/2017)... , ... August 15, 2017 , ... The city of Los Angeles is a west ... with “Cali Style”. LA’s Top Style List, a website that spotlights fashion news from Los ... wear their wardrobe all year long. , According to the senior editor of latsl.com ...
Breaking Medicine News(10 mins):