Navigation Links
FDA Approves First 3D Mammogram Device
Date:2/14/2011

FRIDAY, Feb. 11 (HealthDay News) -- The U.S. Food and Drug Administration approved on Friday the first X-ray mammography device that provides three-dimensional images of the breast for cancer screening and diagnosis.

The Selenia Dimensions System, an upgrade to Massachusetts-based Hologic Inc.'s FDA-approved two-dimensional 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, the FDA said in a news release.

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

A mammogram is a low-dose X-ray of the breast and is considered the best tool for early detection of breast cancer. But, with conventional two-dimensional imaging, an estimated 10 percent of women must endure additional testing because an initial screening exam found abnormalities that were later determined to be noncancerous, the agency said.

The combined use of the Selenia's 2-D and 3-D images roughly doubled the amount of radiation a patient received. But, it improved accuracy, decreasing the number of women called back for additional testing, the FDA said. The agency added that there is uncertainty about 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 U.S. National Cancer Institute recommends that 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 two-dimensional and three-dimensional images from more than 300 mammography exams. In both studies, the radiologists viewing both the 2-D and 3-D images realized a 7 percent improvement in their ability to distinguish between cancerous and non-cancerous cases, compared to viewing 2-D images alone, the agency said.

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

More information

To learn more about mammograms, visit the U.S. National Library of Medicine.

-- HealthDay staff

SOURCE: Feb. 11, 2011, news release, U.S. Food and Drug Administration


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Kaiser Permanente Approves $170 Million in Community Benefit Grants in 2009
2. The American Association of Anatomists approves guidelines for body donation programs
3. Golden Meditech Shareholders Approves of Name Change
4. New Jersey Approves Initiative to Expand the Number of Wound Care Certified Professionals
5. Congress Approves Bill Curbing Internet Tobacco Sales in Victory for Kids and Taxpayers
6. House of Representatives Approves Health-Care Reform Bill
7. New York State Office of Mental Health Approves New High Performance Polycarbonate Sheet for Use in All Facilities
8. FDA Approves Stemedica IND for Ischemic Stroke Clinical Trial
9. FDA approves first human neural stem cell clinical trial to treat brain tumors
10. Early detection of cancer: The FDA approves procedure discovered by EPFL researchers
11. FDA approves Merz Pharmaceuticals Xeomin (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... ... ... Park Cities Pet Sitter has openings for both full-time and part-time pet ... 75220, 75225, 75229, 75230, 75231 and 75235 zip codes. These zip codes are ... Park Cities areas of the Metroplex. Candidates must love animals, have attention to ...
(Date:5/3/2016)... ... May 03, 2016 , ... Intrigma, the leading provider of ... is expanding its use of Intrigma’s cloud-based physician scheduling solution, Efficient Scheduler (a ... concept. The Portland, Oregon based health system conducted a one-year pilot of the ...
(Date:5/3/2016)... (PRWEB) , ... May 03, 2016 , ... Dr. Poneh ... on cosmetic dental treatments to both new and existing patients. Cosmetic dentistry allows patients ... for patients who have healthy smiles with some minor or more serious cosmetic flaws. ...
(Date:5/3/2016)... ... , ... Branches, Inc. is proud to have been selected as a Macy’s ... South Miami. Macy’s is a wonderful community partner and has helped to support Branches’ ... enrichment and academic support to elementary students 5 days a week. Summer Shade, a ...
(Date:5/3/2016)... ... May 03, 2016 , ... Hydra Skin Sciences, a top-rated skincare company ... a revolutionary new anti-aging skin care product that integrates Snow Algae Powder ... sold over seventy-five thousand units worldwide within the first two months of release. , ...
Breaking Medicine News(10 mins):
(Date:5/2/2016)... May 2, 2016 Leading Economies with Fastest Real GDP ... d,Ivoire 8.6 Uzbekistan 8 Ireland 7.8 India 7.3, , Source: ... nations , which comprises of Brazil , Russia ... South Africa , registered the fastest GDP growth during the ... China , recession in Brazil and ...
(Date:4/29/2016)... 29, 2016  In the next ten years, ... from systems dependent on CRTs monitors to those reliant ... CRT Medical monitors and will automatically sync to ... of foreseeable benefits to this technological advancement, it ... have to be replaced in order to be ...
(Date:4/29/2016)... Automation is one of the ... the growing demands for productivity in speed, accuracy, throughput ... are already adept of a wide range of functions ... labor. Instrumentation continues to evolve, and is poised to ... few years ago. Originally used mostly by the big ...
Breaking Medicine Technology: