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 improve
'/>"/>

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

Page: 1 2

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:8/21/2014)... August 21, 2014 BreedIT ... Ltd., the exclusive worldwide license holder and distributor ... breeders and researchers, today is pleased to announce ... with Seach Ltd, a leading Israeli medical Cannabis ... and develop new breeds of medical Cannabis to ...
(Date:8/21/2014)... 21, 2014  AliveCor, Inc. announced today ... (FDA) has granted the company clearance for ... the most common form of cardiac arrhythmia. ... if patients are experiencing AFib through real-time ... phone based AliveCor® Heart Monitor, so physicians ...
(Date:8/21/2014)... Mass. , Aug. 21, 2014   ... AEX: PHIA) today announced it has received 510(k) ... to market its precision planning application for Transcatheter ... Philips TAVI application provides interventionalists with pre-procedural, high-precision ... The Philips TAVI planning application is available as ...
Breaking Medicine Technology:BreedIT Ltd. and Seach Ltd. Form KanaboSeed to Develop New Medical Cannabis Varieties 2BreedIT Ltd. and Seach Ltd. Form KanaboSeed to Develop New Medical Cannabis Varieties 3BreedIT Ltd. and Seach Ltd. Form KanaboSeed to Develop New Medical Cannabis Varieties 4AliveCor Receives First FDA Clearance to Detect a Serious Heart Condition in an ECG on a Mobile Device 2Philips receives FDA 510(k) Clearance for TAVI Precision Treatment Planning Application 2Philips receives FDA 510(k) Clearance for TAVI Precision Treatment Planning Application 3
... 2011 myMatrixx®, a full-service pharmacy and ancillary medical ... Phil Walls, R.Ph., Chief Clinical & Compliance Officer, has ... The first is Health Care Heroes hosted by the ... finalist in the Medical Professional Non-Physician category. Phil will ...
... Inc. dba Discharge 1-2-3 of Schaumburg, IL, ... the 2011 Chicago Innovation Awards.  The ten winners will be ... Chicago,s Harris Theater that evening. The Chicago Innovation ... recognition of the most innovative new products or services brought ...
Cached Medicine Technology:myMatrixx's Phil Walls, R.Ph. Receives National and Regional Recognition 2Callibra, Inc. dba Discharge 1-2-3™ is Named Top 75 Nominee for 10th Annual Chicago Innovation Awards 2
(Date:8/22/2014)... August 22, 2014 Teen substance abuse ... Columbus, OH. Unfortunately, most young adults never receive the ... in the community, the new Troubled Teens Columbus helpline ... seeking to overcome their drug and alcohol dependencies ... 902-4644, teens and their parents can speak directly to ...
(Date:8/22/2014)... 2014 The rising numbers of teenage ... Over the years, countless lives have been lost due to ... in the community a new helpline was established to provide ... Northeast Ohio who are seeking to overcome their chemical dependency ... at (300) 400-2616, parents and their teens can speak immediately ...
(Date:8/22/2014)... According to the market research report "Blind ... (ACC) System Market for Passenger Cars; by Geography ... by MarketsandMarkets, classifies and defines the automotive BSD ... and value. The report highlights potential growth opportunities ... review of the market drivers, restrains, growth indicators, ...
(Date:8/21/2014)... Os-Monitor.com, an outstanding online supplier of useful ... software collection ( http://www.os-monitor.com ). In addition to ... these high end items are offered with greatly ... improving productivity, the employers pay more attention to ... and network monitoring software products are becoming more ...
(Date:8/21/2014)... Strongly influenced by their self-interest, ... there are no consequences, researchers in Georgia State ... This could imply that humans are less concerned ... researchers said. Their findings are published in the ... of unfairness is affected by their self-interest, indicating ...
Breaking Medicine News(10 mins):Health News:New Helpline in Columbus Assists Troubled Teen Find Youth Rehab 2Health News:Troubled Teens in Akron, OH Can Receive Assistance from New Helpline for Addiction Recovery 2Health News:Automotive Blind Spot Detection System Market Worth $2.8 Billion and Automotive Adaptive Cruise Control System Market Worth $6.1 Billion by 2019 – New Report 2Health News:Automotive Blind Spot Detection System Market Worth $2.8 Billion and Automotive Adaptive Cruise Control System Market Worth $6.1 Billion by 2019 – New Report 3Health News:Automotive Blind Spot Detection System Market Worth $2.8 Billion and Automotive Adaptive Cruise Control System Market Worth $6.1 Billion by 2019 – New Report 4Health News:New Employee Monitoring Software Collection Unveiled By Os-Monitor.com 2Health News:Influenced by Self-Interest, Humans Less Concerned About Inequity To Others, Researchers Find 2Health News:Influenced by Self-Interest, Humans Less Concerned About Inequity To Others, Researchers Find 3
... milks, yogurts and desserts grew by 22 per cent in ... and more aware of food intolerance and allergies. //, ... further expected to grow in the next three years. According ... over 130 new product introductions of Soya-based drinks & desserts, ...
... the difference in genes might be responsible for the ... differ in reacting to medications. //, ,The study, ... Chicago, had found that children with a variant form ... to be associated with ADHD -- responded poorly to ...
... soon begin training sex workers in the state to ... the provision of $12.7 million for the project to ... to train sex workers on an alternative employment scheme ... workers recommended that they be trained in setting up ...
... have become nearly twice as prevalent in high schools in ... of middle school students admit that drugs are used, kept ... schools where drugs are widely available are three times more ... use alcohol than their peers who attend drug-free schools., ...
... two centuries ago by a German physician, is finding ... conventional medicine still views it with scepticism. //, ... on the idea of "like cures like"., ... was prescribed to combat malaria but also caused malaria-like ...
... pointed out that city people who are more exposed to ... the greenery may be more likely to become obese than ... this interesting research were published in the latest edition of ... studies have suggested that place of residence may be associated ...
Cached Medicine News:Health News:Popularity Of Homeopathy On The Increase 2Health News:Popularity Of Homeopathy On The Increase 3Health News:Exposure To Greenery And Graffiti May Affect Obesity 2
... selecting an oxygen conserver, it's important to have ... Now allied, a name synonymous with innovative excellence, ... Liberty™, two totally automatic and value packed conservers., ... Liberty can be used 8 hours a day ...
Proven and Efficient Stand-Alone Device. Offers a choice between alternate breath and every breath delivery. This model provides every breath delivery....
Lightweight Pneumatic Conserver., ,NOTE: All models passed the ASTM PS 127-00 regulator ignition safety test....
... ,Offers an average 5:1 increase in usage ... use of a standard cannula. , ,The ... offers ambulatory oxygen patients a superior alternative to ... 2-year warranty. , ...
Medicine Products: