Navigation Links
FDA OKs First Ultrasound Imaging System for Dense Breasts
Date:9/18/2012

TUESDAY, Sept. 18 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first ultrasound device to detect breast cancer in women with dense breast tissue, for use along with standard mammography for women with no symptoms of breast cancer, the agency announced Tuesday.

About 40 percent of women have dense breasts, which can make standard mammograms more difficult to interpret, according to the U.S. National Cancer Institute. Dense breasts have more connective and glandular tissue than less-dense breasts, which contain more fatty tissue.

On regular mammograms, dense breast tissue appears as solid white areas -- and so do tumors. Smaller tumors may be hidden by dense breast tissue, possibly delaying cancer detection, the FDA said in a news release.

Using high-frequency sound waves and computer analysis, however, ultrasound can detect tumors even in dense breasts. The somo-v Automated Breast Ultrasound System (ABUS), with a specially shaped transducer, can scan an entire breast and produce several images for physician review in about a minute, according to the FDA.

Approval came following a study of 200 healthy women with dense breasts and negative mammograms (ones that did not show cancer). Board-certified radiologists reviewed mammograms alone or along with ABUS images. Significantly more breast cancers were detected when ABUS and mammograms both were used, the agency said.

"A physician may recommend additional screening using ultrasound for women with dense breast tissue and a negative mammogram," said Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA's Center for Devices and Radiological Health. "The somo-v ABUS is a safe and effective breast ultrasound tool when such screening is recommended."

Breast cancer is the second leading cancer-related cause of death among American women. Nearly 227,000 women will be diagnosed with breast cancer this year, and more than 39,500 will die from the disease.

U-Systems Inc., based in Sunnyvale, Calif., markets the ultrasound device.

More information

The American Cancer Society explains the importance of early breast cancer detection.

-- Lisa Esposito

SOURCE: U.S. Food and Drug Administration, news release, Sept. 18, 2012


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. AIUM accredits first urological practice
2. First Pathfinder Awards announced tackling rare and orphan diseases
3. JDRF announces winners of first phase of Agnes Varis Glucose-Responsive Insulin Challenge
4. CRF announces late breaking trials and first report investigations to be presented at TCT 2012
5. Three Penn State research pioneers among first Golden Goose honorees
6. Eight scientists honored in first annual Golden Goose Awards
7. First comprehensive review of European breast cancer screening programs finds benefits outweigh harm
8. First pediatric study to look at the role of vitamin D in critical illness
9. Researchers find first evidence for a genetic cause for Barretts esophagus
10. London Olympics anti-doping labs set for first-of-a-kind repurposing
11. First validated method for analyzing flavanols and procyanidins in cocoa products could help scientists and the industry in standardized reporting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... , ... June 27, 2016 ... ... the patient payment industry today announced its strategic partnership with Connance, a ... workflows. , The two companies’ proven, proprietary technology combine to provide health ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... On June ... sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, ... of the city’s history as home to some of the world’s leading providers of ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women ... diagnosed with endometriosis. These women need a treatment plan to not only alleviate ... that can help for preservation of fertility and ultimately achieving a pregnancy. The ...
(Date:6/25/2016)... California (PRWEB) , ... June 25, 2016 , ... "With ... fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... customizable and all within Final Cut Pro X . Simply select a ProHand ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... On Friday, ... presented a Bronze Wellness at Work award to iHire in recognition of their exemplary ... part of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 2016 Dublin ... addition of the " Global Markets for Spectroscopy ... This report focuses on the ... review, including its applications in various applications. The report ... includes three main industries: pharmaceutical and biotechnology, food and ...
(Date:6/24/2016)... 2016 The Academy of Managed Care Pharmacy ... that would allow biopharmaceutical companies to more easily share ... formulary and coverage decisions, a move that addresses the ... The recommendations address restrictions in the sharing ... drug label, a prohibition that hinders decision makers from ...
(Date:6/24/2016)... SAN CLEMENTE, Calif. , June 24, 2016  American ... function testing company, is now able to perform sophisticated lung assessments ... ndd Medical Technologies , Inc. Patients are no ...  Thanks to ndd,s EasyOne PRO ® , ARL patients like Jeanne ... needed testing done in the comfort of her own home. ...
Breaking Medicine Technology: