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:5/28/2016)... ... 2016 , ... After a year and a half of planning the Multiple Pathways of ... Multiple Pathways of Recovery Conference was held May 2 -4, 2016 at the Mystic ... came together to explore the many pathways individuals use to get into and sustain their ...
(Date:5/27/2016)... ... May 27, 2016 , ... Two director-level employees of Horizon Blue Cross Blue ... Industry (TWIN) 2016 honorees. The award recognizes businesswomen who excel in their fields ... Director of the MLTSS (Managed Long-Term Services and Supports) Program at Horizon NJ Health ...
(Date:5/27/2016)... ... , ... This campaign aims to provide a path to improved education and ... and change. , As nearly 795,000 Americans suffering from a new or recurrent stoke ... with an estimated 129,000 of these people dying from stroke, it’s become our nation’s ...
(Date:5/27/2016)... ... 27, 2016 , ... Aimed at nurses and employees in ... courtesy of leaders in the nursing and health care industry. It also provides ... and associations—namely Jones & Bartlett Learning. , Jones & Bartlett Learning is adding ...
(Date:5/26/2016)... ... ... Despite last week’s media reports hinting at a June rate hike after the ... for an interest rate increase, according to Rajeev Dhawan of the Economic Forecasting Center ... Market Committee (FOMC) dot charts are of interest to the press for their noise ...
Breaking Medicine News(10 mins):
(Date:5/27/2016)... PUNE, India , May 27, 2016 ... in the instances of hypertension is driving ambulatory blood ... muscles lose their elasticity and their ability to respond ... blood pressure. This condition can lead to various cardiovascular ... and peripheral vascular disease. These diseases are growing in ...
(Date:5/26/2016)... , May 26, 2016 According ... "Medical Waste Management Market - U.S. Industry Analysis, Size, Share, ... management market in the U.S. was valued at US$ 5.89 ... CAGR of 3.4% from 2015 to 2023 to reach US$ ... analysis of current and emerging needle free drug delivery devices ...
(Date:5/25/2016)... May 25,2016 FDA 510(k) ... Cellvizio platform for urological and surgical applications ... inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy ... in the US with the 12 th ... Administration (FDA). This new FDA clearance covers Confocal ...
Breaking Medicine Technology: