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FDA Approves New Ultrasound Device ABUS

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123Donna View Drop Down
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    Posted: Apr 11 2012 at 10:33pm

FDA Panel Approves Ultrasound Device for Spotting Hidden Breast Tumors

A U.S. Food and Drug Administration panel today approved the widespread use of an automated ultrasound machine that would give doctors a detailed image of dense breast tissue, helping them to spot cancerous tumors.

The FDA reviewed the safety and effectiveness of the Automated Breast Ultrasound, a device that uses an automated, Xerox-like system to get ultrasound images of breast tissue. ABUS is intended to screen women with dense breast tissue, for whom traditional mammograms may be inadequate.

"We know that mammography is limited by breast density," said Robert Smith, senior director of cancer screening at the American Cancer Society. "Sometimes the glandular tissue is so dense that radiation doesn't penetrate it. You can't see anything."

The dense tissue makes it easy for tumors to hide on traditional mammograms.

Some research estimates that about 40 percent of women have dense breast tissue.

According to ABUS' manufacturer, U-Systems, the device provides 3-D images of breast tissue and is intended for use along with mammograms, not in place of them, and to "increase breast cancer detection" in women with dense breasts who have already received a benign mammogram.

"This panel review, part of the FDA process for assessing new technology, brings us one step closer to an approved adjunctive screening tool for women with dense breasts," said Ron Ho, president and chief executive officer of U-Systems, in a statement.

Some say ultrasound is a valuable tool for finding breast tumors not easily spotted with other tests. Others say greater detection of abnormal spots on ultrasounds would lead to more biopsies but not necessarily better outcomes for women with breast cancer.

Mammograms are the gold standard of breast cancer screenings, and the U.S. Preventive Services Task Force recommends that women over age 50 get a mammogram once every two years to screen for breast cancer. Some groups, such as the American Cancer Society and the American College of Obstetrics and Gynecology, recommend that women begin getting mammograms at age 40.

For women at an increased risk of breast cancer, such as those with dense breasts or those who have had breast cancer before, doctors may use additional screening tools, such as MRIs or ultrasound, to check their breasts for problems.

http://abcnews.go.com/Health/fda-reviews-automated-breast-ultrasound-device/story?id=16119592#.T4Y-IlHy-Ro

http://abclocal.go.com/kabc/story?section=news%2Fhealth%2Fyour_health&id=8617537

DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
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Post Options Post Options   Thanks (0) Thanks(0)   Quote sabinecalifornia Quote  Post ReplyReply Direct Link To This Post Posted: Apr 12 2012 at 12:22pm
Hello Donna,
 
thank you very much for the information.
 
Have a great day
Sabine
DX TNBC 7/11 @ age 50, Stage 2A Grade 3, 1/19, LE/AD 8/11, BRCA1/2 neg.,
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Apr 27 2012 at 1:55pm
On April 11, 2012, a U.S. Food and Drug Administration (FDA) expert panel recommended that an automated ultrasound device be approved for breast cancer screening in women with dense breasts. 

DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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