Ultrasound Imaging System For Dense Breasts

Somo v ABUS Automated Breast Ultrasound System approved by FDA

(RxWiki News) Screening dense breasts with mammography is tricky business. That’s because some of the tissue looks like tumors on X-ray images. The U.S. Food and Drug Administration has approved a new system that makes this task simpler and more effective.

The FDA has approved the somo-v Automated Breast Ultrasound System that when combined with mammography is effective for detecting small tumors in dense breasts.

"Ask your doctor about dense breast tissue."

Dense breasts have more connective and glandular (fibrograndular) tissue than fatty tissue. About 40 percent of women receiving mammography to screen for breast cancer have dense breasts, according to the National Cancer Institute.

These women are at greater risk of developing breast cancer, and diagnosis usually comes when the cancer is more advanced and difficult to treat.

This is because dense tissue can mask tumors – both appearing as solid white spots on mammograms.

Ultrasound uses sound waves to form images and is capable of picking up small masses in dense tissue. A device called a transducer is used to produce the images that clinicians can review for irregularities.

The somo-v ABUS has a specially shaped transducer that can automatically scan the entire breast in about 60 seconds and produce several images.

The FDA approved this device after reviewing the findings of a clinical study involving board-certified radiologists. They were asked to review mammograms alone or along with somo-v ABUS images from 200 women with dense breasts and mammograms that showed nothing abnormal.

Samples from masses detected by the somo-v ABUS were biopsied to look for cancer. The study found more breast cancers were picked up when ABUS images were reviewed along with mammograms than when mammography was used alone.

“A physician may recommend additional screening using ultrasound, for women with dense breast tissue and a negative mammogram,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety at 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.”

This system was approved for women with dense breasts who have had no previous surgeries or biopsies – as scar tissue from these procedures can alter the appearance of breast tissue.

The manufacturer, as part of this approval, is required to provide thorough training and maintenance documentation for physicians and technologists using the ABUS device.

The somo-v ABUS is marketed by Sunnyvale, California-based U-Systems Inc.

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Review Date: 
September 18, 2012