FDA Approves Ultrasound Imaging Device for Dense Breast Tissue
The U.S. Food and Drug Administration (FDA) has approved the somo-v Automated Breast Ultrasound System (ABUS) for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer.
Breast cancer is the most commonly diagnosed type of cancer (other than skin cancer) in U.S. women. Each year, roughly 227,000 women are diagnosed with breast cancer and close to 40,000 die of the disease.
Breast density refers to the extent of glandular and connective tissue in the breast. Breasts with more glandular and connective tissue—and less fat—are denser. Breast density can be assessed by mammography. The National Cancer Institute estimates that about 40 percent of women undergoing screening mammography have dense breasts. Women with higher breast density are at increased risk of developing breast cancer.
Mammograms of dense breasts can be difficult to interpret. Dense breast tissue can obscure smaller tumors, which can delay the detection of breast cancer. The somo-v ABUS is an ultrasound device that can detect small masses in dense breasts. It has a specially shaped transducer (a device that directs high-frequency sound waves at the area of the body being examined) that can automatically scan the entire breast in about one minute and produce several images for review.
The approval was based in part on the results of a clinical study in which board-certified radiologists reviewed mammograms alone or in conjunction with images from the somo-v ABUS for 200 women with dense breasts and negative mammograms. Biopsies were then performed on masses detected with the somo-v ABUS in order to determine if they were cancer. The results indicated a statistically significant increase in breast cancer detection with somo-v ABUS images plus mammogram, compared to mammograms alone.
The procedure is approved for use in women who have not had previous surgery or biopsy since these procedures could alter the appearance of breast tissue in ultrasound images. As part of the approval, the FDA is requiring the manufacturer to provide thorough training for physicians and technologists, along with a manual that clearly defines system tests required for initial, periodic, and yearly quality control measures.
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