First Breast Ultrasound Imaging System Approved

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The FDA approved U-Systems Inc.'s somo-v Automated Breast Ultrasound System (ABUS), the first ultrasound device 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. Dense breast tissue may obscure smaller tumors, which could delay detection of breast cancer.

During an ultrasound exam, a transducer directs high-frequency sounds waves towards the examined portion. Then, software analyzes the differences in how the sound waves are reflected off different tissues and back to the transducer to create an image a physician can review for abnormalities. The somo-v ABUS can automatically scan the entire breast in about one minute to produce several images for review.

The FDA reviewed results from a clinical study in which board-certified radiologists were asked to review mammograms alone or in conjunction with somo-v ABUS images for 200 women with dense breasts and negative mammograms. Results showed a statistically significant increase in breast cancer detection when ABUS images were reviewed in conjunction with mammograms, as compared to mammograms alone.

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