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FDA Approvals: First Ultrasound Tool for Dense Breasts

  • The FDA has approved a new automated ultrasound device to be used in combination with mammography in women with dense breast tissue. This is the first ultrasound device approved for this indication. The specially shaped transducer of the device directs high-frequency sound waves at the breast to scan the entire breast in approximately 1 minute, automatically producing several images for review.
  • The FDA has approved the ultrasound device for use only in women with negative mammography results and no symptoms of breast cancer. In these women, the device is a safe and effective breast ultrasound tool. Compared with mammograms alone, mammograms plus images generated by the new device interpreted by board-certified radiologists were associated with a statistically significant increase in breast cancer detection.
  • Unlike handheld ultrasound, automated ultrasound does not have to be operated by an imaging expert. This may be a potential drawback in that medical practitioners without specialized radiographic training could use the new device and interpret the results themselves, along with mammography findings. This could dramatically increase false-positive rates. The FDA is requiring that the manufacturer train clinicians and technologists using the new ultrasound device, and that each facility is given a manual clearly defining system tests required for quality control.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm319867.htm

 

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