GE's 3D Mammography Device Gets U.S. FDA Approval

By Reuters Staff

September 04, 2014

(Reuters) - General Electric Co's healthcare unit last week won U.S. Food and Drug Administration approval for its mammography device that produces three-dimensional images to detect breast cancer.

According to the company's website, the device, SenoClaire, uses imaging technology that combines low radiation-dosed X-rays from multiple angles to produce a superior mammogram.

The device consists of hardware and software upgrades to the company's previously launched Senographe Essential 2D full-field digital mammography system.

The hardware upgrade produces multiple, low-dose x-ray projection images of the breast. The software upgrade uses the low-dose X-ray images to create cross-sectional views of the breast. (https://1.usa.gov/1uwffyf)

Hologic Inc came up with one of the first 3-D breast imaging devices in 2001, which continues to dominate the market. Siemens AG submitted its application for the approval of its own 3-D breast imaging device in June.

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