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FDA Approves New Mammography Device

FDA news release; 2017 Sep 1

The FDA approved the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken.

The Senographe Pristina with Self-Compression (from GE Healthcare) is a digital mammography system with a handheld wireless remote control that patients can use to adjust the compression force after breast positioning. During the exam, the technologist first positions the patients and initiates compression. The technologist then guides the patient to gradually increase compression using the remote control until adequate compression is reached.

The FDA determined that the Senographe Pristina with Self-Compression is substantially equivalent to the predicate device Senographe Pristina and a clinical validation demonstrated that the addition of a remote to allow self-compression did not negatively impact image quality.

Citation:

US Food and Drug Administration. FDA clears mammography device with option for patient-assisted compression. FDA Web site. September 1, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574562.htm. Accessed September 7, 2017.

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