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FDA Approves New Mammography System

FDA news release; 2017 Sep 1

Publish date:: September 5, 2017

The FDA has cleared 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 is a digital mammography system designed to give the patient an active role in the application of compression. The system has a handheld wireless remote control that patients can use to adjust the compression force after breast positioning.

Approval was based on a clinical validation showing that the addition of a remote to allow self-compression did not negatively impact image quality, nor did it significantly increase the time of the exam.

Citation:

FDA clears mammography device with option for patient-assisted compression. [news release]. Silver Spring, MD: FDA. September 1, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574562.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed September 2, 2017.

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