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GE secures FDA approval for new 2D digital mammography system

MDBR Staff Writer Published 05 September 2017

GE Healthcare has secured approval from the US Food and Drug Administration (FDA) for its new 2D digital mammography system – Senographe Pristina with Self-Compression.

Senographe Pristina with Self-Compression enables patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is captured.

It features handheld wireless remote control to help patients adjust the compression force after breast positioning.

The technologist will position the patient and starts compression during a mammography exam. Later, he will guide the patient to gradually increase compression using the remote control until adequate compression is achieved.

Applied compression and breast positioning of the patient will be checked out by the technologist to take final decision on whether the compression is adequate or needs to be adjusted.

FDA has assessed Senographe Pristina with Self-Compression through the premarket notification 510(k) pathway.

According to FDA, the system’s clinical validation showed that the addition of a remote to allow self-compression did not negatively impact image quality and carrying out a mammogram with patient-assisted compression compared to compression alone applied by the technologist did not significantly increase the time of the exam. 

FDA in vitro diagnostics and radiological health office director Dr Alberto Gutierrez said: "Regular mammograms are an important tool in detecting breast cancer.

“However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram. This device allows patients some control over the amount of compression for their exam."


Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.