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08-09-2017 | Breast cancer | News | Article

approvalsWatch

Self-compression mammography device meets US FDA approval

medwireNews: The US FDA has granted approval for use of the Senographe Pristina with Self-Compression digital 2-dimensional mammography system.

“[S]ome patients may experience anxiety or stress about the discomfort from the compression during the mammogram,” commented Alberto Gutierrez, from the FDA’s Center for Devices and Radiological Health, in a press release.

“This device allows patients some control over the amount of compression for their exam."

Guided by a technologist, the patient can use a remote control to adjust the force of compression after breast positioning. The premarket submission to the FDA demonstrated that the self-compression facility does not affect patient safety, alter imaging quality, or significantly increase examination time relative to the predicate device.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group

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