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.
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