Mammography Device with Patient-Assisted Compression Gets FDA Approval
The Food and Drug Administration (FDA) has approved the Senographe Pristina with Self-Compression, a digital mammography system that allows patients to increase or decrease the amount of compression applied to their breast before the mammogram X-ray is taken.
Using a handheld wireless remote control, the patient can adjust the compression force after breast positioning by a technologist. The technologist then guides the patient and checks to make sure the compression and breast positioning is adequate.
"Regular mammograms are an important tool in detecting breast cancer," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health. "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."
A clinical study of the Senographe Pristina with Self-Compression showed image quality was not negatively impacted by the addition of the remote control. Moreover, patient-assisted compression did not significantly increase the time of the exam.
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