Patients will be able to adjust the compression applied to their own breasts under a newly approved 2D digital X-ray mammography system, the Food and Drug Administration has announced.
“Some patients may experience anxiety or stress about the discomfort from the compression during the mammogram,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “This device allows patients some control.”
A conventional mammogram is a low-dose 2D X-ray picture of the breast to detect possible cancer. Digital mammograms use a computer along with X-rays to create pictures, which are taken in the same way as a conventional mammogram.
The Senographe Pristina with Self-Compression, from GE Healthcare, has a handheld wireless remote control that patients can use to adjust the compression after positioning the breast. A technologist guides the patient to gradually increase compression using the remote control until adequate compression is reached.
The new device was reviewed to demonstrate that it is at least as safe and effective as a current legally marketed device. The FDA determined that allowing self-compression through the remote control system did not negatively affect the image quality and that performing a mammogram with patient-assisted compression did not significantly increase the time of the exam.
The U.S. Preventive Services Task Force recommends a mammogram every two years for women ages 50 to 74.
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