FDA Approves Patient-Assisted Mammography

New digital mammography system allows the patient to have some say on the amount of pressure that is applied during an exam.


Women of all ages and sizes will be glad to know that they now have some say in the amount of pressure applied to the breast during a mammography. The FDA has cleared Senographe Pristina with Self-Compression, the first patient-assisted 2D digital mammography system.

Related: Patient Knowledge of and Barriers to Breast, Colon, and Cervical Cancer Screenings: A Cross-Sectional Survey of TRICARE Beneficiaries

Digital mammograms use a computer along with x-rays. During an exam with the new system, the technologist positions the patient and initiates compression, then guides the patient in using the handheld wireless remote control to adjust the compression to a comfortable level. The technologist makes the final decision on whether the compression is adequate.

Related: USPSTF Supports Mammography Starting at Age 50

A clinical validation demonstrated that the addition of a remote to allow self-compression did not negatively affect image quality. Nor did allowing the patient to help with adjustments make the exam take significantly longer.

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