Patient-assisted mammography device approved by FDA

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Patients will soon have the option to actively assist technologists with their mammography without compromising image quality and minimizing pain, using GE Healthcare’s Senographe Pristina Dueta with Self-Compression.

Now approved by the U.S. Food & Drug Administration (FDA), this is the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their breast before the x-ray is taken.

"Regular mammograms are an important tool in detecting breast cancer," said Alberto Gutierrez, PhD, 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."

Compression is used mostly to produce a clear and accurate image. It immobilizes the breast and separates the breast tissue making it conducive to “a more diagnostic image.” Compression also decreases dosage.

The system has a handheld wireless remote control that patients can use to adjust the compression force after breast positioning. During the mammography, the technologist positions the patient and initiates compression, then guides the patient to gradually increase compression using the remote control until adequate compression is reached. The technologist makes the final decision whether the compression is adequate or needs to be adjusted.

Clinical testing also showed that the addition of a remote to facilitate self-compression did not impact image quality. Additionally, a mammogram performed using patient-assisted compression did not increase the time of the exam, compared with traditional imaging.

Kathy Schilling, MD, Medical Director of the Boca Raton Regional Hospital’s Christine E. Lynn Women’s Health and Wellness Center and a clinical reviewer of the new tool said feedback from patients during the trial was positive and patients were motivated to get the best mammogram possible.

“This is game-changing for women,” Schilling said. “Reviewing the statistics, 45 percent of the images obtained had more self-compression than technologist-assisted compression.”

“Because of the new tool, I think there’s going to be better compliance amongst patients,” Schilling said. “We will be able to detect cancer in earlier stages because patients will come for their mammogram screenings.”

Currently, self-compression is only offered with 2D mammograms and is not yet widely available in clinics. Plans are in place for 3D image acquisition using the patient-assisted compression device.