Mammography Device Approved by FDA Gives Patients Control Over Pressure Levels

The FDA has approved the first 2D digital mammography system that lets patients adjust the level of compression applied to their breast during the imaging procedure.

Mammograms are a key tool in detecting breast cancer, but some women report discomfort with the procedure as it requires the breast to be compressed in order to capture a 2D x-ray image. However, the new device could potentially expand uptake of mammograms by empowering patients and making the experience more comfortable.

According to the FDA announcement, the Senographe Pristina with Self-Compression, manufactured by GE Healthcare, was approved through the premarket 510(k) pathway. GE had to demonstrate that the new device is clinically equivalent to the Senographe Pristina, an approved digital mammography device that allows the technician operating the device full control over compression.

The Self-Compression device differs from the original machine by including a wireless remote control held by the patient that can adjust the force of compression. After the technologist positions the patient’s breast, the patient is asked to use the remote control to gradually increase the level of compression to a point she finds tolerable. The technician then checks whether the compression is sufficient to achieve a clear image, and can adjust it if necessary.

Trials conducted as part of the premarket approval process confirmed that allowing patients to control compression via the new device’s remote did not worsen image quality compared with the predicate device. It also did not lengthen the average time of the mammogram compared with exams done with the technician applying compression. The finding that the new device was at least as safe and effective as the approved device contributed to the FDA’s decision to grant premarket clearance to GE for the Senographe Pristina with Self-Compression.

“Regular mammograms are an important tool in detecting breast cancer. However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram,” 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, in the announcement. “This device allows patients some control over the amount of compression for their exam.”

This sense of control, along with lessened pain and discomfort, could have significant implications for changing women’s perceptions of mammography and their willingness to undergo the screening procedure. A 2013 review published in The Breast found that between 25% and 46% of women who did not return for subsequent mammograms cited pain during the initial mammogram as the reason.