FDA Okays Novel System That May Reduce Mammography Anxiety

Last week, the FDA cleared the first 2D digital mammography device that allows for patient-assisted compression, according to a press release. This novel system allows patients to increase or decrease the compression applied during a mammogram.

"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."

Mammograms can detect breast cancer in early, treatable stages. This imaging technique plus better treatments show the potential to improve breast cancer survival.

Traditional mammograms are a low-dose 2D x-ray image of the breast. Digital mammograms incorporate a computer and show breast images, similar to a conventional technique. The images are then evaluated by a qualified physician to determine any abnormalities that require additional tests, according to the FDA.

The Senographe Pristina with Self-Compression is a digital mammography system that permits the patient to take an active role in test-related compression. The system includes a wireless remote that allows patients to adjust the force after breast positioning, according to the release.

During the mammography, the technician properly positions the patient and begins compression. The patient then gradually increases compression until the threshold for adequate imaging is met. The technician checks the compression and positioning and decides if adjustments are necessary.

The Senographe Pristina with Self-Compression was reviewed by the FDA through the premarket notification 510(k) pathway, which showed that the device is as safe and effective as a legally marketed device.

The FDA determined that the Senographe Pristina with Self-Compression was equivalent to the Senographe Pristina device, according to the release.

Clinical testing 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, according to the FDA.

The FDA previously granted premarketing clearance to the Senographe Pristina with Self-Compression.