FDA Clears Mammogram Device that Lets Patients Control Pressure

The FDA on Friday approved a device to allow patients to control the pressure on their breast while undergoing a mammogram.

"Regular mammograms are an important tool in detecting breast cancer," Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, said in a statement. "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."

The Senographe Pristina with Self-Compression, made by GE Healthcare, is a digital mammography system designed to give the patient an active role in the application of compression, the agency said. The system employs a handheld wireless remote control that patients use to adjust the compression force after the breast has been positioned.

When the mammogram begins, the technologist positions the patient and initiates compression. The technologist then guides the patient to gradually increase compression using the remote control until adequate compression is reached. The technologist makes the final decision on whether the compression is adequate or needs to be adjusted.

The device was reviewed through the FDA's premarket notification 510(k) pathway, in which the manufacturer must show that the device is at least as safe and effective as a legally marketed device. The FDA determined that the Senographe Pristina with Self-Compression is substantially equivalent to an earlier model, the Senographe Pristina. A clinical validation study showed that the addition of a remote to allow self-compression did not hurt image quality or increase the time needed for the exam.