The FDA has granted 510(k) approval to a first of its kind 2D digital mammography system that allows patients adjust the amount of compression applied to the breast before the mammogram is taken, according to a press release from the FDA.
“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 the release. "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 is a mammography system designed to give the patient an active role in the application of pressure. The system has a handheld wireless remote control that patients can use to adjust the compression force after breast positioning.