The U.S. Food and Drug Administration cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken.

The Senographe Pristina with Self-Compression is a digital mammography system designed to give the patient an active role in the application of compression. The system has a handheld wireless remote control that patients can use to adjust the compression force after breast positioning. During a mammography exam, 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 checks the applied compression and breast positioning and makes the final decision on whether the compression is adequate or needs to be adjusted.

The Senographe Pristina with Self-Compression was reviewed through the premarket notification 510(k) pathway. A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.

The FDA determined that the Senographe Pristina with Self-Compression is substantially equivalent to the predicate device Senographe Pristina. A clinical validation demonstrated that the addition of a remote to allow self-compression did not negatively impact image quality. Additionally, performing a mammogram with patient-assisted compression compared to compression solely applied by the technologist did not significantly increase the time of the exam.

The FDA granted premarket clearance of the Senographe Pristina with Self-Compression to GE Healthcare.