GE gets nod for remote-controlled mammography device

FDA
The 510(k) clearance for GE's Senographe Pristina follows a review of the device's image quality.

The FDA has cleared GE Healthcare to market a remote that allows patients to control compression during mammographies. GE and the FDA think giving patients some control over the amount of compression applied during exams may reduce the discomfort and associated stress they feel.

Senographe Pristina, GE’s mammography system, follows the same process as other technologies that capture 2D x-ray images of the breast. The difference is that GE’s device changes the role of the patient from passive subject to active participant. It is the patient who, under the guidance of the technologist, gradually increases the compression force up to the level needed to perform the exam. The technologist has the final say on whether the compression is adequate. 

The FDA granted 510(k) premarket notification to the device late last week and promptly put out a statement about its decision, indicating its belief in the significance of the compression-control feature. 

“Regular mammograms are an important tool in detecting breast cancer,” Alberto Gutierrez, Ph.D., director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement. “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.”

Gutierrez and his colleagues signed off on the device after reviewing a submission that showed the use of the remote control didn’t negatively affect image quality. GE also presented data showing the use of the remote control had minimal impact on the time it takes to perform exams.   

The introduction of the remote continues GE’s attempts to make the mammography experience less unpleasant. Other features of Senographe Pristina with the same goal are the use of rounded edges, a thinner image detector and armrests positioned to encourage patients to relax, not tense up, during the compression and imaging processes.  

Such features are a way for GE to differentiate its devices from rivals that generate similar images. In doing so, GE and its competitors could reduce the number of people who avoid screening exams and therefore increase the proportion of breast cancer cases that are detected early.