FDA clears first 2D digital mammography system that allows patients to control the compression

Courtesy: GE healthcare 

GE Healthcare announced today FDA 510(k) clearance of an industry-first, patient-assisted mammography system, Senographe Pristina Dueta that makes mammography experience more comfortable by putting the control in patients’ own hands.

Agnes Berzsenyi, President and CEO of GE Healthcare Women’s Health said in a press release, “Mammograms can be uncomfortable or even painful. Engineered by a team of women for women, GE Healthcare has transformed mammography with the creation of patient-assisted compression to decrease pain associated with the exam, improve patient experience and increase outcomes for breast cancer screening which we know saves lives.”

The patient is handed the remote-control device with a plus and minus button on it as she is getting ready for the procedure.  In traditional mammography, the technician decides the amount of compression necessary and it often make the patient very uncomfortable. While compression is still necessary to get a good image, in this new system the patient can gradually increase the compression till the desired level is achieved.

Giving the control in patient’s hands makes them more relaxed, more cooperative and they move less, resulting in a better-quality image. A study by Gustave Roussy analyzing patient response to the new mammography system found that 83 per cent of patients surveyed were extremely satisfied with the exam.

Dr. Kathy Schilling, Medical Director of the Boca Raton Regional Hospital’s Christine E. Lynn Women’s Health & Wellness Center and the radiologist who conducted a clinical review of the new tool said, ““This is a new age in breast imaging. Patients who used the remote control said the exam was more comfortable and they were visibly more relaxed. Any breast radiologist knows that when patients are relaxed, we are able to get better images and better images lead to a more confident diagnosis. My hope is that increasing comfort during the exam and giving patients the option of working with the technologist to set their own compression will increase compliance, enable early detection and improve outcomes.”

Senographe Pristina is a totally redesigned mammography with rounded edges and a thinner image detector to create a more pleasant experience for women as well as armrests that position women to relax rather than tense up during the compression and image acquisition process.

“Senographe Pristina was designed with empathy. It humanizes the mammography experience by increasing comfort and reducing patient anxiety. The system's potential to help increase the number of annual screening exams is a critical advancement in women's healthcare.” Agnes Berzsenyi further added.