GE Healthcare wins FDA nod for mammography system with patient controlled compression

GE Healthcare (NYSE:GE) said yesterday it won FDA 510(k) clearance for its Senographe Pristina Dueta, which it claims is the 1st patient-assisted mammography device that allows women to control their own compression during the examination.

With the system, the woman undergoing the exam can control the application of compression on their breasts to minimize perceived pain and discomfort that is often associated with a mammogram, the company 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,” Dr. Kathy Schilling of the Boca Raton Regional Hospital’s Christine E. Lynn Women’s Health & Wellness Center said in prepared remarks.

GE Healthcare said the Senographe Pristina was totally redesigned, and replaced traditional design with rounded edges and a thinner image detector for a less painful, more comfortable experience during exams.

“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. No woman should miss out on the potentially life-saving benefits of regular mammograms out of fear or anxiety of discomfort. 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,” women’s health prez & CEO Agnes Berzsenyi said in a prepared statement.

Last month, GE Healthcare said it won FDA 510(k) clearance for its Signa Premier wide bore 3.0 Tesla magnetic resonance imaging system.

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