FDA Approves GE's Next-Gen Breast Ultrasound System

General Electric's Healthcare division has announced that it has received FDA approval for its Invenia Automated Breast Ultrasound System (ABUS), a next-generation breast imaging technology said to detect a third more cancers in women with dense breasts than mammograms alone. 

The company also announced the first installations of the new system, at Fairfax Radiological Consultants (FRC) just outside of Washington, DC, and Phelps Memorial Hospital in Westchester, NY.

According to GE, its, "Invenia ABUS is a comfortable, non-ionizing alternative to other supplemental screening options for women with dense breast tissue. When used in addition to mammography, Invenia ABUS can improve breast cancer detection by 35.7 percent over mammography alone."

Unlike previously approved 3-D tomosynthesis solutions that use X-rays, ABUS employs 3-D ultrasound. GE Healthcare says that ABUS's imaging architecture shifts traditional ultrasound from hardware- to software-based processing. This is said to result in improved performance. According to GE, ABUS's parallel processing power and proprietary beamforming technology create focus at every pixel to deliver an image of high uniformity and resolution.

Not intended as a substitute for mammograms, ABUS 3-D ultrasound imaging is designed as an additional screen for asymptomatic women with greater than 50 percent breast density and no prior breast interventions.

"A growing body of research suggests the importance of screening ultrasound for women with dense breast tissue--that's about 40% of women," said breast imaging specialist Elise L. Berman, MD, of Fairfax Radiological Consultants.

The more dense breast tissue a woman has, the higher her risk of developing breast cancer; GE Healthcare's literature cites studies that show that this can be up to four to times greater risk than women who do not have dense breast tissue.

Following the initial Fairfax and Westchester launches, GE plans to roll out the Invenia ABUS nationwide in 2014 at healthcare providers around the country.

Stephen Levy  is a contributor to Qmed and MPMN.