Automated Breast Ultrasound System Receives Approval for Screening Women with Dense Breasts

The US Food and Drug Administration (FDA) has approved a new breast imaging technology, an automated breast ultrasound system (ABUS), which is designed to help identify 35.7% more tumors in women with dense breasts than mammograms alone.

GE Healthcare (Chalfont St. Giles, UK) is deploying the first Invenia ABUS installations with Fairfax Radiological Consultants (FRC; Fairfax, VA, USA) just outside of Washington DC (USA), and Phelps Memorial Hospital (Westchester, NY, USA) whose healthcare providers are now able to offer women with dense breast tissue an efficient, comfortable, and non-ionizing screening solution.

“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. “Mammography is still considered the gold standard for breast cancer screening but is less sensitive in women who have dense breast tissue. Supplementing the mammogram with automated breast ultrasound screenings should help us find tumors that cannot be seen on the mammogram and at an earlier stage than would have otherwise been found. We are optimistic that this more personalized screening approach can help us save more women’s lives.”

The Invenia ABUS optimizes the patient experience by using three-dimensional (3D) ultrasound technology to rapidly and comfortably image women with dense breast tissue in about 15 minutes with new features that conform to a woman’s body and provide more enhanced images. This launch comes at a critical time when there is growing awareness of the increased risk of cancer for women with high breast density. The more dense breast tissue a woman has, the higher her risk of developing breast cancer, frequently up to four to six times greater risk than women who do not have dense breast tissue.

“Phelps Memorial Hospital Center prides itself on keeping up with cutting-edge technologies and we are very excited for our hospital and community to integrate this new technology into our mammography program,” noted Michael Glennon senior administrative director of Ancillary Services at Phelps Memorial Hospital. “This highly sophisticated ABUS is more efficient than the traditional ultrasound exam and will significantly enhance our diagnostic capabilities and potentially improve outcomes for our patients.”

Appreciating that breast cancer screenings can be an emotionally worrying experience for the patient, GE Healthcare has designed the Invenia ABUS with the patented Reverse Curve transducer to conform to a woman’s anatomy, for enhanced comfort and image performance. Furthermore, the system uses Compression Assist, an application that applies light levels of compression automatically to the breast for increased ease and image reproducibility. Following on the initial Fairfax and Westchester launches, GE plans to roll out the Invenia ABUS in the United States in 2014, with healthcare providers across the United States.

“We are excited about launching our most innovative and intuitive ABUS system yet, the Invenia ABUS, and are proud to make our first installs at the renowned facilities at Fairfax Radiological and Phelps Memorial,” said Anders Wold, president and CEO of GE’s ultrasound business. “As part of our ongoing commitment to improving women’s health, GE Healthcare is focused on providing timely and meaningful technological innovations spanning the care continuum, including those for the screening of patients with dense breasts.”

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