GE Healthcare Announces FDA Approval of Invenia™ Automated Breast Ultrasound System (ABUS) for Enhanced Patient Experience and More Accurate Diagnosis than Mammography Alone in Women with Dense Breasts

MILWAUKEE, June 3, 2014 /PRNewswire/ -- GE Healthcare today announced FDA approval and the U.S. launch of their new breast imaging technology, the Invenia™ ABUS, proven to help clinicians find 35.7% more cancers in women with dense breasts than mammograms alone¹.  In keeping with a strong commitment to furthering the fight against breast cancer, GE Healthcare is excited to unveil the first Invenia ABUS installations with Fairfax Radiological Consultants just outside of Washington, D.C., and Phelps Memorial Hospital Center in Sleepy Hollow, NY, 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, M.D., 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 enhances the patient experience by using 3D ultrasound technology to comfortably and quickly image women with dense breast tissue in approximately 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 cancer² – oftentimes up to 4-6 times greater risk than women who do not have dense breast tissue³.

"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 Senior Administrative Director of Ancillary Services at Phelps Memorial Hospital Center, Michael Glennon. "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."

Recognizing that breast cancer screenings can be an emotionally stressful 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 better comfort and image performance. Further, the system uses Compression Assist, a feature which applies light levels of compression automatically to the breast for increased ease and image reproducibility. Following on the initial Fairfax and Sleepy Hollow launches, GE plans to roll out the Invenia ABUS nationwide in 2014, with health providers across the country.

"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 Consultants 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."

About GE Healthcare

GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

Tackling Cancer

At GE, we envision a day when cancer is no longer a deadly disease.  In September 2011, GE Healthcare launched an ambitious global campaign against cancer, committing $1 billion of its total R&D budget over the next five years to expand its advanced cancer diagnostic and molecular imaging capabilities, as well as its  advanced technologies for the manufacture of biopharmaceuticals and for cancer research.  By the end of 2012, $335M had been invested, setting GE on track to meet its five-year commitment.  To accelerate progress, and to help clinicians deliver better care to 10 million patients by 2020, the campaign against cancer combines the strength of GE's portfolio of cancer technologies with the innovations born from collaborations with key partners.  To learn more on how GE is tackling cancer, see: http://www.getacklingcancer.com.

¹ FDA PMA P110006 summary of safety and effectiveness.
² Boyd NF et al. Mammographic Density and the Risk and Detection of Breast Cancer. NEJM 2007; 356: 227-36.   Boyd, et al, NEJM Jan 2007.
³ Tabar L, et al. Swedish two county trial: impact of mammographic. 2011;260:658 63.

SOURCE GE Healthcare