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Press Release

GE Healthcare announces FDA 510(k) clearance of SenoBright CESM for breast cancer diagnosis developed in collaboration with the Qatar Science & Technology Park (QSTP)

October 18, 2011

Doha, Qatar; October 18, 2011: GE Healthcare, a unit of General Electric Company (NYSE:GE), announced the US Food & Drug Administration (FDA) 510(k) clearance of an innovative technology to aid the physician in breast cancer diagnosis. GE estimates that by 2020, more than 1 million women worldwide will be examined using SenoBright*, and this technology can help lead to more productive diagnosis paths for nearly 250,000 women.

The new SenoBright1 Contrast Enhanced Spectral Mammography (CESM) product development was carried out in collaboration between GE Healthcare and Qatar Science & Technology Park (QSTP). The goal of the joint research program is to develop new and innovative technologies for aiding in the diagnosis of breast cancer using the latest developments in digital mammography.

Aziz Koleilat, General Manager at GE Healthcare in the Middle East region, said: "Innovative ideas can have a transformational impact on our society's overall health and contribute to a better quality of living. We are pleased that SenoBright CESM was developed through our partnership with the Qatar Science & Technology Park, which demonstrates our commitment to localized research. This is in line with our commitment to the region to enable technology transfer, drive innovation and create solutions that help address the pressing healthcare challenges faced by the Middle East."

The SenoBright technology is designed to produce contrast-enhanced images of the breast using a legally approved x-ray contrast agent and a dual energy acquisition technique. Launched in 2010, it is already in use at 17 major mammography centers in France, Spain, Italy, Belgium, Germany, Austria, and Japan. SenoBright uses X-rays at multiple energies to create two separate but almost simultaneous exposures. The resulting images specifically illuminate and highlight areas of iodinated contrast.

"Worldwide, more than 1.2 million people annually are diagnosed with breast cancer. Since 1965, GE Healthcare has made significant progress in providing solutions for breast cancer detection and diagnosis that really bring a change to people's lives. Today through 'healthymagination', we continuously develop innovations to reduce costs, increase access and improve quality and efficiency of healthcare delivery around the globe," said Anne LeGrand, GE Healthcare's vice president and general manager of the company's global X-ray business.

Digital mammography is considered a relevant means of breast cancer screening, delivering proven clinical outcomes. The sensitivity and specificity of images can, however, be affected by a range of factors. Dense breast tissue can overlap with lesions, which are not always visible on an X-ray, and radiologists' interpretation of images can vary. Inconclusive digital mammography presents a range of challenges to healthcare professionals and patients. Ambiguity can result in diagnostic error.

SenoBright is intended to allow for a procedure to be conducted by the same staff, using the same mammography equipment, potentially on the same day as a traditional screening exam, thereby helping medical professionals to cut the critical time patients often have to wait from detection to diagnosis.

GE Healthcare estimates that 2500 digital mammography systems upgradeable to SenoBright are in clinical use today -- delivering an excellent investment for these customers - and providing added functionality to an existing and vital tool.

CESM technology is intended to work as an upgrade to GE Healthcare's Senographe DS* and Senographe* Essential digital mammography equipment. GE's Senographe platforms are full-field digital mammography systems designed to meet a wide range of clinical needs, from screening to diagnostic and interventional procedures.

GE has inaugurated its 20,000 sq m Advanced Technology and Research Center (GEATRC) in the Qatar Science & Technology Park (QSTP), which focuses on applied research and knowledge transfer in key areas that drive Qatar's social and economic growth including healthcare, aviation, and oil & gas.

GE Healthcare is partnering with Qatar Foundation to enable excellence in research and education that will transform the country into a global hub for healthcare innovation, entrepreneurship and research. The new learning center demonstrates the latest advances in the patient healthcare journey, and offers education and training on implementing cutting-edge clinical IT solutions from GE Healthcare and its partners. The center focuses primarily on mammography in line with the increase in breast cancer in the region.

GE Healthcare has a long history of public and private sector partnerships in the Middle East region, where it supports public and private healthcare providers with advanced technologies and solutions to address the spectrum of medical needs.

Kelly Home
ASDA’A Burson-Marsteller
[email protected]
+971 4 4507 600

Nivine William
ASDA’A Burson-Marsteller
[email protected]
+971 4 4507 600

Caroline Wehbeh
GE Communications Leader, North Africa
[email protected]
+971 4 429 6318


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