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GE Healthcare Announces FDA 510(k) Clearance of SenoBright Contrast Enhanced Spectral Mammography (CESM) for Breast Cancer Diagnosis

October 13, 2011

Categories:
Mammography

Waukesha, WI – October 13, 2011 GE Healthcare, a unit of General Electric Company (NYSE:GE), announced today 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.

GE Healthcare’s new SenoBright1 Contrast Enhanced Spectral Mammography (CESM) 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, SenoBright 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.

“CESM presents two images per mammographic view, one that looks like standard mammography and a second image that showed the contrast enhanced areas that can help localize a lesion. As the images are familiar, it can therefore be easily reviewed by surgeons and oncologists. Moreover in terms of workflow, a CESM exam takes from 5 to 10 minutes," said Dr. Clarisse Dromain, Gustave Roussy Cancer Institute, France.

The diagnostic challenge

“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.

Clarity of results

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.

Same staff, same equipment— same day

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.

“Given our proven history of breast imaging innovations, GE is proud to showcase another innovative technology, designed to be compatible with our digital installed base. We are one of the only companies today to engineer and manufacture the entire mammography imaging chain from tube, and detector to review workstation, coupled with integration of the comprehensive local requirements for each customer,” added LeGrand.

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.

Note to Editors

1. The SenoBright option may not be available in all regions.

*Trademarks of the General Electric Company.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

Our “healthymagination” vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

For our latest news, please visit http://newsroom.gehealthcare.com

Media Contact:

Allison Cohen
Global Public Relations Manager, Oncology

GE Healthcare
+34 629 085 281
allison.cohen@ge.com

Contact Information

Verónica Botet
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Verónica Botet
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Division
GE Healthcare
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+34 629 085281
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Email
veronica.botet@ge.com