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GE Submits First Module of its Premarket Approval Application for GE Breast Tomosynthesis Optition

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Women's imaging news GE has provided the FDA with the device description and non-clinical information, including phantom testing, and detector performance evaluation

WAUKESHA, WI – NOVEMBER 10, 2011– GE Healthcare, a unit of General Electric Company (NYSE:GE), announced that it recently submitted to the U.S. Food and Drug Administration (FDA) the first module of its premarket approval application (PMA) for GE Breast Tomosynthesis, an option of the Senographe* Essential system.

In this first PMA module, GE Healthcare has provided the FDA with the device description and non-clinical information, including phantom testing, and detector performance evaluation. The GE Breast Tomosynthesis option has been designed as an add-on option for the Senographe Essential that will acquire multiple projection views to produce 3D Digital Breast Tomosynthesis (DBT) images intended to be suitable for screening and diagnosis of breast cancer. Over 1,200 Senographe Essentials are in clinical use in the United States today.

Earlier this summer, GE Healthcare received agreement from FDA to proceed with a PMA modular submission consistent with the application shell proposed by GE. The modular review approach is a mechanism that allows applicants to submit preclinical data and manufacturing information for FDA review while the applicant continues to collect, compile, and analyze clinical data for the submission. In short, a modular PMA is a compilation of sections or "modules" submitted at different times that together become a complete premarket approval application. The modular approach increases the likelihood that an applicant will be able to resolve deficiencies identified by FDA earlier in the review process than would occur with a traditional PMA application. GE Healthcare intends to file the remaining three modules of its DBT PMA with the FDA over the coming year.

“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.

*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.


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