Healthcare Industry News:  telemedicine 

Devices Radiology FDA

 News Release - April 20, 2006

U.S. FDA Approves GE Healthcare's Next-Generation Digital Mammography System for Improved Breast Care

New Senographe Essential is Fully Equipped with Automatic Optimized Digital Workflow Functions

Offers Largest Field of View in the Industry

WAUKESHA, Wis.--(HSMN NewsFeed)--April 20, 2006--GE Healthcare, a unit of General Electric Company (NYSE:GE ), today announced that it has received U.S. Food and Drug Administration (FDA) approval for its new mammography platform that will improve the standard of care for millions of women around the world. The SenographeŽ Essential is the next-generation of GE's proven Senographe Full Field Digital Mammography systems.

The new Senographe Essential will enhance the way clinicians can evaluate women for breast cancer, by enhancing image quality. With a 24 x 31 cm detector size, the Senographe Essential offers the largest active field of view in the industry. The foundation of the Senographe Essential imaging excellence is GE's advanced digital detector, which at low doses delivers the industry's highest Detective Quantum Efficiency (DQE) - the new standard for quantifying digital X-ray image quality.

"GE is the choice of today and the partner of tomorrow for breakthrough advancements in breast imaging," said Folke Lindberg, general manager of Global Mammography, GE Healthcare. "We are changing the way we fight breast cancer with digital mammography, by designing the Senographe Essential to meet all the clinical needs of screening and diagnostic procedures on one system to optimize workflow."

Digital Mammography Study

In the largest cancer screening trial in history, published in September by the National Cancer Institute (NCI) and the American College of Radiology Imaging Network (ACRIN), GE's Senographe digital mammography system was used for more exams than any other digital system (44%). The study reported that while film and digital images are equally accurate for many women, digital mammograms had higher sensitivities for three sub-groups of women: women under 50, women with heterogeneous or very dense breast tissue, and pre- or perimenopausal women.

"Just as consumers have moved from traditional film cameras to digital cameras, the medical community is rapidly adopting digital mammography tools that enable high quality, more accessible images" said Jennifer Conner, director of Breast Imaging, GE Healthcare. "Film is still a good technology, just as it is in cameras, but we think digital has advantages, particularly in its efficiency. We will continue to invest in research and development to improve mammography technology," said Conner.

In 2000, GE was the first company to introduce full-field digital mammography for patient use, and today there are more than 1,500 GE Senographe systems in use worldwide. More than 25 million women have been examined using GE Senographe FFDM systems. GE Healthcare spent 15 years and more than $200 million developing the Senographe systems' Revolution digital flat panel technology. As a result, GE holds more than 160 U.S. patents for its exclusive digital flat panel X-ray technology.

New Addition to the Senographe Family

The new Senographe Essential is the latest addition to the GE Healthcare Senographe family of products. Introduced in early 2004, the Senographe DS was the first and only full-field digital mammography system designed to meet all the clinical needs from screening, diagnostic to interventional procedures, using the same detector to optimize image quality and workflow.

The Senographe product line and Seno AdvantageŽ multi-modality breast imaging workstation are cornerstones of GE's breast imaging offerings, a complete imaging and information management solution to help healthcare professionals detect breast cancer earlier and treat it more effectively. The system has a patient-centric design and intuitive controls that allow the technologist who performs the exam to focus on her patient and makes the mammography exam an easier and more comfortable experience. The new Essential system builds on this platform of excellence.

GE Healthcare is the only manufacturer in the industry today that provides the entire mammography imaging chain from tube, detector to review workstation - and integrates comprehensive customer needs into our roadmap for the future.

The benefits of GE's Senographe systems include:
  • Better visibility of the breast, particularly near the skin line, the chest wall and in women with dense breast tissue;

  • Exams can take less than half the time, with the incredibly fast signal readout of GE's advanced detector design, with the ability to quickly generate images and the optimized, highly automated digital workflow;

  • Fewer call backs for patients. The flexibility to magnify and manipulate digital images can provide more clinically relevant information and therefore can eliminate some call backs that are necessary with traditional film-based mammography systems;

  • The advancement of telemedicine, allowing breast images to be sent anywhere in the world electronically and be reviewed on a computer; and,

  • Electronic archival of patient images means easier retrieval and transmission of patient information to healthcare providers.
About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform and treat disease, so their patients can live their lives to the fullest.

GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $15 billion unit of General Electric Company (NYSE:GE ). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at

Source: GE Healthcare

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