Diagnostic imaging  

GE Healthcare's next-generation digital mammography system approved by US FDA

23 April 2006

GE Healthcare, a unit of General Electric Company (NYSE:GE), has received U.S. Food and Drug Administration (FDA) approval for its new mammography platform, the Senographe Essential. 

The Senographe Essential is the next-generation of GE's proven Senographe full field digital mammography systems. An advanced digital detector gives improved imaging capability and a 24 x 31 cm detector size offers the largest active field of view in the industry. At low doses it delivers the industry's highest Detective Quantum Efficiency (DQE) — the new standard for quantifying digital X-ray image quality.

Folke Lindberg, General Manager of Global Mammography, GE Healthcare said, "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.

The 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 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 Advantage multi-modality breast imaging workstation are the 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.

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