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.
To top
|