22 Apr FDA approves advanced digital mammography system
Waukesha – GE Healthcare’s next-generation digital mammography system, described as a breakthrough advancement in breast imaging, has received approval from the United States Food and Drug Administration.
The system offers more evidence that the medical community is moving to adopt digital mammography tools that enable higher quality images for the detection of breast cancer. With a 24 x 31-centemeter-detector size, GE Healthcare said the Senographe Essential system offers the largest active field of view available on the market, and is equipped with optimized digital workflow functions.
An executive of GE Healthcare, a $15 billion unit of General Electric Co., characterized the system as a comprehensive approach to care that will improve the worldwide standard. “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,” explained Folke Lindberg, general manager of global mammography for GE Healthcare.
The Senographe Essential is an enhancement of the company’s Senographe digital mammography systems, which was used for more exams than any other digital system in what is considered the largest cancer screening trial in history. The foundation of the Senographe Essential is an advanced digital detector, which at low doses delivers what GE Healthcare calls “the industry’s highest Detective Quantum Efficiency” or DQE, a standard for quantifying digital X-ray image quality.
In the cancer screening trial, researchers found 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. The findings were published in September by the National Cancer Institute and the American College of Radiology Imaging Network.
Jennifer Conner, director of breast imaging for GE Healthcare, said the company will continue to invest in mammography research and development. “Film is still a good technology, just as it is in cameras, but we think digital has advantages, particularly in its efficiency,” she said.
According to GE Healthcare, there are more than 1,500 GE Senographe systems in use worldwide, and more than 25 million women have been examined using the Senographe digital flat panel technology. Among its touted benefits are faster speed – exams take less than half the usual time – and better visibility of the breast, particularly near the skin line, the chest wall, and in women with dense breast tissue.
In addition, the advancement of “telemedicine” allows breast images to be electronically sent to healthcare providers anywhere in the world, and the electronic archival of patient images has resulted in easier retrieval and transmission of patient information.
GE Healthcare spent more than $200 million over a 15-year period to develop the system, and holds more than 160 U.S. patents for it.