FDA approval for digital mammography allows "soft copy" reading of patient images

Waukesha 01 December 2000The U.S. Food and Drug Administration (FDA) has granted its first-ever approval for doctors to use mammography to screen and diagnose patients for breast disease directly from an advanced computer workstation, instead of reading traditional x-ray films. The procedure, called "soft copy" reading, is proven to be comparable to doctors reading patient images using x-ray films, and it is available only on the Senographe 2000D, the world's first full-field digital mammography system, designed by General Electric (GE) Medical Systems.


This breakthrough development in women's health care opens several opportunities for health care providers to make digital mammography more accessible to women in the United States. The approval comes less than ten months after the FDA approved digital image review on film, an advancement which allowed GE to market the GE Senographe 2000D in the United States. GE Medical Systems is the world's only company with a full-field digital mammography system available to the health care community for screening and diagnosis of breast cancer.

"Throughout this approval process, the FDA has displayed big foresight and leadership in their thoughtful decision making process, while ensuring that women will have access to trusted mammography technology", stated Jeffrey R. Immelt, who is President and CEO of GE Medical Systems. "With soft copy approval, women in the United States will now benefit from the unprecedented power of digital mammography to forever improve breast care."

As part of the FDA's supplement for the pre-market approval, GE conducted a clinical trial at Northwestern University, the University of Colorado, and the University of Massachusetts. A majority of doctors involved in the trial expressed a preference for soft copy display of images, because soft copy lets them "zoom" in and enhance the images, so that they can see the difference in contrast between the lesion and surrounding tissues.

"I have interpreted over 3000 digital mammograms on soft copy, and I have no doubt that soft copy interpretations equal those from film", stated John Lewin, Assistant Professor of Radiology at the University of Colorado Health Sciences Center. "Using the workstation developed for the GE Senographe 2000D, digital mammograms can be interpreted on soft copy as quickly as on film, and the ability to magnify and adjust the image contrast and brightness adds confidence to the interpretation."

The GE Senographe 2000D has been proven to revolutionise patient care by cutting patient exam time in half, decreasing call backs, and offering better visibility of the entire breast area. The GE Senographe 2000D displays high quality patient images in just ten seconds after an exposure, providing the technologist with quick verification of correct patient positioning.

Even health care providers who have been using the GE Senographe 2000D and reading hard copy images have already benefited from an increase in productivity. They indicate that it is possible to image as many patients on one digital system as can be done on two film screen units. With soft copy approval, the providers also can eliminate film, storage and other supplies associated with film images, a substantial cost saving for all types and sizes of health care facilities.

"The approval of soft copy reading is a major breakthrough in mammography", commented Samantha Allison, General Manager of Women's Healthcare at GE Medical Systems. "The alternative imaging technologies, like Computed Tomography (CT) and Magnetic Resonance (MR), have allowed physicians to read patient images directly from an advanced workstation."

"Now for the first time ever, physicians will be able to do the same in mammography. This innovative technology will help facilities accelerate a full digital transformation which will deliver greater productivity, cost savings and excellent patient care. It is much like the significant transformation from the typewriter world to the computer age."

Already, GE has installed more than 35 systems in the United States, with 60 total installations that were expected before the end of 2000. GE has been offering the GE Senographe 2000D globally since 1999, and up till now has installed over 100 systems worldwide. More than 32.5 million mammograms are performed each year in the United States.

The technology was made available two years earlier than otherwise possible, due to GE's revolutionary Design for Six Sigma (DFSS) methodology, which is a customer-driven quality initiative for product and process development at GE. GE has invested nearly $500 million in developing its proprietary digital x-ray technology, and the company has been granted more than 100 U.S. patents.

GE Medical Systems is a $7 billion global leader in medical information and technology. Its offerings include networking and productivity tools, health care information systems, patient monitoring systems, conventional and digital x-ray, computed tomography (CT), magnetic resonance (MR), positron emission tomography (PET), ultrasound, and nuclear medicine. More details about the implementation of the Senographe 2000D system in Europe are available in the VMW November 1999 article Senographe 2000D offers new dimension in early detection of breast tumours.

Leslie Versweyveld

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