Update: FDA Approves Digital Mammography (dateline February 1, 2000)
The U.S. Food and Drug Administration (FDA) approved General Electric’s "full-field" digital mammography system on January 31, 2000. The approval comes after a recommendation from the FDA’s advisory panel in late December 1999. Studies of 635 women showed that printouts of digital mammographic images are as effective in detecting breast cancer as standard film mammograms. "This is the single biggest advance in mammography in 30 years, and women throughout the United States now have access to a powerful new tool in the fight against breast cancer," said Jeff Immelt, President and CEO of GE Medical Systems.
The advantages of digital (computerized) mammography include faster image acquisition, shorter exam, easier image storage, and physician manipulation of breast images for more accurate detection of breast cancer. Digital mammography has the potential to significantly reduce the amount of time required to acquire a mammogram from 10 to 15 minutes to less than a minute, thus providing a shorter, more comfortable exam for women. Digital images can also be manipulated to correct for under or over-exposure. If under or over-exposure occurs with a standard film-based mammography system, women have to undergo a repeat mammogram before leaving the facility.
Digital mammography is similar to standard screening mammography in that x-rays are used to produce detailed images of the breast. Full-field digital mammography uses essentially the same mammography system as conventional mammography, but instead of recording the breast image on film, a computerized image is captured with a digital receptor and displayed on a monitor. However, the FDA has currently only approved the use of printouts of digital mammogram images. "Soft copy" digital images (those that may be interpreted on the monitor) have not yet been approved.
- To learn more about the GE digital mammography system, please visit http://www.imaginis.com/breasthealth/news/news12.22.99b.asp
- The January 31, 2000 GE press release is available at http://news.excite.com/news/pr/000131/wi-ge-medical-fda