A digital mammography system produces digital images on a solid-state receptor rather than analog images on radiographic film. Digital mammograms are performed like traditional ones, but radiologists will be able to use computers to enhance and enlarge suspicious areas or examine them from different angles. FDA approval was a long-awaited first step in using computers in even more sophisticated ways to better detect breast cancer, said Daniel Kopans, MD, director of breast imaging at Massachusetts General Hospital, Boston, who helped study the system. Although the FDA approved only the system manufactured by General Electric Medical Systems Inc., other companies are developing digital mammography machines. The FDA said the image should be considered as good as, but not better than, a traditional mammogram.
More study is needed before the company can claim better performance.
As standard mammography machines wear out, they could potentially be replaced by the new digital versions, making their use widespread. The model approved by the FDA went on the market last year in Europe, Canada, Latin America and Asia, according to the manufacturer. American women undergo some 30 million mammograms every year. Back to top.