The FDA approves a digital mammogram machine. The Tampa cancer center has the only one of its type in Florida.
The mammogram machine in the bustling clinic at H. Lee Moffitt Cancer Center looks like any other: off-white and unassuming.
But the new digital technology it uses may help doctors find troublesome lumps more easily, while providing a crisper, more complete image of a woman's breast tissue and any masses inside.
Moffitt has the only digital mammogram machine in Florida, and one of only a handful in use in the United States. The U.S. Food and Drug Administration approved the machine on Monday, ending a long wait for Moffitt doctors here who have been studying the technique since 1996.
"The digital mammogram X-ray has higher resolution, which means it can detect smaller cancers that may not show up or be well-defined on traditional film mammography," said Dr. Martin Miller, director of radiology services at Moffitt.
The digital mammogram is conducted the same as a traditional mammogram; patients can tell no difference. But unlike with film, radiologists can use computers to enhance and enlarge suspicious areas or examine them from different angles.
The FDA specifically approved the GE Senographe 2000D, made by GE Medical Systems Inc., but other brands are being developed. The FDA said it should be considered as good as _ but not better than _ a traditional mammogram machine, which captures images on X-ray film and finds about 85 percent of cancerous lesions. More study is required before GE can claim it's better, but officials at Moffitt say digital imaging clearly provides a better picture.
Researchers at Moffitt and the National Cancer Institute say it boasts other benefits as well: Its images can be easily transmitted via computer, allowing doctors to seek opinions from specialists across the country or the world.
Eventually, technicians in the field could administer mammograms and beam the results back to radiologists at an office or hospital.
Unlike film, digital images can be banked on computer disk, saving storage space and making them easier to catalog. And with no film to develop, the results of digital mammograms are ready in minutes.
Moffitt's Senographe 2000D arrived in December. Doctors will begin using it for diagnostic exams immediately, at no additional cost, and for routine screening soon.
About 175,000 American women each year are diagnosed with breast cancer, and an estimated 43,000 died from it last year, according to the American Cancer Society.
Early detection is a key to beating it, and regular mammograms excel at detecting trouble before other symptoms develop.
The society recommends annual mammograms for women age 40 and older.
Moffitt is one of 60 National Cancer Institute treatment centers in the United States and the only one in Florida, and that agency has financed much of the development of digital mammography.
Dr. Barbara Y. Croft, program director in biomedical imaging for NCI in Bethesda, Md., said the digital image provides better contrast than film, and dense breast tissue, especially, is more easily checked.
"It's a very big step forward, there's no question about that," Croft said. "But it isn't a whole new technology or a whole new way to look at breast cancer.
"It is still an X-ray technology, and it will have all the faults that an X-ray technology has: It can't see everything."
It also is expensive.
The Senographe 2000D costs $500,000, while standard mammogram machines typically cost just under $100,000, and hospitals likely will find it difficult to recoup the costs, Croft said.
Because the FDA currently considers it no better than traditional mammography, insurance programs may not pay more for it.
And with some 12,000 mammogram machines in use nationwide, it will be years before the new ones become widespread, she said.
GE Medical Systems has told the FDA it plans to seek additional approvals as the use of the machine increases. At least three other companies are developing similar technology as well, the NCI said.
"The original (machine) has been out there for years and years, and it does a very good job of detecting cancer," FDA spokeswoman Sharon Snider said.
"Anything new that comes along, we want to make sure that it is at least as good as what's currently available."