GE Medical Systems earlier this month became the first company to win Food and Drug Administration approval to sell a general purpose digital mammography system.
The high-tech system, called Senographe 2000D, uses sophisticated electronics instead of film to capture images. X-ray machines for mammography are the last type of radiology equipment to use digital technology. Besides cutting film costs, the all-electronic mammography system lets clinicians manipulate images on computer screens to maximize their clinical usefulness and minimize the need for repeat exams.
The FDA had been slow to approve digital mammography systems. It rebuffed other companies, most notably Trex Medical Systems, Danbury, Conn., because it has been concerned that the digital technology could disrupt physicians' reading of mammograms, a highly subjective art.
Indeed, the FDA stipulated that doctors using GE's new mammography system make their final diagnoses from hard copies rendered by a high-resolution laser printer rather than on-screen displays.
Nevertheless, the digital mammography system will allow the creation of radiology departments that are completely film-free. But the cost, at least in the near future, would be high.
GE's medical division, based in Waukesha, Wis., said the list price for the system would be $500,000, several times higher than even top-end traditional mammography systems.
Scientific presentations on the technology have stoked clinical interest.
Joseph Stock, M.D., chairman of radiology at Crozer-Keystone Health System, Springfield, Pa., has already laid plans in his three-year capital budget to buy one of the new systems.
Patients, he said, will be attracted to digital mammography because it should cut call-back exams and detect cancer more precisely. He said that patient demand could set off a scramble by providers of mammography service to buy the new equipment.