Digital Mammography Makes Costly Entrance
Digital Mammography Makes Costly Entrance
By Don Long
Mammography facilities this month received a belated Christmas present in the form of a new digital mammography system. And it’s no Christmas toy.
It has immediately been put into use, with prospects of challenging the current standard of film mammography, a technology that often means repeated procedures and multiple discomfort. But those advantages don’t entirely outweigh the current economics likely to slow digital’s displacement of film in this sector.
Approved in late January by the Food and Drug Administration (FDA), the Senographe 2000D signals a shift from analog to digital. Made by GE Medical Systems of Waukesha, WI, the Senographe will initially be used largely as an adjunct to traditional mammography.
Among the hospitals quickly adopting the system for use is Northwestern Memorial Hospital in Chicago, which participated in the trials leading to FDA approval, with support of $1.8 million in private funding.
Those trials required recruiting women who were willing to receive a mammogram with both systems, explains Yolanda Adler, MD, one of the Northwestern researchers.
She and other team members were given the two mammograms taken from the same individual, which they then reviewed and scored for possible lesions while also attempting to determine which mammogram was digital and which was film, Adler said.
"If we disagreed, then a third [team member] was brought in to do another reading, with all of that information then collected," Adler says.
Backing the conclusions of the clinical trial data, Adler reported that essentially no difference between the two mammograms, but, beyond that, digital offered some key advantages.
"Often, with film, you have to redo the procedure to get a clearer picture, or you need to redo it to look more closely at one part, and there is always a certain percentage where you have to do that," she said.
"With the digital mammogram, you can avoid repeating the procedure, because now you can change the contrast, blow up and magnify parts of it for a closer look." And this is particularly beneficial in diagnosing breasts characterized by dense tissue or to more closely look at areas that are suspicious or at apparent risk, she said.
Other advantages noted by Adler and the FDA in its approval are similar to those of the digital camera: computer archiving, the quick comparison of multiple images and the ability to send those images electronically to others for expert analysis.
Last year, the GE Senographe 2000D was approved for sale in Europe, Canada, Latin America, and much of Asia, and nearly 50 systems are already being used in those areas, GE said.
But the time to market maturity for digital mammography, while probably inevitable, is going to be fairly long, according to Philip Drew, PhD, an expert on medical imaging.
Digital mammography systems will initially be priced in the $500,000 range, compared to "top-end, conventional mammography systems for $80,000 or $90,000, and you can buy perfectly adequate ones for half that," he said.
Additionally, he noted that the reimbursement environment for mammography is unlikely to encourage a switch to digital by hospitals and other mammography facilities. "Because it’s a very competitive business, and because [mammography] is done quite frequently, the insurers pay minimum dollars for doing mammographic exams," Drew said, adding that in some cases it may even be a loss leader, offered primarily to create patient traffic.
"Economically speaking, it’s a marginal business, so these very expensive machines don’t have a place in a marginal business, it seems to me." (Mr. Long is Managing Editor of Medical Device Week.)
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