by
Sean Ruck, Contributing Editor | August 07, 2014
From the July 2014 issue of HealthCare Business News magazine
Hardesty was able to get approval by pointing out the marketing foothold 3-D would deliver. “If we could be the only ones in town with the technology, we could convince patients to come to us for screening,” she says. “And we were the only ones in town with it for about a year.” That may be part of the reason why there are currently more about 1,100 3-D units installed in the U.S. — a modest number compared to 2-D digital’s 8,000 but impressive when one considers how new the technology is, how much more it costs and that there’s currently only one company providing those units.
“In the U.S. we have commercial systems in all 50 states,” Jim Culley, senior director of corporate communications at Hologic tells HCBN. “Over four million women in the U.S. will be imaged using the 3-D mammography system by our estimates.”
With Hologic being the only company currently in the U.S. market, there haven’t been the price wars seen for other modalities or technologies. “Since there’s only one on the market, you’ll probably pay $150k more for that unit than a 2-D digital mammography unit,” says ECRI’s Inamdar.
Past and present
Digital breast tomosynthesis has existed at least in theory for more than two decades. In application, it has existed for about half that time, largely due to Dr. Daniel Kopans. Kopans, a professor of radiology at Harvard Medical School, was an early advocate for breast tomosynthesis. He is also widely recognized as the father of breast tomosynthesis, holding a number of key patents regarding the technology.
Kopans realized DBT had potential much earlier than the majority of the health care sector. “I recognized the importance of being able to remove the normal breast tissue from the mammograms to see the individual planes,” he said in an email to HCBN. But the technology needed work. “All of the tomographic techniques at that time required far too much radiation, but I read about the general principles of tomosynthesis and realized its potential for breast evaluation, but I had to wait until the early 1990s because I needed digital images and computers to develop the technique,” he said.
In 1992, Kopans shared some articles on tomosynthesis with physicist colleagues and the group became part of the National Digital Mammography Development Group (NDMDG). The group helped GE and Fisher Imaging develop their prototype digital mammography systems and this led to further collaboration with GE which gave the NDMDG access to a prototype digital breast tomosynthesis detector prototype.
GE was slow to move forward with the technology in the U.S., which gave Hologic
a big opportunity. Although Hologic is currently the only domestic player, GE and Siemens have systems on the market in Europe and will likely hit the American market once they clear regulatory hurdles. Still, Hologic is not waiting for challengers before it reacts. The company released C-View software in early last year, which takes the
3-D image and reconstructs it to 2-D.
The 2-D reconstruction is important because regulatory requirements specify that both a 3-D and 2-D image have to be obtained when utilizing digital breast tomosynthesis The two scans translated to additional dose, but the reconstructive technique requires only the 3-D scan.
