'One-stop shop' nears reality for advanced digital mammography

Systems offer screening, diagnosis, intervention

Workload and budgetary pressures are common in breast imaging. Little wonder mammography vendors emphasize the efficiency gains and ergonomic benefits of their digital systems.

Both GE Medical Systems and Planmed came to the European Congress of Radiology, March 5 to 9 in Vienna, with tricked-out versions of their full-field digital mammography systems. The one-stop shops for breast care-GE's Senographe DS and Planmed's Sophie Nuance-each offer a switch-in, switch-out biopsy module that supports screening, diagnostic, and interventional workup on the exact same system.

Hospitals and breast imaging clinics in Europe will get to try the Senographe DS before those in the U.S., owing to timing differences between the U.S. and European approval processes. The FDA approved the Senographe DS in February. Coincidentally, about that time, GE had identified several pilot clinical sites in Scandinavia, Germany, and France. By the start of the 2004 ECR, about half of the 10 European pilot sites had taken delivery of their systems. Nine of these sites have requested the digital stereotactic functionality, said Jean Hooks, GE's general manager of global mammography.

"The digital stereotactic capability on the Senographe DS is a big factor for our European customers, because they tend not to have enough space at their institutions to have one room for interventional procedures and one room for screening," she said. "Now they can do it all on one machine, and they have the productivity of digital workflow built in."

The Senographe DS, shown as a work-in-progress at the 2003 RSNA meeting, is the first demonstration of how GE intends to capitalize on its acquisition of Instrumentarium Imaging. GE executives were confident their technology could produce top-quality digital images, but they wanted to learn why technologists and patients preferred Instrumentarium's mammography units, Hooks said. The answer lay in smart design and ergonomic features that allowed operators to focus on their patient instead of the machine.

"It's much more intuitive than our previous systems," she said. "It has automated dose control, automated position settings, and variable speeds for the individual technologists' preferences. This makes it much easier to work with."

What GE hasn't taken from Instrumentarium, however, is that firm's views on flat-panel digital detector technology. Instrumentarium had placed its faith in amorphous selenium-based detectors, which transform x-rays directly into electrical impulses. GE is sticking with its homegrown amorphous silicon technology, which depends on a scintillator to creates flashes of light from x-rays, then converts photons to electrical signals.

"We made a decision when the two companies came together that with 800 digital mammography systems already installed worldwide, this really is the best bet for future applications," Hooks said. "Amorphous selenium does not have the inherent capabilities that amorphous silicon has."

Planmed has a different view. The Finnish company is using an amorphous selenium detector supplied by Peabody, MA-based Analogic in its new and only FFDM system. The Sophie Nuance, introduced at December's RSNA meeting, comes with an 18 x 24-cm digital detector fitted as standard. A large-area detector (24 x 30 cm), geometric magnification, and a slot-in biopsy unit are available as options.

Planmed is also developing a screen-film version of its new one-stop mammography system. The Sophie Nuance Classic, unveiled at the recent ECR, is identical to the Sophie Nuance in every way except the method of image capture. Both are fitted with Planmed's trademark MaxView technology, which maximizes the amount of breast tissue visualized during an exam.

The company is currently seeking regulatory approval for the Sophie Nuance and Sophie Nuance Classic, which are undergoing initial trials in Finland. Full-scale marketing to U.S. and European customers will begin when FDA approval and CE marking are achieved, according to Planmed.

The conventional Sophie Nuance Classic model has been designed to allow easy upgrade to FFDM should customers later decide to go digital, said Hans von Winkel, support engineer for Planmed.

"This is for departments that don't have the money to purchase a digital system yet or want to be able to make the switch when digital mammography is approved for screening work," he said.

"The cost of ownership is a huge differential between the CR full-field digital device and digital technology being offered by other vendors," Vandergrift said.