There was a strong presence from the computer-aided detection (CAD) companies at RSNA this year with bigger booths and more scientific presentations demonstrating the advantages of CAD in breast cancer screening.
Left: GE Medical’s Senographe DMRT
CAD companies feel that when they look back on the technology’s development, 1999 will have been a breakthrough year.
The leader of the pack right now is R2 Technology Inc. (Los Altos, Calif.), which received FDA clearance on its ImageChecker system in June 1998.
R2 CEO James Pell said now that clinicians are more familiar with the technology, R2’s sales are expected to increase when the typical facility’s budgeting cycle catches up.
“Since we just started marketing at RSNA last year, [ImageChecker] isn’t in the annual budget of most facilities,” he added. “So [for the past year], the doctor who wanted this technology has had to figure out a way to get $189,000 outside the budget cycle and that’s not easy to do.”
Officials at Scanis Inc. (Foster City, Calif.) agree that 1999 has been an exciting year for CAD, although the company has yet to receive FDA clearance on its Mammex TR product.
Scanis has teamed with TRW Healthcare Solutions (Pleasanton, Calif.) for systems integration and support and gotten some strong feedback on its early trials.
“I would say the technology in the past year has moved from the benchtop to the clinic,” said Philip Kivitz, M.D., Scanis’ medical director. “We’ve done some real clinical testing with real screening populations and we’re getting a lot more information about how this product folds into the real world. I think that shows maturity for the product.”
Although not cleared for sale in the U.S., Mammex has begun shipping in Europe. Scanis CEO Robert Chapman feels the CAD technology is not dependent on the acceptance of full-field digital mammography.
If you were looking for the third CAD player at RSNA you might not have recognized it. Qualia Computing Inc. (Beavercreek, Ohio) has struck a partnership with CADx Medical Systems Inc. (Laval, Quebec, Canada), giving CADx worldwide exclusive rights to commercialize the Second Look CAD system, which Qualia developed.
According to Jim Corbett, vice president of commercial operations at CADx, the partnership was born more than a year ago when biotech firm Biochem Pharma (Laval), the parent company of CADx, decided to expand into the CAD arena.
“Qualia is the R&D team and we’re working together to get this product and future CAD-related products out,” said Corbett. “We’re going to be launching outside the U.S. in the first quarter of this year.”
CADx has repackaged the Second Look system to make the product easier to use in the hospital environment. Second Look is now a standalone system housed in a specially designed cabinet.
Shimadzu Medical Systems Inc. (Torrance, Calif.) showed a mammography system for the first time this year. Under a worldwide distribution agreement with Planmed Inc. (Wood Dale, Ill.), Shimadzu expects to sell 45 to 50 mammography units in 2000.
The YSF 128 RF is a spot filmless design and can handle an image intensifier as large as 16 inches. Shipping is set to begin this month.
Siemens Medical Systems Inc. (Iselin, N.J.) introduced its Mammomat 3000 Nova mammography system, a detector system designed to produce optimal images for a variety of breast types and sizes at the lowest dose.
The Mammomat 3000 Nova features an automatic exposure control system recently designed to meet the requirements of today’s film/screen combinations. In addition, new biopsy paddles can widen users’ magnification choices.
The biopsy paddles also are used with Siemens’ optional Opdima digital spot imaging system upgrade, which equips the Mammomat 3000 Nova with high detector resolution.
The Mammomat 1000 screening system, also introduced at RSNA, rounds out Siemens’ line of women’s healthcare medical imaging systems. Options for the Mammomat 1000 include dual hand-held controls that allow for remote angulation of tube-head and C-arm height adjustment, as well as Opdima digital spot imaging.
GE Medical Systems (GEMS of Waukesha, Wis.) offerings include a new advanced mammography system, the GE Senographe DMR+.
Available globally, the system uses specially designed MaxiRay X-ray tubes to enhance images during the first exam with 40 percent less radiation over previous tubes.
GEMS’ Senographe 2000D full-field digital mammography product is awaiting FDA clearance. On Dec. 16, two weeks after RSNA, GEMS received word that the FDA’s Radiology Device Advisory Panel voted to recommend clearance of the Senographe 2000D full-field digital mammography system for hard-copy image reading.
A separate clearance is required before Senographe 2000D’s images can used for soft-copy diagnosis, but GEMS said the FDA has agreed to expedite the review of the soft-copy process. 
