R2 Technology (Sunnyvale, California) has added a big name to the list of medical manufacturers that sell its computer-aided detection system (CAD) with their digital mammography systems.
R2 reported last week that the FDA gave its approval for the company to expand the use of its ImageChecker D product for CAD processing of images acquired with the Siemens Medical Solutions (Malvern, Pennsylvania) Mammomat Novation DR and viewed on Siemens' MammoReportPlus softcopy reporting workstation.
Siemens and R2 first entered into an agreement in 2002 and renewed it earlier this year. Under that agreement, Siemens and R2 have exclusive worldwide distribution rights to sell the R2 customized product in combination with Siemens Mammomat. Worldwide shipments of the integrated systems are expected to begin "shortly," R2 said.
Julian Marshall, principal engineer with R2, told Diagnostics & Imaging Week, "This deal gives R2 access to the marketing and sales prowess of Siemens, so we're on the cusp of the wave in the U.S., and our strong relationship with them will also help bolster sales from their installed base overseas and new sales overseas."
R2 already has deals with such providers as GE Healthcare (Waukesha, Wisconsin), Fisher Healthcare (Houston) and Hologic (Bedford, Massachusetts).
Computer-aided detection is being used by more and more radiologists when reading mammograms in order to detect trouble spots that may not be seen with regular mammography.
The company said that clinical trials have demonstrated that use of the R2 ImageChecker system "could result in earlier detection of up to 23.4% of the cancers currently detected with screening mammography in those women who had a prior screening mammogram nine to 24 months earlier." R2's system was the first approved by the FDA for use with mammography, the company noted.
Now, Siemens customers "can enjoy the benefits of R2's "gold standard" CAD. As they transition to digital mammography, they're going to get the assistance of an algorithm that is designed to help the radiologists find those things that are easily overlooked" on other systems without the benefit of CAD, Marshall said.
"Siemens Medical teamed up with R2 Technology in 2002 to customize and develop innovative technology to promote women's healthcare and the early detection of breast cancer worldwide," said Holger Schmidt, head of the Special Systems Division at Siemens Medical Solutions, in a statement. "By combining our excellent products, we have created innovative solutions that improve our customer's workflow and their quality outcome."
Siemens is responsible for marketing the integrated products of R2's CAD with its Mammomat, but Schmidt said he was unsure whether the product would be introduced all at once or whether it will be rolled out. The goal is to have the Siemens/R2 product sold at one time.
Marshall told D&IW that "Siemens is the big deal here, because they already have a lot of installed systems. They're going to be aggressive, I think, in helping to deliver R2" to the marketplace.
R2's goal is to have its CAD systems sold by as many providers of digital mammography systems as possible.
Late last summer, the FDA approved the use of its competitor iCAD's (Nashua, New Hampshire) Second Look Digital CAD technology with Hologic's full-field digital mammography system the Lorad Selenia.
Last year, R2 received an FDA "approvable" letter for the ImageChecker CT CAD Software system for the purpose of detecting solid lung nodules during review of multi-detector computed tomography chest exams.
R2 said at the time that early lung cancer presents as nodules and can be difficult to detect, but the hope was that the new system could detect lung cancer earlier, leading to better outcomes.