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Brendon Nafziger, DOTmed News Associate Editor | December 06, 2010
Of its new products on the floor, of note was the DX-M, Agfa's mammo CR product. It's not available in the U.S. yet, as Agfa still has to get 510 (k) clearance -- but that's the interesting part.
Agfa's DX-M
(Image courtesy
Agfa Healthcare)
From DOTmed News' discussion with vendors, one of the most important announcements for RSNA actually happened well before the show. This was in early November when the U.S. Food and Drug Administration downgraded
full field digital mammography from class III, it's riskiest category, which includes most pacemakers, to class II, which includes most diagnostic imaging devices.
This opens up the U.S. market to lower-cost CR mammography products that had previously only been available in Europe. Up until now, vendors had to go through hugely expensive premarket applications, often with clinical trials, instead of filing paperwork for the quicker, cheaper 510(k) clearance for class 2 (as Agfa can do with the DX-M).
For CR mammography, this limited the field to just one vendor, Fujifilm, for almost four years, until Carestream got its mammo CR product
approved about a month ago. Now, several OEMs are expected to join the mammo CR space, and should help make digital mammography more affordable. "Watch the fun start now," one vendor joked with DOTmed News.
Agfa said DX-M is already available in most of the world outside the U.S. It's scheduled for launch in second quarter 2011, and should go for under $100,000.
McKesson: "Future Horizons Center"
DOTmed News visited McKesson's "Future Horizons Center," a section of its booth devoted to experimental products. Few professions have a workflow as measured and pressed as a radiologist's, so it's no surprise many of the offerings were focused on improving productivity.
One prototype on display was a keyboard apparatus designed with mammographers in mind.
The device, very early in the prototype phase, is now a series of white panels surrounding a keyboard. The panels each represent some common task the radiologist performs, and are outfitted with proximity sensors, so they respond when a user touches it. The hope is that radiologists can more efficiently work while staying focused on the screen. "If we can give them a piano with pedals, they would use it," said George Kovacs, director of product marketing.