CR mammography in the 21st century

October 10, 2005

The future is a murky thing, but predictions are not. Right or wrong, they leave no room for doubt, although the assumptions underlying them may be a little shaky.

The future is a murky thing, but predictions are not. Right or wrong, they leave no room for doubt, although the assumptions underlying them may be a little shaky.

A few years back, I asked an executive how many PET/CTs he expected his company to sell in the year ahead. Before answering, he asked me how many his main rival expected to sell. When I replied 200, he quickly shot back, "100 more."

So it can be with predictions. Many come from the gut or, at best, incomplete data. Over the years mine have suffered from these failings. One of the worst was a prediction, made nearly 10 years ago, that computed radiography would go the way of the buggy whip.

Digital x-ray technology, I figured, would swamp this technology by the turn of the century, and CR would serve only as a transitional technology. Boy, was I wrong. CR is doing great in radiography with no end in sight. And with its continued strength, the question has arisen about how CR will fare in mammography.

CR mammography systems are already being sold outside the U.S., and their appearance here may be only months away. Fuji appears to be in the final stages of winning FDA approval for its CR mammography technology. Other vendors are pursuing similar efforts.

With the stage set for a battle between digital and CR mammography, I should take the easy way out and avoid making any predictions whatsoever. But I feel compelled by my historical roots in this issue and another decade's experience to take a stand. So here it is.

Eventually, all mammography equipment is going to be digital. Already, vendors are raking in more revenue from the sale of full-field digital mammography equipment in this country than they are through the sale of film-based units.

Last year, the industry shipped more than 400 FFDM units to U.S. customers, accounting for about $130 million compared with about 200 units and $70 million in 2003. The shift toward digital has blunted the sale of film-based mammography units. Just 560 such systems shipped to U.S. customers in 2004, compared with 800 the year before.

If the FDA approves CR mammography, however, the growth rate for digital units will moderate. CR will extend the life of currently installed equipment while making brand new, comparatively low-cost analog alternatives to FFDM more attractive.

The rise of tomosynthesis and its extended clinical applications will make CR obsolete, but this revolution in breast imaging is years from commercial application and even longer from widespread adoption.

Look for CR mammography to boom in this country in the years after its approval by the FDA. Tens of thousands of film-based mammography systems installed across the U.S. and around the world assure CR mammography, once it has run the regulatory gantlet, of a place in clinical practice, a place it will not soon relinquish.