Konica plans for mammography rely on FDA shift

There are two ways into the U.S. market for computed radiography for mammography. One path, successfully traversed by FujiFilm Medical Systems USA and now being trod by Kodak, is the FDA's premarket approval (PMA) process. But Konica Minolta is taking the road less traveled.

Efforts under way at the FDA to change CR mammography from a class 3 to a class 2 device underlie Konica Minolta's approach. This change could take a year, during which Fuji, and possibly Kodak, which last week submitted the last module of its PMA application, will have the edge. But Konica Minolta is undeterred. The company is already selling CR mammography in Japan, Europe, and Latin America and will continue to develop those markets as it waits for the U.S. regulatory agency to change course. This Agfa has adopted the same strategy.

At the RSNA meeting, Konica will display Regius Express CR for mammography as a product pending FDA review, eschewing the otherwise typical work-in-progress moniker borne by most devices awaiting the go-to-market seal of U.S. regulators.

"It is not a work-in-progress," said Eunice Lin, Konica marketing and product planning manager. "It is a released product, just not for mammography in the U.S."

The Regius Express system, currently sold in the U.S. as a general-purpose product, will require very little to upgrade for mammography. A simple software upgrade of its workstation will extend the range of its reading choices from the current resolutions of 175 microns and 87.5 microns to include 43.75 microns for mammography, according to Lin. The only other necessary changes will be the addition of special CR plates designed for mammography and a quality assurance program.

For now, Konica is chipping away at the needed work, while watching and waiting for the federal government to take action. The Federal Register must first publish a notice that the FDA has devised a guideline that explains the proposed change in regulatory status for CR mammography. It must also detail the process that vendors must follow to gain clearance to enter the U.S. market. Such a guideline typically involves 90 days for public comment.

Upon publication, the company will switch into high gear, readying efforts to file its own submission on the assumption that any comments will have only minor, if any, effects on the final guideline. The company is already preparing for the launch. It is customizing algorithms to the U.S. market and putting the finishing touches on a quality assurance program.

The most visible element of the future marketing program, however, is not in place. The company has yet to come up with a name for the U.S. product, according to Lin.

"Because we are a ways from being able to sell it, we are not as concerned about that," she said.