CR mammography could split digital marketplace

November 1, 2006

Fuji prepares major marketing blitz for RSNA meeting as competing vendors strategize about ways to join the fray

Fuji prepares major marketing blitz for RSNA meeting as competing vendors strategize about ways to join the fray

At first, it was easy to write off computed radiography as a digital modality. Even a decade ago, CR was old technology, widely ignored before the introduction of flat-panel digital radiography. But then vendors began touting CR as an inexpensive alternative to DR, and the fun began.

Tracing how CR established itself as a force to consider over the last 10 years involves the great common denominators of radiography itself: money and expedience. DR units, with their reliance on digital arrays manufactured by bunny-suited staff in clean rooms, were just too expensive for many buyers. CR readers allowed providers to keep using the systems they had grown to know and love. Now, with the introduction in the U.S. of CR for mammography, the question arises: Will history repeat itself?

Full-field digital mammography has had no competitors since GE Healthcare introduced the first such unit six years ago. FFDM has gained the trust and enthusiasm of women's health providers, especially after publication a year ago of the Digital Mammographic Imaging Screening Trial, which found digital mammography to be more accurate than screen-film imaging in women under 50, women who have dense breasts, and perimenopausal women.

Hologic, a bellwether for digital mammography sales, reported in July that a record number-154 to be exact-of its Selenia FFDM systems are now on back order. These numbers were tallied, however, before the FDA approved the sale of CR mammography products from Fujifilm Medical Systems USA.

Fuji estimates that although FFDM has been around for five years, it has been adopted by only about 10% of U.S. mammographers, largely because of its high price. CR mammography is not so constrained.

Andy Vandergrift, national marketing manager for women's healthcare at Fujifilm, estimates that the company can transform an established screen-film mammography site to digital for half the cost of its current competitors. A single-room mammography setup can go to digital for less than $200,000, he said. A site with up to three rooms can make the shift for less than $350,000. The actual cost will depend on the facility's particular wants or needs, as determined by the installation of data acquisition and postprocessing workstations, as well as those equipped for computer-aided detection.

"I think the marketplace will support hybrid types of situations where there will be a coexistence of CR and flat-panel mammography systems much like what we see with CR and DR in general x-ray," Vandergrift said.

In its assault on the U.S. market, Fuji plans to cover the spectrum of clinical need, offering one CR product for sites scanning only a few patients per day and another for those with high patient volumes. Both will be positioned as a dual-purpose device capable of converting an analog mammography system to digital, while serving as a backup for an already installed general-purpose CR device.

Fuji's single-plate ClearView-1m (mammography) reader will transform a stand-alone film-based mammography system into a digital one, delivering a digital image at about the same speed as a flat-panel digital mammography system, according to the company. The multicasssette ClearView-CSm reader, best suited to high-volume sites, will handle up to 20 patients per hour.

These units will be supplied mostly to fixed sites, but mobile mammography may also present an opportunity, primarily because of CR's ease of use and relatively low cost.

"CR is the ideal way to approach mobile mammography because a reader can be easily installed on a coach," Vandergrift said.

As an adjunct to its CR readers, Fuji offers a PACS optimized for mammography. The miniPACS is based on its larger enterprise-compatible Synapse system. The company is not alone in this approach. Agfa also is integrating its Impax image management system with its digital mammography platform, while offering a vendor-neutral multimodality workstation, the Impax MA 3000.

"They can display any imaging modality, instead of just mammograms or breast imaging studies," said Pat Montgomery, manager of Agfa's women's care business unit. "We can display anything that's in the PACS."

The availability of such IT add-ons will help differentiate CR competitors. Such distinctions could be necessary in less than a year.

As of early September, Kodak was completing the clinical documentation to support the FDA's review of its own submission for CR mammography. The company expects to hand this documentation to regulators before the end of this year as the third of three modules in its premarketing approval application. Stephen Archer, director of worldwide marketing for mammography solutions in the Kodak Health Group, noted that PMA submissions typically require at least 180 days for review. He is hopeful that the process will be complete in a year or so and that Kodak will be on the U.S. market with CR mammography soon after.

Agfa is also gathering clinical data but does not plan to submit them as part of a PMA application. The company expects the FDA to downgrade CR mammography, possibly within a year, to a class of medical devices that requires less rigorous review. The clinical data would be used instead to find ways to improve Agfa CR mammography; that is, if they actually are not needed for regulatory review.

"You never know," Montgomery said. "As the FDA goes through this (reclassification process), it might come out with some special controls. So having the clinical data may be valuable down the road for that purpose as well."

Getting through the FDA, however, does not mean vendors can make a beeline to widespread adoption. Other hurdles remain. Mammographers who want to go digital must be accredited through a process outlined by the FDA as part of its Mammography Quality Standards Act program. This process may take only a few days, but first an accrediting body must have a program in place for the specific product.

"Each full-field digital vendor has to go through a phase when there is no accrediting body to accredit the unit," Vandergrift said. "The American College of Radiology is now reviewing our quality control manual to determine how they will do the accreditation of our sites."

Then there is the CAD piece of the puzzle. As of early September, CAD vendors lacked FDA approval to sell their equipment for use with Fuji CR, according to Vandergrift. Obtaining this approval requires supplemental PMAs, which at press time were still pending for vendors of mammography CAD.

Finally, the sites themselves must prepare for digital mammography. This step involves training physicians and technologists, installing the software and cassettes or brand new products to support CR mammography, and integrating an archival and viewing system to handle the images.

These challenges have slowed the adoption of Fuji CR mammography. The company established a reference site at Lennox Hill Hospital in New York City just weeks after getting FDA approval but spent August in the trenches at eight other sites preparing them for a move to digital expected to be complete by the end of September. Vandergrift said he would be happy if the company had 50 sites running by the start of the RSNA meeting, even though the company has the capacity to install 30 sites per month.

Fuji is struggling with these difficulties, even though it already has a wealth of experience in CR mammography. The Japanese firm is the world leader in this area with more than 2000 units operating globally, according to company statistics. Its competitors are also well versed. Kodak has "many hundreds" of CR installations outside the U.S., according to Archer, most of them in Europe. Agfa has more than 100 CR mammography systems installed, also outside the U.S. and mostly in Europe, according to the company.

Visitors to the Kodak booth will see mammography-ready versions of the DirectView CR 850 and CR 950. The primary differences between these products equipped for mammography versus general radiography are the software and cassettes, according to Archer. Pink labeling will be unique to the mammography plates. The Total Quality Tool processing algorithm will help set the software apart.

"TQT enables a site to closely control and monitor the consistency of the images being produced on the digital system," he said.

At the RSNA meeting, Agfa plans to show its high-throughput multicassette reader CR 85-X and single-plate work-in-progress CR 35-X. The CR 85-X, launched for both mammography and general radiography outside the U.S. in 2003, is now on the U.S. market, but for general radiography only. Installed units in the U.S. can be made ready for mammography with a software upgrade. The same will be true for the CR 35-X when this unit is commercially released. Both systems will be shown in Chicago with the caveat that their use for mammography has not yet been approved by the FDA.

Fuji, the only vendor with such approval, plans a different tack. The company, which launched a marketing blitz in October for its CR mammography products, will put together an exhibit mimicking the operational use of the modality, showing how single- and multicassette readers meet the needs of different customers. It will be a welcome change from the past, Vandergrift said.

"Unlike other years, when we were on the defensive and trying to convince folks who were considering digital to wait, we will be showing people what to expect when they deploy CR mammography," he said.

Kodak and Agfa will be able to offer only assurances that they will be on the market someday. Pending changes at the FDA, however, may speed their entry. Currently CR mammography is considered a Class III device, which requires clinical results to buoy engineering claims of safety and efficacy. The FDA is planning to drop the technology to a less restrictive Class II rating, bringing it in line with the 510(k) review process that characterizes most medical imaging devices.

Montgomery and her Agfa colleagues discussed this issue with FDA officials, and they are confident that CR mammography will be downgraded to Class II. The company has gone so far as to craft a product strategy built on this anticipated change.

"We are going to leverage the decision the FDA has made to down-classify digital mammography so we can bring to market sooner the solution that the patients are demanding," Montgomery said.

Fuji is well aware of the changes afoot at the FDA, and executives there agree that the status of CR mammography will very likely be downgraded. Vandergrift said, however, that the change will take some time.

"I would be surprised if something changed prior to the end of this year or even prior to the middle of next year," he said.

Fuji, for all the effort the company put into winning approval for its CR mammography through the rigorous PMA process, would prefer that the FDA take as much time as it wants and then some.