The pending FDA approval of FujiFilm’s computed radiography-based mammography system will radically change how the company approaches the U.S. market not only in CR but in PACS. Company strategists plan to position two CR products -- the single-plate reader ClearView-1m (mammography) and the multicasssette reader ClearView-CSm -- as dual-purpose devices capable of converting analog mammography systems to digital, while amplifying the capacity of and backing up already installed CR devices. Fuji will simultaneously market a mini-PACS for mammography that can be integrated with currently installed PACS, increase the capabilities of these PACS, and eventually replace them.
The pending FDA approval of FujiFilm's computed radiography-based mammography system will radically change how the company approaches the U.S. market not only in CR but in PACS. Company strategists plan to position two CR products - the single-plate reader ClearView-1m (mammography) and the multicasssette reader ClearView-CSm - as dual-purpose devices capable of converting analog mammography systems to digital, while amplifying the capacity of and backing up already installed CR devices. Fuji will simultaneously market a mini-PACS for mammography that can be integrated with currently installed PACS, increase the capabilities of these PACS, and eventually replace them.
Fuji is uniquely positioned to make this happen. The company is a major provider of enterprise-wide PACS. It is also the world leader in CR mammography, with more than 2000 units installed at sites outside the U.S, according to the firm.
Final FDA approval of its CR mammography, which could be just weeks away, will open the U.S. market to this modality. Clay Larsen, vice president of marketing and network business development at FujiFilm Medical Systems USA, expects a very warm reception.
"Full-field digital mammography has been around for five years but it has achieved only about 10% adoption in the U.S. (by mammography practitioners) because of its prohibitive price," he said. "We feel that CR mammography, when approved, is not only going to provide the highest quality of digital mammography, but it will be extremely cost-effective, being approximately half the price per room of flat-panel technology."
Demand for full-field digital mammography (FFDM) has been stoked by positive results from the DMIST (Digital Mammographic Imaging Screening Trial), published late last year, Larsen noted (DI SCAN 9/26/06, Clinical trial recommends digital over film mammography for high-risk women). Consequently, the vendors of FFDM products have enormous backlogs.
"We may very well be able to ship more quickly than those vendors, which is a kind of interesting little twist to this," he said.
Fuji plans to be all things to all mammographers, approaching sites with throughputs ranging from only a few patients a day to dozens per hour. ClearView-1m will transform a stand-alone film-based mammography system into a digital one. The single-cassette reader will deliver a digital image at about the same speed as a flat-panel digital mammography system, according to Larsen. ClearView-CSm can handle up to 20 patients per hour, he said. The company will scale its Synapse PACS to support these systems to manage whatever patient load a customer may have, laying the groundwork for future PACS expansion.
This grand strategy could be implemented very soon. Fuji announced yesterday that the FDA has issued an "Approvable Letter" for its CR mammography. The letter contains a "very short list" of information that the FDA still needs, according to Larsen.
"This information is going to be submitted very shortly, if not this week," he said. "We fully expect the final approval order before the end of June and the ability to ship 30 days after that."
If that happens, the first of Fuji's CR mammography systems could be installed and operating as early as midsummer, Larsen said.
The company's dual-side reading technology, built into its CR readers, enhances dose efficiency, according to the company, and delivers a 50-micron spatial resolution. This technology, however, was not the subject of the PMA application. Rather, the company focused on software, composed of advanced image processing tools, under the umbrella of the Fuji CR mammography suite.
By making the PMA specific to software, Fuji can now develop, enhance, and clear for market CR readers under the 510(k) process, then upgrade these readers to mammography with the FDA-approved software.
This strategy will have an immediate effect, as customers who have already purchased the ClearView-CS for radiographic applications will be able to upgrade quickly to a mammography configuration. About 80 of these systems are already operating in the U.S. The vast majority were purchased with the idea of using them initially for radiography and then upgrading to mammography on FDA approval of the software.
If all of these sites convert to mammography and Fuji can begin shipping mammography-ready CR readers by midsummer, the company could have an installed base in the hundreds by year's end.
The real payoff will come, however, if Fuji can convince sites that install its CR mammography products to buy a Synapse PACS tailored to suit the modality. These configurations will be customized to the needs of the individual sites, but they will hold the promise for customers of amplifying already installed PACS or serving as the cornerstone for a future implementation.
Fuji will leverage Synapse's proven ability to handle large data sets over multiple facilities, Larsen said. This, along with Fuji's approach to image compression, will allow mammography sites instant access to two or three years of prior mammograms, which the company will pitch as being critical to reading soft-copy mammograms.
"Because mammography will become more and more a part of the standard diagnostic process, particularly when doing correlative studies involving MR and ultrasound, mammography PACS cannot be an island," Larsen said. "This is why we feel that, in the long term, there will not be a market for mammography mini-PACS. It will be part of PACS."