Among the vendors vying for position in the nascent digital mammography market, Fuji Medical Systems USA has a built-in advantage: The company's technology for digital breast imaging is already incorporated into many of its computed radiography systems.
The vendor pioneered CR in the early 1980s and currently has around 10,000 systems installed around the world. For digital mammography, Fuji CR users need only change the cassettes and imaging plates in their mammography systems and have the breast imaging algorithms already in their CR readers activated by Fuji, according to William Cioffi, national marketing manager for conventional imaging systems.
"You can convert any mammography unit into a digital device," he said. "You don't even have to change the bucky."
Several hundred users around the world are employing Fuji's CR systems for digital mammography, mainly in Fuji's home market in Japan. But the mammography algorithm is currently deactivated on systems in the U.S. because it has not been approved for use by the Food and Drug Administration.
Fuji, which maintains its U.S. headquarters in Stamford, CT, has begun clinical trials in the U.S. for CR digital mammography, although it declined to specify the test locations or an expected completion date. The vendor has not decided whether to file a 510(k) application or a premarket approval (PMA) application with the FDA, and has not established a timeline for submission.
Like GE Medical Systems with its Senographe 2000D system, Fuji will likely apply for clearance initially for hard-copy applications, and submit for soft-copy clearance at a later date. Fuji plans to seek approval for both screening and diagnostic reading situations, Cioffi said.
Because facilities wouldn't need to replace their existing mammography equipment, a single CR reader with a price of $200,000 to $250,000 could support multiple mammography rooms, he said. In addition, customers could continue to read other types of x-ray studies from the system, offering further economic benefits, he said.
"What's going to make or break this technology is its cost-effectiveness," he said. "Our system can support multiple rooms and multiple types of exams."
Fuji points to its post-processing algorithms as a key benefit of CR digital mammography. For example, Fuji's dynamic range control (DRC) algorithm offers greater visibility of tissue and structures that present as very dark or very light regions on film-screen images, Cioffi said. As such, Fuji believes this allows radiologists to receive more diagnostic information compared with film-screen approaches.
Another new Fuji technology, multi-objective frequency processing (MFP), improves on DRC by adding frequency enhancement capability for multiple-sized objects, such as tumors and calcifications. Fuji has also developed a specific processing tool for mammography images, called pattern enhancement processing for mammography (PEM). In addition to being used as a regular processing algorithm for screening mammography, PEM is also deployed on Fuji's computer-aided detection (CAD) workstation and provides for searching, identifying, and evaluating microcalcification clusters.
At the 1999 RSNA meeting, Fuji highlighted what it called a works-in-progress mammography continuum. This continuum included the firm's FCR 5000R-ID CR reader, which includes specially designed algorithms to enhance breast images. It can process 115 imaging plates per hour, and can provide full-field images in sizes of 18 cm x 24 cm and 24 cm x 30 cm. In addition to 5000R-ID, all of the firm's 5000 line of readers can be used for mammography, according to the vendor.
Other elements of the mammography continuum include Fuji's internally developed CAD workstation, which the company hopes to bring to the Japanese marketplace in early 2001. QA Workstation 771 serves as the technologist's console for Fuji CR imaging plate readers, while another component of the mammography continuum, the FM-DP 2636 printer, provides hard-copy output. Fuji also described the benefits of integrating CR digital mammography with its Synapse PACS offering.
Also at the RSNA show, Fuji introduced a work-in-progress dual-side reading capability, which would allow customers to generate CR images with resolution of 50 microns and offer higher detective quantum efficiency (DQE) levels. Current systems generate images with resolution of 100 microns. Fuji expects the dual-side reading capability, which received FDA 510(k) clearance for some CR applications in February, will be utilized in mammography.
By Erik L. Ridley
AuntMinnie.com staff writer
April 18, 2000
(This is the fifth in a series of articles on digital mammography technology. Click on the headlines below to view previous articles.)
Instrumentarium to debut Diamond system in step towards full-field digital mammo. April 7, 2000
Siemens seeks to cut full-field digital mammo costs. March 24, 2000
Fischer eyes clearance for digital mammography. February 22, 2000
Digital mammography to face tough implementation hurdles. February 7, 2000
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