The company that brought computed radiography to mammography is planning to add a solid-state detector to its portfolio. Fujifilm Medical Systems USA will pursue a plan that uses both approaches to address different segments of the U.S. market, according to its newly hired director of women's healthcare, Jeanine Rader.
"I think the company will be uniquely positioned to fulfill demand for full-field digital mammography," Rader said.
The underlying strategy for the sale of this still-experimental product alongside Fujifilm's CR-based system is still in the process of being finalized, according to Rader, as is the date such a system might enter the U.S. market. Company executives are deferring such questions until the RSNA meeting, when further details may be available.
Commercial development could be helped by a regulatory change now being considered by the FDA. Earlier this month, the agency announced its intention to move FFDM systems from class 3 to class 2. This would make it easier for vendors to navigate the regulatory process needed to sell digital mammography products in the U.S. This final guidance, however, will not be issued until mid-2009, according to industry estimates.
The flat-panel technology is being developed as part of a portable product. The detector will be composed of two selenium substrate layers. The first will convert x-rays into electrical signals, which will be read in the second layer through the use of an optical switch.
Fujifilm plans to produce the new selenium-based detectors in its own manufacturing plants. A novel procedure for selenium vacuum storage, developed in-house, generates extremely pure selenium layers with a consistent thickness across each one, according to the company.Preliminary tests indicate that the solid-state detector may be able to produce spatial resolution of 50 microns with improved signal-to-noise ratio over other such devices. If so, using the new detector for digital mammography may enable the operator to lower patient radiation dose while improving diagnostic confidence and the efficiency of the examination, according to the company.
The detector will be built into systems for both screening and diagnostic mammography, according to Fujifilm. The company already has thousands of CR-based FFDM systems in use outside the U.S. and about 500 operating at U.S. installations. They have become the foundation for the company's evolving women's healthcare program.
"The important piece that connects the dots is Fuji's history and capability in image processing," Rader said. "Look at our CR and digital mammography solution in the context of our Synapse PACS and our diagnostic workstation for breast imaging."
Image acquisition and management will distinguish the company in women's healthcare, said the new Fuji executive, who was recruited in early summer from U Systems, a firm focused on the development of automated breast ultrasound as an adjunct to mammography.
"It is all about image processing," she said. "Women's healthcare at Fuji aligns nicely with the company's overall corporate philosophy."
-By Greg Freiherr