As the full-field digital mammography sector begins to warm up, several vendors are moving closer to commercialization of their own market entrees. One company, Swedish firm Sectra-Imtec, is set to begin initial testing of its MicroDose Mammography (MDM) system at St. Göran's Hospital in Stockholm this month, with other research institutions in Europe and U.S scheduled to begin formal clinical testing in early spring 2002.
Sectra is primarily known in radiology for its experience in PACS. The Linkoping-based firm has built a strong position in the Scandinavian PACS market, particularly in Sweden, and also maintains a prominent OEM relationship with Philips Medical Systems.
Sectra's foray into digital mammography has its roots from research conducted on particle physics at CERN in Geneva, Switzerland. To better visualize high-energy particles, the researchers developed new sensors that processed all of the radiation on a silicon chip, allowing for utilization of approximately 95% of x-ray emissions, according to Sectra.
Believing that the technology could be deployed beneficially for digital mammography applications, Sectra formed Mamea Imaging in 1999, a company owned jointly with several researchers from the Royal Institute of Technology in Stockholm. Mamea is spearheading the development effort for MDM, which is expected to begin general production by the end of next year.
By capturing high photon counts, MDM confers dose reduction benefits, as well as image quality enhancements, said president Torbjörn Kronander.
"According to preliminary testing, we can achieve the same image quality as conventional film-based systems, but at one-fifth the radiation exposure," he said.
And by avoiding any intermediate image processing steps such as light emission, Sectra believes that its technology best takes advantage of the inherent digital nature of x-ray radiation. The company declined to provide further technical details on the system at this time, other than to say the system produces images with a spatial resolution of 50 microns, and its detective quantum efficiency (DQE) graph reveals substantially improved performance in the high-frequency range, Kronander said.
In the U.S., Sectra will pursue the premarket approval (PMA) process with the Food and Drug Administration during 2002, and will apply only for soft-copy reading applications for the system.
"We believe that you can not utilize the benefits of digital mammography without soft- copy reading," he said.
While a final price has not yet been determined, MDM will likely be priced initially around $500,000, similar to competing systems, Kronander said. Sectra expects the price to come down as general production runs begin, however.
Of course, the stiff price of FFDM systems has been a limiting factor on the market to date. However, the economic environment for mammography varies around the world, allowing some regions to achieve break-even earlier than others, Kronander said.
"In Scandinavia, for example, mammography patient throughput is 4 to 5 times higher than in the U.S., so they have to use four to five times more film in that environment," he said. "Mammography film is expensive, so if film consumption is higher, then more money would be available for a soft-copy system."
Sectra also expects customers to be drawn by potential benefits such as telemammography. At the 2001 RSNA meeting in Chicago, Sectra will display MDM, including a stand, workstation, and miniPACS.
Down the road, Sectra may consider applying the technology to digital radiography, but not until success has been achieved in the mammography market, he said.
"The current technology is best suited for mammography, and we don't have any plans right now for the foreseeable future to adapt this to digital x-ray," he said.
Sectra will likely pursue direct sales in some countries in MDM, and is also open to distributor and OEM relationships, he said.
By Erik L. RidleyAuntMinnie.com staff writer
October 9, 2001
Related Reading
Sectra forms teleradiology services company, October 2, 2001
Sectra digital mammo system begins clinical trials, September 18, 2001
Sectra sales edge higher in first quarter, September 5, 2001
Sectra places two PACS in Swedish hospitals, June 26, 2001
Sectra posts record fiscal year, June 14, 2001
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