Digital mammography is poised to make a major splash in the medical imaging market. Although studies comparing the effectiveness of digital mammography to the traditional analog equipment have yet to show a clear superiority of the new technology, practitioners are increasingly embracing the new machines, citing their perception of clearer images.
And, in spite of a price tag that can run nearly 10 times that of an analog machine, makers of full-field digital mammography systems point to increased efficiency as an aid in combating decreasing numbers of physicians and technologists that seek to serve an aging population that is sending more and more women in search of mammograms. In fact, the compliance rate of women 40 and over seeking mammograms jumped 15 percent from 1998 to 2000, according to the U.S. General Accounting Office. In 2000, 64 percent of women over 40 had a mammogram in the last year.
The advent of computer assisted detection (CAD) devices for mammography that can be coupled with digital mammography systems also increases the appeal of digital mammography to practices needing to boost productivity and accuracy in detecting breast cancers.
Currently, two companies lead the pack with full-field digital mammography systems cleared for sale by the FDA. GE Medical Systems (GEMS of Waukesha, Wis.) was the first company to gain a PMA from the FDA, followed by Fischer Imaging (Denver).
Hologic Inc. (Bedford, Mass.) is expected to be next, having received its approvable letter in July and at deadline was still awaiting notification of its GMP inspection that must happen prior to approval of the Lorad Selenia system. But hopes are that mid to late fall will bring the official launch. Hologic is currently taking orders in Europe, but hasnt yet begun installations there. Also, most users of the Lorad M-IV unit are expected to have an upgrade path to full-field digital (along with the addition of a workstation, archive and digital detector).
Please refer to the September 2002 issue for the complete story. For information on article reprints, contact Martin St. Denis