The biggest change in the mammography market this year has been the arrival of the first commercially available full-field digital mammography systems in the U.S. In January GE Medical Systems leap-frogged past its competitors, becoming the first company to offer an FFDM system when the FDA approved its Senographe 2000D product.
Vendors will show further enhancements in full-field digital technology at this year's meeting. One company, Fischer Imaging, hopes to file a regulatory application shortly for its own FFDM product, SenoScan.
Other technologies to watch include computer-aided detection (CAD) workstations. Companies developing these systems hope they can be used as a back-up to radiologists by analyzing digitized mammograms and flagging suspicious areas that might need further attention. Currently only one CAD workstation is on the market in the U.S., R2 Technology's ImageChecker M1000, although systems from other companies are being sold in international markets.
CADx Medical Systems
CADx will demonstrate its Second Look CAD workstation, which uses computer algorithms to scan digitized mammograms and highlight suspicious areas for mammographers.
The current version of Second Look works with digitized films that are analyzed and then printed out to what CADx calls a Mammagraph, with suspicious regions highlighted, according to Peter Farrell, director of marketing at the Laval, Quebec company.
In its RSNA booth, CADx will highlight a new version of Second Look that analyzes data acquired directly from a full-field digital mammography system and shows results on a display monitor rather than film. CADx will demonstrate Second Look working with images collected from several different full-field digital systems, Farrell said.
CADx is selling Second Look around the world, according to Farrell. In the U.S., the company has applied for FDA approval for the first two modules of the system, and is close to submitting data for the third module, which includes data from clinical tests of the system. Second Look is being reviewed under the FDA's premarket approval (PMA) process.
Fischer Imaging
This RSNA meeting marks the commercial launch of MammoSound, which adds ultrasound guidance to Fischer Imaging's Mammotest breast biopsy table. The product was displayed at last year's meeting as a work in progress, and product sales are expected to begin in the first quarter of 2001.
MammoSound enables mammographers to use compression to stabilize the breast and scan it with the system's 10-MHz ultrasound probe. Compression makes it easier to correlate the ultrasound image with an x-ray scout image, thus supporting more accurate biopsy, according to Ken Crocker, director of marketing at the Denver company. Fischer plans to add an AutoGuide capability to the system, which will enable users to automatically move a biopsy needle into position just by pointing and clicking on the system's monitor.
On the digital mammography side, Fischer has completed a reader study in preparation for a regulatory filing for its SenoScan full-field digital mammography system. The reader study helps determine the specificity and sensitivity of SenoScan relative to film-screen mammography, Crocker said. Fischer plans to submit its regulatory filing to the Food and Drug Administration shortly.
Finally, Fischer will introduce an upgrade to the Mammotest table, called Mammotest Elite. The new version delivers higher resolution to Mammotest through the use of a new scintillating material for its CCD image acquisition camera.
GE Medical Systems
Look for the Waukesha, WI, vendor to highlight Senographe 2000D, the first (and so far the only) full-field digital mammography system to receive FDA approval. GE got the FDA's nod for the system in January.
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