BY STEVEN K. WAGNER

Only GE Medical Systems markets a full-field digital mammography system in the U.S., but Fischer Imaging received an approvable letter from the FDA in July regarding its SenoScan system. Final approval to begin marketing it was expected to follow within a few months.

"SenoScan provides many advantages over film-screen mammography," said Ken Crocker, director of marketing for Fischer. "Images acquired in seconds in our digital format allow the radiologist immediate control over contrast and brightness levels and thus provide improved visualization of the entire breast."

CADx Medical Systems continues to guide its Second Look computer-aided detection system through the FDA. The system, which assists radiologists in the early detection of breast cancer, is not yet cleared for marketing in the U.S. Second Look provides a computerized second review that draws radiologists' attention to suspicious microcalcifications and masses.

The jury is still out on CAD, said Dr. R. James Brenner, chief of breast imaging at the Joyce Eisenberg Keefer Breast Center in Santa Monica, CA.

"The methodology used in preliminary studies comparing CAD-detected cancers not diagnosed in prior years does not reveal whether a radiologist did not detect a lesion, or saw it and elected not to recall it," he said. "If the problem with so-called false negatives emerging from these studies is the former, then CAD as a detection aid provides a kind of safety net. If radiologists are not recalling some of these lesions because they are detected but not considered above an appropriate threshold level for recall or biopsy, CAD as a detection aid may have less impact."

Not all breast imaging advances depend on traditional mammography. In June, Computerized Thermal Imaging submitted the final module of its premarket approval application to the FDA for a thermal imaging system that helps doctors differentiate between benign and malignant breast lesions. The system is noninvasive, painless, and requires no radiation, breast compression, or electric current. It works by analyzing more than 8.3 million temperature values to measure minute changes in physiological and metabolic activity.