BREAST CANCER: FDA Approves First Computerized Scanner
The Food and Drug Administration yesterday approved a computer scanner that double-checks mammograms to assure that radiologists do not miss signs of breast cancer, the Chicago Sun-Times reports. ImageChecker could diagnose 12,800 additional tumors for every 100,000 cancers detected, claims manufacturer R2 Technology Inc. (Rodriguez, 6/30). The device works by comparing digitized mammograms with a database of cancerous mammograms. "The process takes three or four minutes" (Sharpe, Wall Street Journal, 6/30). The FDA estimates that the ImageChecker could boost detection of breast cancer from 80% to 88% (Sun-Times, 6/30). According to Susan Alpert, director of the FDA's Office of Device Evaluation, "[h]aving another radiologist review mammograms led to even higher rates of detection than those achieved with the ImageChecker." The FDA also stipulated that R2 investigate whether use of the scanning device increases the rate of false-positive mammograms. Dr. Edward Sickles of the University of California at San Francisco said because "the ImageChecker costs $175,000 and requires radiologists to re-read mammograms, it may be more cost-effective just to have a second radiologist review them" (Rubin, USA Today, 6/30).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.