FDA Approves Broader Use for CAD
The Food and Drug Administration has just given expanded its approval for the diagnostic use of a new computer-aided detection (CAD) system for evaluating suspicious areas found on screening mammograms. The ImageChecker® CAD was earlier approved by the FDA in 1998 for breast cancer screening purposes.
CAD systems scan mammograms with a laser beam and convert the image into a digital signal. The signal is then processed by a computer to identify possible signs of cancer. Video monitors display the mammographic images, with CAD markers highlighting suspicious areas.
The radiologist first reviews a mammogram in the conventional manner, then activates the CAD system and looks at any suspicious areas highlighted on the monitor. The radiologist then goes back to those same areas on the original mammogram to see if any escaped notice and, if so, whether they require further evaluation.
In 2001, approximately 34 million screening mammograms will be performed in the U.S. Studies show that for every 100,000 breast cancers currently detected by screening mammography, the use of a CAD system could result in the early detection of an additional 20,500 cancers (20.5 percent).
In addition, about 3.3 million diagnostic mammograms will be performed this year to follow-up on suspicious findings from those screening mammograms. It is estimated that for every 80 cancers currently detected through routine mammogram screening of healthy women, 20 additional cancers are missed and not found until later. Of those missed, about half have cancerous features that are simply overlooked; the other half have cancerous features but look benign.
The FDA's approval of the ImageChecker® CAD system was based on the recommendation of its Medical Devices Advisory Committee. The panel reviewed data from clinical studies conducted by the manufacturer, R2 Technology, in which more than 40,000 mammograms were evaluated in conjunction with the CAD technology.
"By expanding the approved uses of CAD, a major barrier to widespread adoption of this technology should be reduced," said R2 Technology's CEO, Mike Klein, in response to the FDA decision. "This will allow physicians to focus on detecting breast cancer at its earliest stage for the successful management and treatment of patients."
SOURCES:
The U.S. Food and Drug Administration (http://www.fda.gov)
The American Cancer Society (http://www.cancer.org)
Press statement by R2 Technology, June 13, 2001 (http://www.r2tech.com)
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