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T98-38                        Sharon Snider:       301-827-6242
June 29, 1998                 
                              Consumer Inquiries:  800-532-4440

FDA APPROVES NEW MAMMOGRAPHY SCREENING AID

FDA has approved a new computer system that will aid radiologists in reviewing mammograms by calling attention to parts of a mammogram image that are suspicious. The device has the potential to reduce the number of women who have delayed diagnosis of breast cancer due to missed abnormalities in screening mammograms. The earlier breast cancer is detected, the more likely it is to be cured.

The device, the M1000 ImageChecker, made by R2 Technology, Inc. of Los Altos, Calif., analyzes the content of mammograms and highlights suspicious areas on the images after the radiologist has done the initial evaluation.

Studies of ImageChecker showed that use of the device improved the radiologist's detection rate from approximately 80 out of 100 cancers to almost 88 out of 100.

ImageChecker scans mammograms with a laser beam to convert the image into a digital signal. The signal is processed in a high-speed computer to identify possible signs of cancer. Video monitors display the mammographic images, with markers highlighting suspicious areas.

With the ImageChecker, the radiologist first reviews the mammograms in the conventional manner, then activates ImageChecker and looks at the suspicious areas highlighted on the monitors. The radiologist then reviews those same areas on the original mammogram to see if any escaped notice and, if so, whether they require further evaluation.

In the United States, for every 80 cancers currently detected through routine mammogram screening of healthy women, an estimated 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.

FDA's approval of ImageChecker was based on data from clinical studies conducted by the manufacturer in which more than 40,000 mammograms were reviewed, and on the recommendation of the Radiological Devices Panel of FDA's Medical Devices Advisory Committee.

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