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From the Food and Drug Administration
August 5, 1998

New Mammography Screening Aid Approved

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JAMA. 1998;280(5):410. doi:10.1001/jama.280.5.410

The FDA has approved a computer system, the first such application of an evolving technology, that identifies and marks regions of interest on routine screening mammograms to bring them to the attention of the radiologist after the initial reading has been completed. The system (M1000 ImageChecker, R2 Technology Inc, Los Altos, Calif) assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review. Data supporting the approval came from clinical studies in which more than 40000 mammograms were reviewed. Use of the device improved the detection rate from approximately 80 of 100 cancers to almost 88 of 100. The data to date do not indicate a significant increase in the false positive workup rate. Further study is to be conducted to more precisely assess the effect the device will have on true positives and on false-positive workup rates.

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