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The following is Chapter 25 of the 2006 edition of The Biomedical Engineering Handbook, Third Edition, Medical Devices and Systems published by CRC Press. Joseph D. Bronzino, editor of the handbook, comments that "Medical Devices and Systems is an authoritative reference text and is considered the "bible" of biomedical engineering. This latest volume presents new and updated material contributed by a team of world-renowned experts. The text reflects the most recent advances in both research and practice, and authoritatively covers sensor and imaging technologies, signal analysis, and medical instrumentation. This Third Edition presents an excellent summary of the status of knowledge and activities of biomedical engineers in the beginning of the 21 st century." The principle author of this chapter, Dr. William Amalu, is joined by three other worldrenowned experts in this field to present the state-of-the-art in infrared breast imaging. The following chapter contains a review of the literature along with a presentation of infrared physics, imaging system standards, a brief historical background, laboratory and patient imaging standards and protocols, and a look at the future of this lifesaving technology. The following is a brief highlight of the chapter that follows: • In 1982, the FDA approved breast thermography as an adjunctive breast cancer screening procedure. • Breast thermography has undergone extensive research since the late 1950's. • Over 30 years of research comprising over 800 peer-reviewed studies on breast thermography exist in the index-medicus literature. • In this database, well over 300,000 women have been included as study participants. • The numbers of participants in many studies are very large --10K, 37K, 60K, 85K … • Some of these studies have followed patients up to 12 years. • Strict standardized interpretation protocols have been established for over 15 years. • Breast thermography has an average sensitivity and specificity of 90%. • An abnormal thermogram is 10 times more significant as a future risk indicator for breast cancer than a first order family history of the disease. • A persistent abnormal thermogram caries with it a 22x higher risk of future breast cancer. • An abnormal infrared image is the single most important marker of high risk for developing breast cancer. • Breast thermography has the ability to detect the first signs that a cancer may be forming up to 10 years before any other procedure can detect it. • Research has shown that breast thermography significantly augments the long-term survival rates of its recipients by as much as 61%. • When used as part of a multimodal approach (clinical examination + mammography + thermography) 95% of early stage cancers will be detected. Prologue The use of infrared imaging in health care is not a recent phenomenon. Its utilization in breast cancer screening, however, is seeing renewed interest. This attention is fueled by research that clearly demonstrates the value of this procedure and the tremendous impact it has on the mortality of breast cancer. Infrared imaging of the breast has undergone extensive research since the late 1950s. Over 800 papers can be found in the indexed medical literature. In this database, well over 300,000 women have been included as study participants. The number of participants in many studies are very large and range from 10,000 to 85,000 women. Some of these studies have followed patients up to 12 years in order to establish the technology's ability as a risk marker. With strict standardized interpretation protocols having been established for over 15 years, infrared imaging of the breast has obtained an average sensitivity and specificity of 90%. As a future risk indicator for breast cancer, a persistent abnormal thermogram caries a 22 times higher risk and is 10 times more 25-2 Medical Systems and Devices significant than a first order family history of the disease. Studies clearly show that an abnormal infrared image is the single most important risk marker for the existence of or future development of breast cancer