THERMOLOGY: SUBSTANTIATION

There are well over eight hundred peer-reviewed clinical studies on diagnostic infrared imaging for breast cancer in the Index Medicus with a data-base in excess of 300,000 women participating in these studies, often in large cohorts and some followed for up to twelve years. In 1972, Acting Secretary Thomas Tierney of the US Dept. of Health, Education and Welfare released an official position paper that stated “The medical consultants indicate that thermography, in its present state of development, is beyond the experimental stage as a diagnostic procedure in the following 4 areas: 

1. Pathology of the female breast...(2)”. 

(NOTE: the other 3 listed are not relevant to our provided services, therefore have been redacted.)


On January 29, 1982, the US Food and Drug Administration published its formal listing and classification of thermography as an adjunctive diagnostic device for breast cancer. In 2005 the FDA reaffirmed this position and classification (1). The US National Cancer Institute states “The use of thermography, also known as digital infrared imaging, is based on the principle that chemical and blood vessel activity in both precancerous and the area surrounding a developing breast cancer is almost always higher than in normal tissue. This activity frequently results in an increase in the regional surface temperature of the breast. Thermography uses ultra-sensitive infrared cameras and sophisticated computers to detect, analyze and produce high-resolution of these temperature variations, which may be among the earliest signs of breast cancer.” (2). 


There are ICD-9, ICD-10 and CPT procedure codes for breast thermology. 


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Sources

  1. Code of Federal Regulations, Title 21,  Vol. 8, 21 CFR884.2980.
  2. US NCI official website.