FDA Warns Against Use of Unapproved Thermography Device for Detection of Breast Cancer

The U.S. Food and Drug Administration (FDA) issued a warning letter to Total Thermal Imaging Inc., of La Mesa, California, for illegally marketing and distributing an unapproved thermography device as a sole screening device for breast cancer. The agency also issued a warning to patients that thermography is not approved by the FDA as an alternative to mammography and should not replace mammography for breast cancer screening or diagnosis.

“People who substitute thermography for mammography may miss the chance to detect breast cancer in its earliest and most treatable stages,” said FDA Commissioner Scott Gottlieb, MD, in a statement.

Thermography Marketed as Alternative to Mammography

Thermography is a noninvasive tool that uses an infrared camera to produce images that show the patterns of heat and blood flow on or near the surface of the body, according to the FDA. It is approved as an adjunct to primary diagnostic tests, such as mammography. However, the device is being marketed as an alternative to mammography in some cases, prompting the release of the warning. The FDA said it is aware that health spas, homeopathic clinics, mobile health units, and other healthcare facilities are inappropriately using thermography as a singular tool for breast cancer screening or diagnosis.

“There is no valid scientific data to demonstrate that thermography devices, when used on their own or with another diagnostic test, are an effective screening tool for any medical condition, including the early detection of breast cancer or other diseases and health conditions,” according to the FDA. “Mammography is the most safe and effective tool for screening and diagnosis of breast cancer, and the only method proven to increase the chance of survival through earlier detection.”