FDA: Thermography No Substitute for Mammograms
MONDAY, Feb. 25, 2019 — Despite claims to the contrary, thermography should not be used in place of mammography for breast cancer screening, detection, or diagnosis, according to the U.S. Food and Drug Administration.
Thermography devices — also called digital infrared imaging devices — are approved by the FDA only for use with another screening or diagnostic test like mammography, not as a stand-alone diagnostic tool. But the agency said that health spas, homeopathic clinics, mobile health units, and other health care facilities are using thermography on its own for breast cancer screening or diagnosis.
The FDA said it has “received reports that these types of facilities provide false information that can mislead patients into believing that thermography is an alternative or better option than mammography.” These inaccurate claims include statements that thermography can find breast cancer years before it would be detected through other methods or that thermography improves detection of cancer in dense breasts, the agency noted. Such claims are false or have no scientific evidence to support them, the FDA stressed.
The agency said it is taking action to stop false advertising about thermography. Last week, it issued a warning letter to one company, Total Thermal Imaging Inc., in La Mesa, California, for marketing and promoting thermography devices for uses that have not received marketing clearance or approval. The FDA has also told five other facilities to stop making inappropriate claims about thermography devices.
Posted: February 2019
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