FDA hits thermography vendor for selling device inappropriately

The Food and Drug Administration has issued a warning letter to a company marketing an imaging device, warning against using only it for detecting breast cancer and other diseases.

The federal agency issued the letter to Total Thermal Imaging, La Mesa, Calif., for illegally marketing and distributing the unapproved thermography device. The FDA also issued a safety communication to warn patients that thermography is not cleared by the FDA as an alternative to mammography and should not replace mammography for breast cancer screening or diagnosis.

"The FDA is concerned that patients will rely on unapproved claims that thermography may be used as a sole screening device for breast cancer and not get screened with mammography, which is proven to save lives by detecting cancer and prompting patients to seek appropriate treatment,” says FDA Commissioner Scott Gottlieb, MD.



“People who substitute thermography for mammography may miss the chance to detect breast cancer in its earliest and most treatable stages,” he added.

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Thermography is a noninvasive imaging technology 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. Thermography has been cleared by the FDA only as an “adjunctive tool,” meaning it should only be used in addition to a primary diagnostic test like mammography, not as a standalone screening or diagnostic tool.

Total Thermal Imaging markets and distributes the Thermography Business Package, an unapproved device that includes a FLIR Systems thermographic camera and proprietary software, to individuals and clinics—such a device would require premarket approval by the agency. The agency also contends that Total Thermal Imaging illegally marketed the unapproved device via a website and promotional materials claiming that its device can enable the early detection or the diagnosis of many disorders.

The agency’s warning letter asks that Total Thermal Imaging immediately cease distributing the thermography package. It also asks the firm to respond with details of how the violations noted in the warning letter will be corrected. Any violations not corrected could lead to enforcement action, such as seizure, injunction or civil money penalties.

This is not the first time the FDA has cited firms for illegally marketing and promoting thermographic devices. In a related safety communication, the FDA lists five warning letters issued to manufacturers for marketing unapproved thermographic devices or making misleading claims about thermography.