Dive Brief:

• FDA on Monday said it warned a La Mesa, California, manufacturer it must stop distributing and marketing its unapproved thermography system as a sole screening device to detect breast cancer or other diseases because it has not been cleared as a standalone diagnostic tool.
• The agency said Total Thermal Imaging (TTI) has been illegally marketing its system, called the Thermography Business Package, as an alternative to mammography. Health spas, homeopathic clinics, mobile health units and other facilities are using the devices for that purpose.
• FDA also issued a safety communication warning patients that thermography should not replace mammography for breast cancer screening.

Dive Insight:

FDA cleared thermography in 1982 as an adjunctive tool alongside a primary diagnostic test like mammography. Use of the technology as a sole screening tool for breast cancer and other diseases would require FDA premarket approval.

But the agency, in its safety communication, noted that no scientific data exists to demonstrate that thermography, alone or with another diagnostic test, is an effective screening tool for any medical condition including breast cancer.

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

Thermography uses an infrared camera to produce images that show patterns of heat and blood flow at the surface of the body. According to the Society of Breast Imaging, the rationale behind infrared imaging is that breast cancers have increased metabolic activity that produce higher temperatures than other parts of the breast.

The radiologists' group makes clear that it does not support use of thermography either for screening or as an adjunctive tool, citing a lack of scientific evidence that thermography has any effective role in breast cancer screening.

FDA said it has a history of citing companies for illegally marketing thermographic devices or making misleading claims about the technology. In its safety communication, it provided links to five warning letters it issued to other firms marketing or making claims about the devices between 2011 and 2017.

Some facilities make inaccurate claims, such as thermography can detect breast cancer years before it would be found through other methods, or the technology improves detection in dense breasts, FDA said. TTI, the subject of the agency's latest warning letter, has asserted through its website and brochures that it offers an alternative to mammography that also looks for inflammation, lymphatic congestion and hormonal imbalances.

FDA said an inspection of the company's La Mesa facility from July 3 through Aug. 2 also revealed that the Thermography Business Package device is adulterated and does not conform with federal good manufacturing practice requirements. The device is considered misbranded because the company has failed to furnish medical device reporting information. TTI also has not met annual registration requirements for 2018 or 2019.

FDA gave TTI 15 days to correct the violations in the warning letter, noting failure to do so could lead to enforcement action such as seizure, injunction or monetary penalties.