FDA has issued a warning letter to a California thermal imaging business, alleging illegal marketing and distribution of an unapproved thermography device as a sole screening tool for breast cancer and other diseases. The agency also issued a safety communication to warn patients that it has not cleared thermography as an alternative to mammography and should not replace mammography for breast cancer screening or diagnosis.
Thermography uses an infrared camera to produce images that show the patterns of heat and blood flow on or near the surface of the body. FDA has cleared it only for use alongside a primary diagnostic test like mammography, not as a standalone screening or diagnostic tool.
Total Thermal Imaging of La Mesa, Calif., markets and distributes the Thermography Business Package, an unapproved device which includes a FLIR Systems thermographic camera and proprietary software, to individuals and clinics as a sole screening tool for breast cancer and other diseases, according to FDA. Such a device would require premarket approval by the agency. 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 including breast cancer, inflammatory breast cancer, pre-stroke, heart disease, deep vein thrombosis and other diseases, an FDA statement said.
“Total Thermal Imaging Inc. is reviewing the warning letter from FDA and developing a response,” said company president and co-owner Linda Hayes in an email to Medical Design & Outsourcing. “We will work with the agency to ensure our products comply with acceptable regulations.”
FDA said there is no valid scientific data to show that thermographic 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 conditions.
“Advancing and protecting women’s health is a priority for the FDA. As part of these efforts, we will not tolerate individuals or companies who attempt to take advantage of patients by marketing unapproved devices that deceive patients and put them at risk,” said FDA commissioner Scott Gottlieb, M.D., in a prepared statement. “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. People who substitute thermography for mammography may miss the chance to detect breast cancer in its earliest and most treatable stages. We’ll continue our efforts to protect patients from those individuals or companies who ignore the FDA’s requirements intended to keep patients safe.”
The agency has issued warning letters to five other facilities since 2011 for marketing unapproved thermographic devices and/or making misleading claims about thermography.
