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FDA Goes After mHealth Devices That Claim to Replicate Mammograms

The US Food and Drug Administration has sent notices to six mHealth vendors and providers who are marketing digital health platforms that claim to be as good as mammograms in mobile health settings.

Source: ThinkStock

By Eric Wicklund

- Federal officials are taking aim at the makers of mHealth devices that aim to replicate mammograms in mobile health settings.

The US Food and Drug Administration has issued a warning letter to Total Thermal Imaging, a California-based digital health company, to stop marketing its thermography devices as a means of screening for breast cancer and other diseases. The letter is one of six issued to mHealth vendors and healthcare providers who have advertised that their devices are equivalent to a mammogram.

“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,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “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.”

Though many mobile health programs across the country that target women’s health use mammograms to screen patients for breast cancer and other health issues, some are using thermography, a process by which an infrared camera maps the patterns of heat and blood flow on or near the surface of the body. 

According to the FDA, thermography has been cleared for use as an adjunctive tool, which can be used alongside a primary test like a mammography but can’t replace that exam. Devices such as those marketed by Total Thermal Imaging (they’ve also been called digital infrared imaging devices) would first need premarket approval from the FDA.

In a separate bulletin, the FDA said it has sent five notices to “manufacturers for marketing unapproved thermographic devices and/or making misleading claims about thermography.”

“As noted in the safety communication, 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,” the FDA said. “The agency stresses that mammography is the only screening method proven to reduce deaths from breast cancer through early detection. The FDA ensures that mammography facilities follow FDA-required quality standards through the agency’s Mammography Quality Standards Act program.”


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