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FDA Cracks Down On Smartwatches Making False Claims

Jason Phillippe by Jason Phillippe
February 22, 2024
in Health News
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FDA Cracks Down On Smartwatches Making False Claims

Photo by Oliur on Unsplash

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Make sure to protect yourself from scams.

The U.S. Food and Drug Administration (FDA) has cautioned Americans managing diabetes against the use of smartwatches and smart rings that purportedly track blood sugar levels without penetrating the skin. In a recent advisory issued on Wednesday, the FDA underscored the fraudulent and potentially perilous nature of such claims.

Contrary to assertions made by sellers, these devices do not directly assess blood glucose levels through noninvasive means, as they allege. The FDA emphasized that none of these smartwatches or smart rings have received approval from the agency, and relying on them can pose serious risks.

The agency stressed that for individuals with diabetes, inaccurate blood glucose readings could result in detrimental errors in diabetes care. Such errors might involve incorrect dosages of medication, leading to dangerously low blood sugar levels.

The consequences of such errors can be severe, ranging from mental confusion to coma or even death within a matter of hours. The FDA cautioned that these unapproved devices are readily available for purchase online, manufactured by various companies and marketed under multiple brand names.

To safeguard against the risks associated with these unapproved devices, the FDA urged individuals whose medical care depends on accurate blood glucose measurements to consult with their healthcare provider about utilizing FDA-authorized devices tailored to their specific needs.

Furthermore, the FDA implored healthcare providers across the nation to alert their patients to the dangers posed by these devices. This advisory extends to all smartwatches and smart rings claiming to measure blood glucose without skin penetration, regardless of the manufacturer or brand.

In its commitment to public health and safety, the FDA reiterated its efforts to combat the illicit marketing of such devices throughout the United States. The agency’s proactive stance serves to protect individuals with diabetes from potential harm and ensure the integrity of medical devices used in managing their condition.

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