US FDA Warns Against Using Non-Invasive Blood Sugar Monitoring Devices Due to Lack of Accuracy

Eve Harrison

Wearables Claiming to Measure Blood Sugar Levels May Be Inaccurate, Warns US Agency.

The Food and Drug Administration (FDA) has issued a safety communication warning against using smartwatches and smart rings that claim to measure blood sugar levels without pricking the skin. These devices have not been authorized, cleared, or approved by the FDA for this purpose. Consumers, patients, and caregivers are advised to avoid these devices.

What’s Happening & Why This Matters

Currently, no consumer device is capable of non-invasive blood sugar monitoring. However, popular wearables like the Apple Watch and the Oura ring can pair with FDA-authorized wearable devices such as the Dexcom G7, which uses needles to measure blood sugar levels. The potential for a smartwatch or smart ring to monitor blood sugar levels without penetrating the skin would be a significant medical advancement, particularly for individuals with diabetes and pre-diabetics.

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Apple and Samsung have been working on this technology for years. Apple’s no-prick monitoring technology is reportedly at a “proof-of-concept stage” and may become available once the company addresses the challenge of reducing its size. Apple has been developing the project since 2010, but it is likely that it will take several years before the technology is small enough to be integrated into the Apple Watch. Additionally, Samsung is exploring ways to incorporate the technology into the Galaxy Ring, a product recently announced by the company.

t/f Summary: What’s Next

In the meantime, individuals are advised to be skeptical of any device that claims to measure blood sugar levels without pricking the skin. The FDA emphasizes that current smartwatches and smart rings do not have the capability to directly test blood glucose levels. If any company is found to be selling a device with false claims, individuals can report it to the FDA through the agency’s MedWatch Voluntary Reporting Form.

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By Eve Harrison “TF Gadget Guru”
Background:
Eve Harrison is a staff writer for TechFyle's TF Sources. With a background in consumer technology and digital marketing, Eve brings a unique perspective that balances technical expertise with user experience. She holds a degree in Information Technology and has spent several years working in digital marketing roles, focusing on tech products and services. Her experience gives her insights into consumer trends and the practical usability of tech gadgets.
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