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Smartwatch & smart ring glucose monitoring inaccurate, warns FDA

The allure of ditching the finger prick for a continuous non-invasive glucose monitor (CGM) embedded in a smartwatch or smart ring is undeniable. But the Food and Drug Administration (FDA) wants to make something very clear. Don’t trust those wearables for accurate blood sugar readings just yet.

In an advisory released Tuesday, the FDA warned against the use of smartwatches, smart rings, and other wearable devices that claim to measure blood glucose levels without drawing blood. The agency said it is aware of “growing consumer interest” in these devices. But, it has not authorized any of them for blood glucose monitoring.

“These devices have not been shown to be safe or effective for this purpose,” the FDA said in its advisory. “Using an inaccurate blood glucose measurement to make treatment decisions could have serious health consequences.”

The FDA’s warning comes as a number of tech companies, including Apple, Fitbit, and Samsung, are reportedly developing non-invasive glucose monitoring wearables. However, these devices are still in the early stages of development. And have not yet been submitted to the FDA for approval.

Innovations in non-invasive glucose monitoring

Despite the FDA’s warnings, the race to develop a non-invasive glucose monitoring device continues. Afon, a Welsh-based company, is working on Glucowear, a device that uses radio frequencies for glucose monitoring. It promises real-time, non-invasive tracking – perhaps by the end of 2024.

Similarly, Apple is reportedly developing a technology based on optical absorption spectroscopy. It aims to integrate it into future versions of the Apple Watch. These efforts reflect a broader industry trend towards making diabetes management more accessible and less invasive.

The challenge of regulatory approval

The FDA’s stance sends a clear message to the wearable tech industry. Safety and accuracy cannot be compromised, especially when it comes to managing chronic conditions like diabetes. This decision may slow the pace of innovation and market entry for new glucose monitoring technologies. However, it also emphasizes the importance of rigorous testing and regulatory oversight in ensuring that health technologies deliver on their promises without endangering users.

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This decision has implications for both the companies developing these devices and the consumers who are interested in using them. For companies, it means that they will need to invest more time and money into developing their devices and getting them approved by the FDA. For consumers, it means that they will need to be patient and wait for a safe and effective non-invasive glucose monitor to come to market.

Moving forward

The FDA’s decision is a major setback for the development of non-invasive glucose monitoring technology. But it is also a necessary step to protect public health. Inaccurate blood sugar readings can lead to serious health problems, such as diabetic ketoacidosis, a potentially life-threatening condition.

The FDA’s warning does not mean that non-invasive glucose monitoring is impossible. But it does mean that any such device must go through rigorous testing and evaluation before it can be marketed to the public.

So, if you’re looking for a continuous glucose monitor, you’ll still need to prick your finger for the foreseeable future. But the FDA’s decision is a reminder that innovation in medical technology must always be balanced with the need to protect patient safety.

It is important to note that the FDA’s warning only applies to devices that claim to measure blood glucose levels without drawing blood. There are a number of devices on the market that use other methods to measure blood glucose levels.

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Marko Maslakovic

Marko founded Gadgets & Wearables in 2014, having worked for more than 15 years in the City of London’s financial district. Since then, he has led the company’s charge to become a leading information source on health and fitness gadgets and wearables.

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