The Apple Watch has plenty of health and fitness features. It’s long been believed that Apple has been trying to introduced blood glucose monitoring. On February 21, the FDA warned against trusting smartwatches and smart rings that claim to measure blood glucose. So, where does this leave Apple?
The safety communication issued by the FDA is specific, saying it is, “warning consumers, patients, caregivers, and health care providers of risks related to using smartwatches or smart rings that claim to measure blood glucose levels (blood sugar) without piercing the skin.”
It clarified that this is different from devices that pierce the skin and says “The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own.”
The warning comes because it believes that inaccurate blood glucose measurements could lead to mistakes in diabetes management, for instance.
If the Apple Watch ever does have blood glucose monitoring, and I believe it will, this will be done without piercing the skin. Jeff Williams, Apple’s Chief Operating Officer, talked to me about blood glucose in an interview four years ago. He did not say that Apple was going to have this in the Apple Watch, but his comments were interesting: “Non-invasive sensing of the human body is incredibly challenging. You mention glucose, people have been talking about non-invasive glucose sensing for decades. I read every year that somebody has a non-invasive glucose sensing monitor ready. And what I’ll tell you is, it’s hard enough detect glucose when you can access the interstitial fluid, it’s way harder to do it with photons.”
In other words, if Apple does it, it’s likely to be done with light, not needles, but the technology isn’t there yet.
And that’s the point. The FDA’s intervention seems to back up what Williams said, indicating that the devices on the market now are not up to it.
Dr Hon Pak, who is overseeing the development of the Samsung Galaxy Ring, told me recently that continuous measurement of glucose is one of “the goals that everyone’s trying to drive towards.”
Such a drive will surely lead to a successful product sooner or later and, if that’s Apple, it will surely apply for FDA clearance, just as it did for ECG reading on the iPhone, something that was granted literally a day before Apple announced it for the Apple Watch Series 4 in 2018. Initially it was for the U.S. only, with other health authorities deciding after that. For instance, it reached the U.K. in Spring 2019.
A similar procedure will doubtless follow for glucose monitoring, if anyone can figure out how to do it properly.
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