The FDA just provided what amounts to a "shout-out" to companies that design and manufacture intelligent, wearable devices that include medically-related monitoring devices and specifically, the Apple Watch 4.
Here's the link to the FDA statement: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620246.htm
And here's an interesting quote from the announcement:
... [There have come] a new swath of companies that are investing in these new opportunities [e.g., wearable, intelligent monitoring devices measuring medically-related, physiological characteristics with analysis capabilities.] These firms may be new to health care products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas. A great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch. One app creates an electrocardiogram, similar to traditional electrocardiograms, to detect the presence of atrial fibrillation and regular heart rhythm, while the other app analyzes pulse rate data to identify irregular heart rhythms suggestive of atrial fibrillation and notify the user. The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly. Health care products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health.
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I find it interesting that Dr. Gottlieb states that the Apple Watch analyzes pulse rate data, not the ECG, to detect "rhythms suggestive of atrial fibrillation." Yeah, that's a way to do it, but analysis of the ECG is a much better way. When I do a deep dive on the Apple Watch 4, I'll look into this and questions like it.
Here's the link to the FDA statement: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620246.htm
And here's an interesting quote from the announcement:
... [There have come] a new swath of companies that are investing in these new opportunities [e.g., wearable, intelligent monitoring devices measuring medically-related, physiological characteristics with analysis capabilities.] These firms may be new to health care products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas. A great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch. One app creates an electrocardiogram, similar to traditional electrocardiograms, to detect the presence of atrial fibrillation and regular heart rhythm, while the other app analyzes pulse rate data to identify irregular heart rhythms suggestive of atrial fibrillation and notify the user. The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly. Health care products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health.
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I find it interesting that Dr. Gottlieb states that the Apple Watch analyzes pulse rate data, not the ECG, to detect "rhythms suggestive of atrial fibrillation." Yeah, that's a way to do it, but analysis of the ECG is a much better way. When I do a deep dive on the Apple Watch 4, I'll look into this and questions like it.
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