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Whether you officially list it or not, if your device is diagnosing and reporting heart attacks to people, the FDA will be involved sooner or later.


The FDA was involved in the Apple Watch.

That being said of course they will state that the watch can’t detect accurately hearth attack to avoid any liability.


And because it can’t...


If they only diagnosed but didn't report to the user but instead anonymized the data and used it for marketing would the fda care?




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