3 ms·
> As the article says, tech companies have been able to get FDA approval for the ECGs on smart watches. Tech companies should do the same for any other medical
by FireBeyond 3y ago
> As the article says, tech companies have been able to get FDA approval for the ECGs on smart watches. Tech companies should do the same for any other medical features they want to sell.
The issue here is that the FDA has doubts that any of these devices, as they are currently, and also with some significant physiological challenges (think Theranos "this may just not be possible"), are able to do NIBGL accurately, not that "hey, just make sure you get approval, okay?"
(NIBGL - non-invasive blood glucose level)
- advisedwang 3y agoThat's just 9to5Mac's editorializing. The actual FDA article [1] reads to me like "guys' heads up that none of these are approved". I see nothing to suggest the FDA means "we will never approve one" or "we doubt the underlying technology can ever work". [1] https://www.fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication https://www.fda.gov/medical-devices/safety-communications/do...