Edited to add: Everything I said here applies in theory, and may apply to the W1 sport, but I had completely missed that Masimo has a separate, not-yet-released W1 Medical watch that has in fact been FDA approved as a medical device, which is very different from saying that it has a FDA cleared SpO2 module.
Nope. It specifically says the oxygen sensor is not intended for medical use.
Perhaps we're saying the same thing but parsing it differently, but their advertisement, stated quite explicitly, is that the oxygen sensor
module is "FDA cleared":
Sport now includes FDA-cleared module for SpO2 and pulse rate
Down in the fine print, it says explicitly that the
W1 as a device is not for medical use:
Masimo W1 Sport is not a medical device.
"FDA cleared" is not quite the same thing as "intended for use as a medical device", but it's pretty close--the FDA has, if Masimo is not outright lying, determined that the module in the W1 is acceptable to use medically for measuring blood oxygen and pulse.
The difference, and the point I was trying to make, is that it doesn't matter whether the module is FDA cleared and even if that exact same sensor module is used in things that are approved medical devices--the point is that the device itself isn't FDA cleared, and there's no guarantee it's any good even if the oxygen detection technology is.
It's quite possible that when you take a module that's normally built into a clinical pulse oximetry device that clips onto a finger and integrate it into a sport watch, it just doesn't work well. It might, and maybe they'll submit this thing for FDA approval, but I wouldn't be particularly surprised if they didn't even try because they know it doesn't work that well.
One caveat is that it's not explicit as far as I can tell whether "module" in this context means the whole sensor system, just the actual sensor part, or just the part that processes the signals. So it's entirely possible that they've got medical-grade FDA-approved algorithms running on a processing module attached to a crappy wrist sensor, or a medical-grade FDA-approved optical module attached to a crappy signal processor, or even that both are medical-grade and FDA-approved.
Though even the last of the three wouldn't guarantee it works well when used on a wrist and/or without the rest of whatever a medically approved machine does.
