Here's why Apple didn't need FDA clearance for Apple Watch Series 6 blood oxygen sensing

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Comments

  • Reply 21 of 32
    StrangeDaysStrangeDays Posts: 12,879member

    This is my short video test about the precision of Apple Watch oxygen’s sensor. Its incredible for a smartwatch. I did test between it and the Masimo MightySat , for many the best product about oximeters. Clearly you have to live on correctly the Apple Watch and pay attention to don’t move during the measurements.  https://youtu.be/xg86EFsiJvQ
    So far the user reports I've read put the AW at about the same as a finger reader. AI warned against treating it as a replacement for one, but I'm not sure why yet.
  • Reply 22 of 32
    StrangeDaysStrangeDays Posts: 12,879member
    So far the implementation of the oxymeter has been a slight disappointment, in my case. Especially compared to how wonderfully something like the ECG application is implemented. Too glitchy too often, and fails to read the oxygen level 75% of the time.

    Weirdly, it needs the Watch to be somewhat loose on the hand (a "no-no" according to Apple itself, when it comes to BPM measurement, for example), and it needs to be loosened from the wrist and moved further up in the lower arm to get a clean reading. The hand also has to be PERFECTLY still, and fingers outstretched. Perhaps it's still getting used to my hand. Not the end of the world to do all this, but it's a suboptimal experience, overall.

    Hope there's a software fix of some kind, soon.
    That isn't what the Apple support page says -- it says watch should be "snug", and no mention of moving it up your arm.

    https://support.apple.com/en-us/HT211027
    razorpit
  • Reply 23 of 32
    StrangeDaysStrangeDays Posts: 12,879member
    FoodLover said:
    FoodLover said:
    This is pretty obvious given the fact that millions of Galaxy s7/8/9 and Note 8/9 with activated SpO2 measurement sensors were already sold in US in the past without an FDA certification.
    It's "pretty obvious" how FDA regulations apply to medical and health claims?  Huh.  I guess you have a different sense of intuition than us normal humans.
    What do you mean by "us"? You can speak for yourself only and not for the rest of people here.
    Maybe you just didn't like the part that others have been offering SpO2 measurement sensors for a while? Sure you didn't :D 
    He probably meant "us" people not following what the crappy knockoffs are doing. Seriously, how the hell would I know what Samsung has done prior and why would I give a shit? I'm interested in Apple products, so the fact that you knew something Samsung did earlier is completely irrelevant to me. As usual, you knockoff cheerleaders are overly concerned with "But but but first!" while the rest of us just care about things that work well. 
    tmayfastasleep
  • Reply 24 of 32
    StrangeDaysStrangeDays Posts: 12,879member

    tmay said:
    For aerobic exercise, it would be useful to be able to monitor SpO2 without that 15 second pause, and better yet, continuously, to correlate with other real time data capture like the barometer and GPS, and especially ECG. I'm guessing that isn't possible to do with the current Watch, but Apple may get there in the future.
    Even though its over 15 years old, my hospital grade SpO2 sensor takes less than 5 seconds to measure SpO2.
    I don't understand why Apple's has such a long lag time and I hope that they improve it.   But, right now, for tracking the effect of aerobic exercise on one's SoO2 level, it seems pretty worthless.   And, for me, completely worthless since it would be much quicker and easier for me to just use my own pulse ox at home.

    I can though see a benefit for somebody with impaired lung function (say from Covid or COPD) who is out and about without oxygen and this could be a way to monitor SpO2 levels while on the go.
    It's a generalist device. Of course it doesn't work as well or fast as a specialized device. That's the trade-off, of course, as this is the device you already have with you. Most people will never own a hospital-grade medical device nor carry it with them.
    fastasleep
  • Reply 25 of 32
    So far the implementation of the oxymeter has been a slight disappointment, in my case. Especially compared to how wonderfully something like the ECG application is implemented. Too glitchy too often, and fails to read the oxygen level 75% of the time.

    Weirdly, it needs the Watch to be somewhat loose on the hand (a "no-no" according to Apple itself, when it comes to BPM measurement, for example), and it needs to be loosened from the wrist and moved further up in the lower arm to get a clean reading. The hand also has to be PERFECTLY still, and fingers outstretched. Perhaps it's still getting used to my hand. Not the end of the world to do all this, but it's a suboptimal experience, overall.

    Hope there's a software fix of some kind, soon.
    That isn't what the Apple support page says -- it says watch should be "snug", and no mention of moving it up your arm.

    https://support.apple.com/en-us/HT211027
    Before reverting to your standard stance of being an Apple apologist, I suggest: (1) You read all the info in the link (which I had already looked up, thanks); (2) Try it out yourself, e.g., in an Apple store.


    MplsPgatorguybageljoey
  • Reply 26 of 32
    MplsPMplsP Posts: 3,931member
    MplsP said:
    ....
    tmay said:
    For aerobic exercise, it would be useful to be able to monitor SpO2 without that 15 second pause, and better yet, continuously, to correlate with other real time data capture like the barometer and GPS, and especially ECG. I'm guessing that isn't possible to do with the current Watch, but Apple may get there in the future.
    Pulse oximetry is often subject to motion artifact making continuous readings during exercise difficult. In addition, exercise-induced hypoxia is rare in the absence of pulmonary disease. (when you exercise, it's increased CO2 that makes you short of breath, not decreased oxygen.)

    i suspect that may depend on what type of exercise one is doing:   "moderate" vs "vigourous" vs "vigorous vigorous".  Typically those levels are measured by heart rate and its percent of its max because, well, that's the best we have while outside of a lab.

    For endurance athletes VO2Max (the ability of the body to take in oxygen, transport it to the muscles and burn it) is the primary measure of their ability.   To some degree it is heritable but mostly, for most, it is built with lots and lots of hard work.    And, while yes, it is true that the body signals to increase breathing by monitoring CO2 blood levels rather than O2 blood levels, the two go hand in hand:   as one goes up the other goes down and is mostly due to the lung's ability to clear the CO2 and oxygenate the blood.

    The process is:  the lungs oxygenate the blood while the mitochondria deoxygenate it (and replace it with carbon dioxide).   So, blood levels of O2 are important.

    Further, as demand increases beyond the ability of the blood to supply the muscles with oxygen the mitochondria shift from aerobic metabolism to anaerobic metabolism and that is an important shift for the athlete.   Aerobic metabolism can power the athlete for hours but once he shifts over into anaerobic his endurance is measured more in minutes.

    So yes, for endurance athletes, Oxygen and how much is available to the muscles in the blood is a very important measure.   One that I had hoped that Apple had provided.  And yes, it is possible to measure SpO2 on an ongoing basis during movement (you just need a secure sensor) and I'm surprised that Apple didn't do that (similar to how they measure heart rate during exercise).   I suspect that the lack of it may be due to limitations of battery life.  But, that's just a guess.

    For myself:  I had planned on buying a Series 6.  But, without a pulse ox that can measure my levels during exercise, I will wait.
    True, but when the cells switch to anaerobic metabolism, the limiting factor is almost always cellular perfusion, not blood oxygen levels. Essentially, you have cellular hypoxia, not systemic. We can debate the nuances of cellular and respiratory physiology, but the average consumer is generally not in a position to interpret such data, especially when the data is limited.

    Garmin, polar and others have devices that attempt to estimate VO2 max based on heart rate, etc. I don’t know how accurate they are, but if such algorithms can make a reasonable approximation, something like that on the Apple Watch may be useful. Who knows - maybe this will come in a watchOS update? Based on what I have read about pulse ox readings on the Apple Watch, I remain skeptical about its utility for the average consumer.
  • Reply 27 of 32
    fastasleepfastasleep Posts: 6,418member
    inotrope said:
    I wonder if Apple could* combine Pulse oximetry and ECG with the sleep app. This could be interesting in indicating a risk of Obstructive Sleep Apnoea. Indeed, add in microphone snore/apnoea sensing on the 'phone (like popular sleep tracking apps have) and this could be really useful in indicating risk - correlate with a Health App based Epworth Sleepiness Score and already entered anthropomorphic data and could identify many presently undiagnosed OSA suffers (or at least highlight a risk and prompt a physician review). It's very under diagnosed!

    *I bet they've thought of this!
    I read somewhere it does blood oxygen readings during your sleep. Mine doesn’t arrive for another week so I can’t say. 
    It does, and doesn't require any coordination with the sleep app which I don't use (still using Sleep++ for now). Just looked up my data and you can highlight all data from during periods of sleep, etc.
    I have AutoSleep as well, but have been using the Apple sleep app since release as my primary. You can keep and use both, and while AutoSleep has more data points to review, such as HR and deep sleep and noise, etc, it is also more fidgety and (by nature) more complex. Even after years of use I still have to review/correct its interpretations of when I'm sleeping. I like how Apple's sleep app just kicks in at bedtime, turns off my display for me, and can present the night's or week's sleep summary right on my Watch. 
    I tried using it for a couple days, but need to revisit and figure out if I can use it with varying sleep/wake times etc as it seems geared to people with a fixed schedule, which I don’t have. Thought I turned it off one night when I was up past my designated bedtime I had set and then still got an alarm going off on my wrist in the morning way earlier than I wanted. :) I’m sure I can figure it out, just haven’t bothered yet. 
  • Reply 28 of 32
    GeorgeBMacGeorgeBMac Posts: 11,421member

    tmay said:
    For aerobic exercise, it would be useful to be able to monitor SpO2 without that 15 second pause, and better yet, continuously, to correlate with other real time data capture like the barometer and GPS, and especially ECG. I'm guessing that isn't possible to do with the current Watch, but Apple may get there in the future.
    Even though its over 15 years old, my hospital grade SpO2 sensor takes less than 5 seconds to measure SpO2.
    I don't understand why Apple's has such a long lag time and I hope that they improve it.   But, right now, for tracking the effect of aerobic exercise on one's SoO2 level, it seems pretty worthless.   And, for me, completely worthless since it would be much quicker and easier for me to just use my own pulse ox at home.

    I can though see a benefit for somebody with impaired lung function (say from Covid or COPD) who is out and about without oxygen and this could be a way to monitor SpO2 levels while on the go.
    It's a generalist device. Of course it doesn't work as well or fast as a specialized device. That's the trade-off, of course, as this is the device you already have with you. Most people will never own a hospital-grade medical device nor carry it with them.

    I kinda thought that technology might have advanced in 15 years....
  • Reply 29 of 32
    GeorgeBMacGeorgeBMac Posts: 11,421member
    MplsP said:
    MplsP said:
    ....
    tmay said:
    For aerobic exercise, it would be useful to be able to monitor SpO2 without that 15 second pause, and better yet, continuously, to correlate with other real time data capture like the barometer and GPS, and especially ECG. I'm guessing that isn't possible to do with the current Watch, but Apple may get there in the future.
    Pulse oximetry is often subject to motion artifact making continuous readings during exercise difficult. In addition, exercise-induced hypoxia is rare in the absence of pulmonary disease. (when you exercise, it's increased CO2 that makes you short of breath, not decreased oxygen.)

    i suspect that may depend on what type of exercise one is doing:   "moderate" vs "vigourous" vs "vigorous vigorous".  Typically those levels are measured by heart rate and its percent of its max because, well, that's the best we have while outside of a lab.

    For endurance athletes VO2Max (the ability of the body to take in oxygen, transport it to the muscles and burn it) is the primary measure of their ability.   To some degree it is heritable but mostly, for most, it is built with lots and lots of hard work.    And, while yes, it is true that the body signals to increase breathing by monitoring CO2 blood levels rather than O2 blood levels, the two go hand in hand:   as one goes up the other goes down and is mostly due to the lung's ability to clear the CO2 and oxygenate the blood.

    The process is:  the lungs oxygenate the blood while the mitochondria deoxygenate it (and replace it with carbon dioxide).   So, blood levels of O2 are important.

    Further, as demand increases beyond the ability of the blood to supply the muscles with oxygen the mitochondria shift from aerobic metabolism to anaerobic metabolism and that is an important shift for the athlete.   Aerobic metabolism can power the athlete for hours but once he shifts over into anaerobic his endurance is measured more in minutes.

    So yes, for endurance athletes, Oxygen and how much is available to the muscles in the blood is a very important measure.   One that I had hoped that Apple had provided.  And yes, it is possible to measure SpO2 on an ongoing basis during movement (you just need a secure sensor) and I'm surprised that Apple didn't do that (similar to how they measure heart rate during exercise).   I suspect that the lack of it may be due to limitations of battery life.  But, that's just a guess.

    For myself:  I had planned on buying a Series 6.  But, without a pulse ox that can measure my levels during exercise, I will wait.
    True, but when the cells switch to anaerobic metabolism, the limiting factor is almost always cellular perfusion, not blood oxygen levels. Essentially, you have cellular hypoxia, not systemic. We can debate the nuances of cellular and respiratory physiology, but the average consumer is generally not in a position to interpret such data, especially when the data is limited.

    Garmin, polar and others have devices that attempt to estimate VO2 max based on heart rate, etc. I don’t know how accurate they are, but if such algorithms can make a reasonable approximation, something like that on the Apple Watch may be useful. Who knows - maybe this will come in a watchOS update? Based on what I have read about pulse ox readings on the Apple Watch, I remain skeptical about its utility for the average consumer.

    I would think that it is demand exceeding the supply that triggers the switch to anaerobic metabolism.   But maybe not.

    Apple also estimates VO2Max and, from my personal experience, I found it reasonably accurate because it was consistent with a lab measurement I got at the Cleveland Clinic after I adjust for my increased fitness since then.    There's no way for me to insure that it's accurate, but it is in the ballpark of that prior measurement and it does seem to accurately reflect my changes in fitness levels.
  • Reply 30 of 32
    bageljoeybageljoey Posts: 2,004member

    tmay said:
    For aerobic exercise, it would be useful to be able to monitor SpO2 without that 15 second pause, and better yet, contsinuously, to correlate with other real time data capture like the barometer and GPS, and especially ECG. I'm guessing that isn't possible to do with the current Watch, but Apple may get there in the future.
    Even though its over 15 years old, my hospital grade SpO2 sensor takes less than 5 seconds to measure SpO2.
    I don't understand why Apple's has such a long lag time and I hope that they improve it.   But, right now, for tracking the effect of aerobic exercise on one's SoO2 level, it seems pretty worthless.   And, for me, completely worthless since it would be much quicker and easier for me to just use my own pulse ox at home.

    I can though see a benefit for somebody with impaired lung function (say from Covid or COPD) who is out and about without oxygen and this could be a way to monitor SpO2 levels while on the go.
    It's a generalist device. Of course it doesn't work as well or fast as a specialized device. That's the trade-off, of course, as this is the device you already have with you. Most people will never own a hospital-grade medical device nor carry it with them.

    I kinda thought that technology might have advanced in 15 years....
    Fingertip devices benefit from being able to shine light through the tip of the finger.  A device on the wrist has to do a more complicated job because it cannot shine the light through.
  • Reply 31 of 32
    bageljoeybageljoey Posts: 2,004member

    fastasleep said:'
    inotrope said:
    I wonder if Apple could* combine Pulse oximetry and ECG with the sleep app. This could be interesting in indicating a risk of Obstructive Sleep Apnoea. Indeed, add in microphone snore/apnoea sensing on the 'phone (like popular sleep tracking apps have) and this could be really useful in indicating risk - correlate with a Health App based Epworth Sleepiness Score and already entered anthropomorphic data and could identify many presently undiagnosed OSA suffers (or at least highlight a risk and prompt a physician review). It's very under diagnosed!

    *I bet they've thought of this!
    I read somewhere it does blood oxygen readings during your sleep. Mine doesn’t arrive for another week so I can’t say. 
    It does, and doesn't require any coordination with the sleep app which I don't use (still using Sleep++ for now). Just looked up my data and you can highlight all data from during periods of sleep, etc.
    I have AutoSleep as well, but have been using the Apple sleep app since release as my primary. You can keep and use both, and while AutoSleep has more data points to review, such as HR and deep sleep and noise, etc, it is also more fidgety and (by nature) more complex. Even after years of use I still have to review/correct its interpretations of when I'm sleeping. I like how Apple's sleep app just kicks in at bedtime, turns off my display for me, and can present the night's or week's sleep summary right on my Watch. 
    I tried using it for a couple days, but need to revisit and figure out if I can use it with varying sleep/wake times etc as it seems geared to people with a fixed schedule, which I don’t have. Thought I turned it off one night when I was up past my designated bedtime I had set and then still got an alarm going off on my wrist in the morning way earlier than I wanted. :) I’m sure I can figure it out, just haven’t bothered yet. 
    I don’t have a regular sleep schedule either but it doesn’t seem to be a problem.  It still recognizes my sleep before (or after) my “scheduled” sleep time.  I like the automatic muting of the watch face, but if I go to bed early, I can manually tell it to start sleep mode if I want... I don’t know about the alarm issue—I set my alarms nightly for the time I want to get up, so it never goes off when it’s not supposed to.
  • Reply 32 of 32
    GeorgeBMacGeorgeBMac Posts: 11,421member
    bageljoey said:

    fastasleep said:'
    inotrope said:
    I wonder if Apple could* combine Pulse oximetry and ECG with the sleep app. This could be interesting in indicating a risk of Obstructive Sleep Apnoea. Indeed, add in microphone snore/apnoea sensing on the 'phone (like popular sleep tracking apps have) and this could be really useful in indicating risk - correlate with a Health App based Epworth Sleepiness Score and already entered anthropomorphic data and could identify many presently undiagnosed OSA suffers (or at least highlight a risk and prompt a physician review). It's very under diagnosed!

    *I bet they've thought of this!
    I read somewhere it does blood oxygen readings during your sleep. Mine doesn’t arrive for another week so I can’t say. 
    It does, and doesn't require any coordination with the sleep app which I don't use (still using Sleep++ for now). Just looked up my data and you can highlight all data from during periods of sleep, etc.
    I have AutoSleep as well, but have been using the Apple sleep app since release as my primary. You can keep and use both, and while AutoSleep has more data points to review, such as HR and deep sleep and noise, etc, it is also more fidgety and (by nature) more complex. Even after years of use I still have to review/correct its interpretations of when I'm sleeping. I like how Apple's sleep app just kicks in at bedtime, turns off my display for me, and can present the night's or week's sleep summary right on my Watch. 
    I tried using it for a couple days, but need to revisit and figure out if I can use it with varying sleep/wake times etc as it seems geared to people with a fixed schedule, which I don’t have. Thought I turned it off one night when I was up past my designated bedtime I had set and then still got an alarm going off on my wrist in the morning way earlier than I wanted. :) I’m sure I can figure it out, just haven’t bothered yet. 
    I don’t have a regular sleep schedule either but it doesn’t seem to be a problem.  It still recognizes my sleep before (or after) my “scheduled” sleep time.  I like the automatic muting of the watch face, but if I go to bed early, I can manually tell it to start sleep mode if I want... I don’t know about the alarm issue—I set my alarms nightly for the time I want to get up, so it never goes off when it’s not supposed to.

    He may have been using the alarm on the sleep schedule rather than the regular alarm.   It sounds like he should just turn that off.
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