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The agency that approves medical devices warns people with serious medical conditions that using devices that haven't passed their standards is a risk. What a s

The agency that approves medical devices warns people with serious medical conditions that using devices that haven't passed their standards is a risk. What a shocker. 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. I am glad to have stringent standards that are upheld and enforced.

bluGill 3y ago
Approved for what? There is a difference between approved for people with and people without diabetes. If you have diabetes you may want this, but if it isn't very accurate it isn't going to do what you want. If you don't have diabetes though this could be a useful thing sitting on your watch, ready to give an alarm that you need to see a doctor because things are looking bad - people often go diagnosed with mild diabetes for a long time (depending on when their next physical is) and starting treatment for those people sooner can improve long term quality of life. Or if you do have diabetes maybe this can sometimes say do an extra blood sugar test at a time when normally you wouldn't (so long as there are not too many false positives)
- lokar 3y ago
  It would be useful and probably safe for a diabetic that is not using insulin. Even pre diabetics, just understand how your blood sugar reacts to various foods and activities is really helpful for people trying to manage the disease.
  - FireBeyond 3y ago
    If it's not accurate, it's not going to be helpful. I'm a paramedic, and for both IDDM and NIDDM patients, watching those numbers, etc., and experimenting, or "chasing the numbers" often leads to more problems than not. The issue for those patients is that hypoglycemic states are acutely problematic in a short time frame AND lead to decreased alertness, impaired judgment and decision making that can make all these things easily cascade. And when the numbers are off? It's very dicy. It's not just akin to monitoring your life metrics.
    - salad-tycoon 3y ago
      For everyone else, DM = diabetes mellitus and ID and NID = insulin dependent and non insulin dependent, as best as I can tell. Insulin dependent patients could be considered to have severe diabetes or type 1 (autoimmune/“kid” diabetes). In a nut shell. I think even something that is directionally correct could be useful for “pre diabetes “ or non diabetics. A little color coded read out instead of numbers and a general trend may help to keep the numbers at the forefront of your mind. IMO, the susceptible population that I try so hard to get them to start thinking about changing lifestyle just tend to not think about how it is affecting their health and they prefer to wait until they have “full on diabetes” requiring medication. It’s like watching a car crash in slow motion, maybe a green, yellow, red color gradient would help.
      - FireBeyond 3y ago
        You make a good point here, and yes IDDM -insulin-dependent (Type 1), NIDDM (Type 2), as you say (although for clarity - it is fairly uncommon, but possible to get adult-onset IDDM). If you were wanting to capture trends in pre-diabetics and maybe are looking at ranges, as you said, that could be a useful tool, definitely. "Lifestyle, not (directly) health". Hah, next step, watches that take your A1C blood labs (simplifying, but often used to get a good picture of average BGL over the last three months or so).
        lokar 3y ago
        The A1C helps, but there are a lot of people who for whatever reason are just not great at taking care of themselves. They don’t do any more reading/research after the Dr explains it to them, they won’t/can’t track carbs and won’t use test stops. They are really disconnected from how their body reacts to food.
renewiltord 3y ago
Tech companies are doing that. It's legacy health companies that have been trying to sell glucose monitoring watches (Masimo, etc.). Apple is not marketing their device as that because their tech is not yet ready. As usual you can count on modern tech companies to be better for everyone. Good for Apple.
- FireBeyond 3y ago
  What?? Apple fans are still bitter at Masimo, evidently. Masimo doesn't sell a glucose monitoring watch[1]. And is not trying to. The continuous health devices they do sell ARE FDA-cleared, because Masimo makes 99%+ of their revenue from selling accurate medical devices. That would be, to use a crude analogy, dangling your private parts within snapping distance of a crocodile. Your whole statement is just inaccurate and derogatory. The W1 watch doesn't do glucometry. It does heart rate and oximetry, with FDA clearance. The upcoming Freedom watch will also do hydration, pulse rate variability, respiration. And will do all of those with FDA clearance. And not glucometry. Your whole stance is not grounded in reality.
  - renewiltord 3y ago
    If you want to carry water for a predatory corporation so be it. There's a reason your comment sounds like an ad.
    - FireBeyond 3y ago
      Hah. I have an Apple Watch, basically everything Appple has released except the AVP. Pro Display, cheesegrater Pro, Studio. And you can verify that from my comment history way way back. But that doesn't mean Apple wasn't predatory here. What they did with Masimo was straight up "brain-rape" (from Silicon Valley). The $7B Masimo was "predatory" to poor $3T Apple? Hah, laughable. And to top it off, I provided factual rebuttals to your inaccurate and false assertions. So you come back with what? An ad hom that basically accuses me of being astro-turf for "legacy healthcare"? Fuck outta here.
      - 3y ago
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 ago
  That'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...

bluGill 3y ago

Approved for what? There is a difference between approved for people with and people without diabetes. If you have diabetes you may want this, but if it isn't very accurate it isn't going to do what you want. If you don't have diabetes though this could be a useful thing sitting on your watch, ready to give an alarm that you need to see a doctor because things are looking bad - people often go diagnosed with mild diabetes for a long time (depending on when their next physical is) and starting treatment for those people sooner can improve long term quality of life. Or if you do have diabetes maybe this can sometimes say do an extra blood sugar test at a time when normally you wouldn't (so long as there are not too many false positives)

lokar 3y ago
It would be useful and probably safe for a diabetic that is not using insulin. Even pre diabetics, just understand how your blood sugar reacts to various foods and activities is really helpful for people trying to manage the disease.
- FireBeyond 3y ago
  If it's not accurate, it's not going to be helpful. I'm a paramedic, and for both IDDM and NIDDM patients, watching those numbers, etc., and experimenting, or "chasing the numbers" often leads to more problems than not. The issue for those patients is that hypoglycemic states are acutely problematic in a short time frame AND lead to decreased alertness, impaired judgment and decision making that can make all these things easily cascade. And when the numbers are off? It's very dicy. It's not just akin to monitoring your life metrics.
  - salad-tycoon 3y ago
    For everyone else, DM = diabetes mellitus and ID and NID = insulin dependent and non insulin dependent, as best as I can tell. Insulin dependent patients could be considered to have severe diabetes or type 1 (autoimmune/“kid” diabetes). In a nut shell. I think even something that is directionally correct could be useful for “pre diabetes “ or non diabetics. A little color coded read out instead of numbers and a general trend may help to keep the numbers at the forefront of your mind. IMO, the susceptible population that I try so hard to get them to start thinking about changing lifestyle just tend to not think about how it is affecting their health and they prefer to wait until they have “full on diabetes” requiring medication. It’s like watching a car crash in slow motion, maybe a green, yellow, red color gradient would help.
    - FireBeyond 3y ago
      You make a good point here, and yes IDDM -insulin-dependent (Type 1), NIDDM (Type 2), as you say (although for clarity - it is fairly uncommon, but possible to get adult-onset IDDM). If you were wanting to capture trends in pre-diabetics and maybe are looking at ranges, as you said, that could be a useful tool, definitely. "Lifestyle, not (directly) health". Hah, next step, watches that take your A1C blood labs (simplifying, but often used to get a good picture of average BGL over the last three months or so).
      - lokar 3y ago
        The A1C helps, but there are a lot of people who for whatever reason are just not great at taking care of themselves. They don’t do any more reading/research after the Dr explains it to them, they won’t/can’t track carbs and won’t use test stops. They are really disconnected from how their body reacts to food.

renewiltord 3y ago

Tech companies are doing that. It's legacy health companies that have been trying to sell glucose monitoring watches (Masimo, etc.). Apple is not marketing their device as that because their tech is not yet ready. As usual you can count on modern tech companies to be better for everyone. Good for Apple.

FireBeyond 3y ago
What?? Apple fans are still bitter at Masimo, evidently. Masimo doesn't sell a glucose monitoring watch[1]. And is not trying to. The continuous health devices they do sell ARE FDA-cleared, because Masimo makes 99%+ of their revenue from selling accurate medical devices. That would be, to use a crude analogy, dangling your private parts within snapping distance of a crocodile. Your whole statement is just inaccurate and derogatory. The W1 watch doesn't do glucometry. It does heart rate and oximetry, with FDA clearance. The upcoming Freedom watch will also do hydration, pulse rate variability, respiration. And will do all of those with FDA clearance. And not glucometry. Your whole stance is not grounded in reality.
- renewiltord 3y ago
  If you want to carry water for a predatory corporation so be it. There's a reason your comment sounds like an ad.
  - FireBeyond 3y ago
    Hah. I have an Apple Watch, basically everything Appple has released except the AVP. Pro Display, cheesegrater Pro, Studio. And you can verify that from my comment history way way back. But that doesn't mean Apple wasn't predatory here. What they did with Masimo was straight up "brain-rape" (from Silicon Valley). The $7B Masimo was "predatory" to poor $3T Apple? Hah, laughable. And to top it off, I provided factual rebuttals to your inaccurate and false assertions. So you come back with what? An ad hom that basically accuses me of being astro-turf for "legacy healthcare"? Fuck outta here.
    - 3y ago

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 ago
That'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...