Thai FDA Warns Against Unapproved Smart Health Devices

[snoop1130]

File photo for reference only

 

The Thai Food and Drug Administration (FDA) has issued a stern warning against using Smartwatches and Smart rings for blood sugar monitoring. Leutchai Lerwut, the FDA’s Deputy Secretary-General, cautioned that these gadgets, though marketed as capable of measuring blood sugar, have not been scientifically validated.

 

With no FDA approval for these devices, Lerwut stressed the potential health risks posed by inaccurate readings leading to improper medical treatments. The FDA strongly advises consumers to rely on fingertip blood sugar monitors that comply with safety and accuracy standards.

 

 

Moreover, the FDA is pursuing legal action against entities engaging in false advertising related to these unauthorised devices. The Deputy Secretary-General encourages the public to report any suspicious medical products to the FDA hotline or through multiple channels provided for consumer protection.

 

These efforts highlight the importance of adhering to approved medical devices to ensure public health safety and prevent life-threatening mistakes in diabetes management.

 

-- 2025-01-21

 

 

[hotchilli]

Cheap stuff coming from China?

[watchcat]

At least the money dosn't go to grafty hospitals.

[WHansen]

Good advice

[tomazbodner]

 

[MikeandDow]

Take it from a diabetic, there is No, Non‐invasive blood sugar testing device  out there YET!!

[Justanotherone]

fda approved, means, they got paid, not that they will ever test safety

[MikeandDow]

Thailand do not enforce FDA approval means nothing!

[jas007]

I don't know about "unapproved" medical devices, but I'm blown away by all the different things that can be measured by my Apple Watch.  And they keep improving the software.  Th watch, along with a few different apps, monitor metrics that I have never heard of.  Anyway, they put it all together and give you a seemingly accurate analysis of your current health.  I don't think the watch can currently monitor blood sugar levels, but that may be coming in the future.    

[MikeandDow]

1 minute ago, jas007 said:

I don't know about "unapproved" medical devices, but I'm blown away by all the different things that can be measured by my Apple Watch.  And they keep improving the software.  Th watch, along with a few different apps, monitor metrics that I have never heard of.  Anyway, they put it all together and give you a seemingly accurate analysis of your current health.  I don't think the watch can currently monitor blood sugar levels, but that may be coming in the future.    

Smart watches are sold as an easy and accessible way to track your health and fitness, but even the best smart watch falls short of the accuracy required in most medical and scientific settings.

"Some of the measure and metrics of wearables can be as accurate, or inaccurate, as 50 per cent off."

its a toy!

[jas007]

34 minutes ago, MikeandDow said:

Smart watches are sold as an easy and accessible way to track your health and fitness, but even the best smart watch falls short of the accuracy required in most medical and scientific settings.

"Some of the measure and metrics of wearables can be as accurate, or inaccurate, as 50 per cent off."

its a toy!

The accuracy of metrics measured by the Apple Watch varies depending on the specific measurement being evaluated, such as heart rate, VO2Max, and calorie expenditure.
Heart Rate Measurement
The Apple Watch has demonstrated clinically acceptable accuracy for heart rate (HR) measurements, particularly during peak exercise intensity. Studies have shown that the watch’s HR measurements correlate well with gold standard ECG readings, with a mean absolute percentage error (MAPE) ranging from 6.33% to 10.69% across different activity levels. Specifically, the Apple Watch was found to have a trivial mean bias during walking and jogging, indicating that it does not significantly overestimate or underestimate HR values. In another study involving patients with abnormal heart rhythms, the Apple Watch achieved 100% accuracy within 10 beats per minute compared to ECG readings.
VO2Max Estimation
For VO2Max estimates, the Apple Watch shows a high degree of accuracy, with an error margin of about 4% from true values. A study conducted by Apple validated its cardio fitness algorithm against actual VO2Max estimates and found a reliability coefficient (ICC) between 0.86 and 0.89, indicating strong reliability in its measurements.

[MikeandDow]

13 minutes ago, jas007 said:

The accuracy of metrics measured by the Apple Watch varies depending on the specific measurement being evaluated, such as heart rate, VO2Max, and calorie expenditure.
Heart Rate Measurement
The Apple Watch has demonstrated clinically acceptable accuracy for heart rate (HR) measurements, particularly during peak exercise intensity. Studies have shown that the watch’s HR measurements correlate well with gold standard ECG readings, with a mean absolute percentage error (MAPE) ranging from 6.33% to 10.69% across different activity levels. Specifically, the Apple Watch was found to have a trivial mean bias during walking and jogging, indicating that it does not significantly overestimate or underestimate HR values. In another study involving patients with abnormal heart rhythms, the Apple Watch achieved 100% accuracy within 10 beats per minute compared to ECG readings.
VO2Max Estimation
For VO2Max estimates, the Apple Watch shows a high degree of accuracy, with an error margin of about 4% from true values. A study conducted by Apple validated its cardio fitness algorithm against actual VO2Max estimates and found a reliability coefficient (ICC) between 0.86 and 0.89, indicating strong reliability in its measurements.

"A study conducted by Apple validated its cardio fitness algorithm by apple ?? "

that should tell you enought 

 

[jas007]

2 minutes ago, MikeandDow said:

"A study conducted by Apple validated its cardio fitness algorithm by apple ?? "

that should tell you enought 

 

Apparently, it worked so well that the company that invented the O2 sensor or whatever sued Apple and won an injunction.  A ruling from the U.S. International Trade Commission (ITC) that found Apple had infringed on patents held by Masimo, a medical technology company. This ruling specifically targeted Apple’s blood oxygen monitoring technology. For a time, I think Apple stopped selling it's latest watches in the US,

 

The case was finally settled. 

[MikeandDow]

1 minute ago, jas007 said:

Apparently, it worked so well that the company that invented the O2 sensor or whatever sued Apple and won an injunction.  A ruling from the U.S. International Trade Commission (ITC) that found Apple had infringed on patents held by Masimo, a medical technology company. This ruling specifically targeted Apple’s blood oxygen monitoring technology. For a time, I think Apple stopped selling it's latest watches in the US,

 

The case was finally settled. 

They are Toys !! and not 100% accurate. and can put peoples lives at risk by giving wrong data,

[jas007]

18 minutes ago, MikeandDow said:

They are Toys !! and not 100% accurate. and can put peoples lives at risk by giving wrong data,

If you want to think that, be my guest.  All I know is that that the Apple Health Monitoring sensors and app and pretty accurate, according to everything I've read.  And there isn't a device out there that's "100%" accurate.  

 

In any event, I'm sure there may be devices you can buy that probably don't work so well.  

 

You should probably look into it sometime, if you're really all that interested.  You might be surprised.  

[MikeandDow]

22 minutes ago, jas007 said:

If you want to think that, be my guest.  All I know is that that the Apple Health Monitoring sensors and app and pretty accurate, according to everything I've read.  And there isn't a device out there that's "100%" accurate.  

 

In any event, I'm sure there may be devices you can buy that probably don't work so well.  

 

You should probably look into it sometime, if you're really all that interested.  You might be surprised.  

And thats the point of the post, how they are Not accurate for blood sugar !!  they are only indicative for heath checks and should not be realize upon.