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Will an ongoing ban keep you from buying a future Apple Watch

  • 3

    Votes: 14 5.7%
  • Yes

    Votes: 38 15.6%
  • No

    Votes: 171 70.1%
  • Not Sure

    Votes: 21 8.6%

  • Total voters
    244
People completely misunderstand what FDA approval is and is not.

In Canada, I hate the CFIA (Canadian Food Inspection Agency) & HC (Health Canada). I would imagine that they function somewhat comparably to their US counterparts.

Tom
 
This obsession with tracking every little thing is more of a concern than helpful IMO. I get that healthcare in different parts of the world have their own issues but it feels like people are using Apple watches as a potential replacement for it. I’m all about life saving stuff like fall detection, etc, but all these federally unapproved sensors just seem like potential legal issues in the future.

Kind of feels like if you don’t have an Apple Watch then you’ll probably just die ha.
I agree and don't agree ;-)

I agree that there is an obsession with tracking of health metrics.

I think there's a bit of a misunderstanding when it comes to "federally unapproved sensors".

There are multiple pathways for health and wellness devices to legally be on the market. There are 3 common regulatory pathways, one known as premarket notification 510(k), another is premarket approval (PMA), and De Novo and each of then receive a different wording for the "FDA accepted" outcome.
  • If one goes through the 510(k) process and completes it, you get the "FDA clearance", which means you have demonstrated that your device is substantially equivalent to an existing legally marketed device.
  • If you go through the PMA route and complete it, you get "FDA approval".
  • If you go through the De Novo route (this is typically for low risk devices with no equivalent (predicate) on the market), you get "FDA granted".
There's even low risk devices (e.g., toothbrushes) where no FDA approval is really needed but the item could be FDA registered.

I believe all the Apple sensors on the watch have some type of FDA acceptance, probably FDA cleared. That is, however, a different story than patent infringement and that kind of stuff which the FDA doesn't deal with.

Also, here's a quick guide you may be interested in: https://www.greenlight.guru/blog/fda-clearance-approval-granted

Edit: Oh, there's even another route which is for mobile apps which is under FDA enforcement discretion, currently, which means for certain health apps, the FDA says it has jurisdiction but currently chooses not to apply its regulations on it.
 
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I voted not sure.
My dad (76) was recently diagnosed with pulmonary fibrosis, a degenerative scarring of lung tissue that inhibits oxygen uptake. He needs to monitor his O2 constantly and carefully. It’s undetermined if I’m (41) a likely candidate for the disease, but I’ve been more deliberate about measuring my own O2 levels since his diagnosis. Having a reliable sensor in my AW makes it easy of course, which I appreciate. But at this moment it’s nothing like a deal breaker.
 
I voted not sure.
My dad (76) was recently diagnosed with pulmonary fibrosis, a degenerative scarring of lung tissue that inhibits oxygen uptake. He needs to monitor his O2 constantly and carefully. It’s undetermined if I’m (41) a likely candidate for the disease, but I’ve been more deliberate about measuring my own O2 levels since his diagnosis. Having a reliable sensor in my AW makes it easy of course, which I appreciate. But at this moment it’s nothing like a deal breaker.
It really hits home and makes you start evaluating things like this when family involved.
 
Honestly, I'm still very happy with my AW7 at the moment. The O2 sensor was never important to me, so if Apple can't sell watches with the sensor, no biggie to me when I need to replace.
 
Strong opinion, but wrong.

What it is is a little finicky, the Watch needs to sit just right on the wrist, so you should not wear it too loosely. But when it sits right, it is quite precise.

yeah this what everyone says about all the failings with the watch and funnily enough most apple products

“you’re using it wrong”

i obviously cannot convince such a person i do wear my watch correctly
 
I just use my Apple Watch to tell the time and check my social media notifications, so the presence or lack of an oxygen sensor makes no difference at all to me. :p

Sometimes I remember about all the various fitness and health features on the Watch, and think: maybe it can tell me how many calories I burn when I walk across the street to get Taco Bell. 🌮🤪
 
yeah this what everyone says about all the failings with the watch and funnily enough most apple products

“you’re using it wrong”

i obviously cannot convince such a person i do wear my watch correctly

Just stop with the generalizations and stay on topic, will you?

It‘s just very, very obvious that the precision of a wrist-worn sensor array can be influenced by how tight or loose the device is worn. Same with tattoos negatively impacting the HR sensor.

I have obviously no idea how you wear your Watch. Maybe you do wear it tight enough but have other specific problems. Either way it‘s just wrong to claim the O2 sensor has „poor accuracy“ in general.
 
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i don’t see how that’s wrong when wearing the watch correctly gives me wildly different readings if it even manages to get a measurement

regardless there is nothing that will convince you it’s apple with a subpar sensor and watch setup
 
i don’t see how that’s wrong when wearing the watch correctly gives me wildly different readings if it even manages to get a measurement

I know you weren't directing this at me but I have to agree. It is possible that 2 people wearing the same watch will have 2 very different experiences. I don't think generalizing that it works for all or doesn't work for all is a realistic proposition and this is coming from someone who has had a great experience with the sensor (the very few times I used it).
 
i don’t see how that’s wrong when wearing the watch correctly gives me wildly different readings if it even manages to get a measurement

regardless there is nothing that will convince you it’s apple with a subpar sensor and watch setup

You just have to accept that the fact that it is (apparently) not working for you doesn‘t mean the sensor is „subpar“ as it works just fine for millions of others. If I compare to a standalone oximeter, the readings are always within 1-2%.

Maybe you want to read the results of a recent meta study: Link
 
I couldn’t care less about Massimo, they are not the ruling and governing authority.. the FDA is the ruling and governing authority and their decision is the important one.
Massimo is a manufacturer of medical devices. You know, stuff used in hospitals to make treatment decisions. You can argue that Apple's implementation is not as accurate as the Massimo one, but then that may help Apple fight the suit.

Massimo's suit has 2 parts. One is infringement of a patent. TBD how broad or narrow that patent is. The more concerning is that they want a cut of the sales because the tech was created using former Massimo employees. As a knowledge worker, that worries me. because if that claim is upheld, it could mean that a company not only owns the product you created while in their employ, but also owns any work created using knowledge and skills acquired while working for them.

Poaching employees because of their specialized knowledge has been going on forever.
 
Massimo is a manufacturer of medical devices. You know, stuff used in hospitals to make treatment decisions. You can argue that Apple's implementation is not as accurate as the Massimo one, but then that may help Apple fight the suit.

Massimo's suit has 2 parts. One is infringement of a patent. TBD how broad or narrow that patent is. The more concerning is that they want a cut of the sales because the tech was created using former Massimo employees. As a knowledge worker, that worries me. because if that claim is upheld, it could mean that a company not only owns the product you created while in their employ, but also owns any work created using knowledge and skills acquired while working for them.

Poaching employees because of their specialized knowledge has been going on forever.
Yes, I know exactly who Massimo is.. I am a medical professional who has made use of their equipment. I also know exactly who Apple is, and I am a user of their equipment.

However, my post stated that neither Massimo nor Apple are the governing authority. So, forgive me but I fail to understand the relevance of your reply.
 
The thing that surprises me is that people actually use the sensor or even ECG function. Main health functions I use is workout tracking and heart rate trend. Go to your doctor people and have a real checkup.
 
The thing that surprises me is that people actually use the sensor or even ECG function. Main health functions I use is workout tracking and heart rate trend. Go to your doctor people and have a real checkup.

Why do you think using the ECG or oximeter function means people don't go their PCP? In fact, id wager that the people that are using those functions are more likely to get their health checkup.
 
You just have to accept that the fact that it is (apparently) not working for you doesn‘t mean the sensor is „subpar“ as it works just fine for millions of others. If I compare to a standalone oximeter, the readings are always within 1-2%.

Maybe you want to read the results of a recent meta study: Link
thank you for that link.
most interesting article.
there is useful information in this.
my reading is that the Watch bridges successfully the natural divide between a lifestyle device and a medically approved device. the Watch's readings are definitely of value to me.

(a point that i noticed in the footnotes of the article however is that one of the authors has disclosed a financial relationship with apple.
quote
Footnotes
The authors have declared financial relationships, which are detailed in the next section.
Paul Windisch declare(s) personal fees from dacadoo AG. PW reports consulting for dacadoo AG, a technology company that has business activity related to Apple products.
endquote.)

but i would still tend to accept the article's research.
its well researched and annotated.
great news for apple Watch users.

if this type of "reflective" blood sensor array and its analysing software are parts of the patent infringement, apple, pls pay Masimo and settle the issue.
 
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Why do you think using the ECG or oximeter function means people don't go their PCP? In fact, id wager that the people that are using those functions are more likely to get their health checkup.
Yes! That's like saying you shouldn't have or use a thermometer and should run to the doctor, if in fact you could get an appointment in less than 3 - 6 months, if your forehead feels warm. Being able to quickly see oximeter results while you are out and about is HELPFUL in determining whether you NEED to see a doctor or not at that particular moment. But this is another case of blame the victim which is way too common these days. The main fact is that many of us purchased this expensive watch BECAUSE of things like being able to check our heart rate or O2 Sats, it was being marketed as a device that would allow you to do that. That being said I still voted not sure because I do like the watch, I like the knowledge that I can make a phone call if I need to and get help, without having a Life Alert device hanging around my neck. I understand that the ECG on the watch is useless to me because my heart throws harmless pvc's that the watch thinks are AFib, but I knew this before I bought the watch. I do go to my doctors, yes plural, some months that seems like all I do, so if I use the oximeter on my watch to give me a little reassurance in between visits that's my right.
 
It was a feature I paid for if it’s removed then I want a $100 credit
I don't think it would be removed on existing Apple Watches because they are not subject to sales ban.

What is a potential issue is non-AppleCare repairs to existing Watches. That said, I don't believe AAPL ever made a promise about how long an Apple Watch would be eligible for repair, although I nonetheless would be highly p*ssed if my AW 6, AW8, or AW Ultra 2 were considered unrepairable (completely and long-term) this soon after I purchased them.
 
If the ban is upheld and Apple is forced to remove the sensor from upcoming watch releases, would the lack of an oxygen sensor keep you from buying another Apple Watch? If so, what importance does the oxygen sensor play in your day to day health life?
N/A. I love the AW Ultra and feel no need to upgrade. When enough improvements are added I may upgrade to some future AW Ultra. Until then all the drama and the silly poll are boring.
 
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