Report Claims iWatch Awaiting FDA Approval, Will Feature Blood Glucose and Sweat Sensors

xgman said:

So your watch can tell you you are thirsty? Boy we sure have become a lazy society.

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Some signs of dehydration are blurry vision, headache and feeling light headed. You could experience these symptoms long before you feel thirsty or if you feel thirsty at all.

This sensor (if that is the intention) would warn you to drink water BEFORE you get the symptoms above and BEFORE you feel thirsty.

Menel said:

You don't know what it looks like. What features it has. What capability it has. What the price is.

And you've reached a verdict. Impressive!

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—but if it's just an over-sized iPhone that doesn't even let you answer phone calls, it's going to be a hard sell.

This ignorance seems to make the rounds every few years. Like clockwork.

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Placing it in FDA approved "medical device land" is not as mysterious and scary as you try to make it seem. Apple has the staff to manage this. Additionally, its absolutely necessary in order to have it as a component of the dialog between patient and doctor that Apple and Mayoclinic are establishing with Health/Healthkit.

As already detailed, FDA bar for accuracy is exceptionally low.

Non-invasive glucose monitoring is probable and has been actively researched for years. Apple has the capital is buy/hire/expedite R&D

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I think you oversimplify a somewhat complex situation (background, I'm med chem). Medical device land is not so cut and dry, especially once consumer tech enters the market (and invariable mucks it up). What happens when there's multiple incidents of misreported glucose causing real medical issues? Keep in mind this isn't your regular glucose monitor that's really just an electrochemical cell with little changing on the software side -- we're talking about a phone OS (which always has software problems). The FDA doesn't do many things well, but it does triage patient safety quite well.

As far as non invasive glucose monitoring... again, not happening anytime soon, at least not as far as I'm aware. There's no portable sensors available. As I mentioned, even the most likely candidate (induced Raman) has an issue with background noise, since there's really not a signature stretch for glucose -- nothing falls in the fingerprint region. That's not even counting the size of the instrumentation currently required. There needs to be many major tech advances for this to work at all, akin to Nobel prize work.

xgman said:

So your watch can tell you you are thirsty? Boy we sure have become a lazy society.

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In my experience if you have reached the point where you are thirsty whilst exercising, you are already dehydrated. I can also say that hydration levels have the single largest effect on my capacity for exercise. I'm not saying a device is required, simply that it is an important metric when exercising and one that is not as intuitive as you might think.

I don't need a watch to give you an approximate time, but I do need one to get to meetings at precisely the right time. It's just an improvement.

Apple can not do it all. Steve Jobs said that. No company can do it all and do it great, not even Apple.

I hope there is a cure for every disease in this world, but Apple can not do it.

jacobj said:

Don't we all share a vision of the future in which you are diagnosed with an illness at the very earliest stages by some device in your home that monitors you? Was it just me?

If you share it then what type of company is going to bring it to you? Manufacturers and large scale medical equipment that have no experience in the consumer market or a company that innovates in the consumer market and has a track record of redefining normality?

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oliversl said:

Apple can not do it all. Steve Jobs said that. No company can do it all and do it great, not even Apple.

I hope there is a cure for every disease in this world, but Apple can not do it.

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Like many other large tech companies, Apple will provide devices that obtain data that's relatively easy to detect, like pulse rate. They'll leave the more complex information to other device manufacturers, at least for now. But what they will do from the get-go is aggregate all the data for the user, which is what they're aiming for with Health. With standards-based exchange of medical records, patient portals, and so on, there'll be a huge need for software to help people gather, organize, and make sense of it all.

mikethebigo said:

These leaks don't seem random or accidental. I bet Apple has finalized the design, is good to go with production, and now is starting up the hype machine.

As a medical provider, I'm actually pretty excited about the possibility of blood glucose monitoring. And at least in America, that will certainly get quite a large percentage of the population on board!

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Really? People are hankering for a blood glucose monitoring device for their wrists?

I have absolutely no interest in a watch that tells me my heartrate.

"hey look ... my bpm is 70 and a minute ago it was 65!"
"hey ... when I was DOING the set my bpm was over a 100 ... now it's settled to 75 ... how fascinating!"

I've been working out for 30 years and have never had the slightest interest in gaging sweat levels ....

I sure hope they have more up their sleeves ...

Pan321 said:

Really? People are hankering for a blood glucose monitoring device for their wrists?

I have absolutely no interest in a watch that tells me my heartrate.

"hey look ... my bpm is 70 and a minute ago it was 65!"
"hey ... when I was DOING the set my bpm was over a 100 ... now it's settled to 75 ... how fascinating!"

I've been working out for 30 years and have never had the slightest interest in gaging sweat levels ....

I sure hope they have more up their sleeves ...

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Surely you can't be so self centered to think if it's not helpful for you it's bad for a majority of people.

And yes, diabetics or people with resolved diabetes who want to make sure they're not headed back down that road would LOVE a simple, noninvasive glucose monitor.

Keep in mind, it's projected that up to 30 percent of Americans will soon be diabetic. And there are a myriad of other health issues that are addressed with electronic devices as well.

If you've been working out for a long time and are totally healthy, that's great, then you can enjoy other features of the watch, or just not get it. But for those with medical issues, it could really make a difference, really change lives.

mikethebigo said:

Surely you can't be so self centered to think if it's not helpful for you it's bad for a majority of people.



And yes, diabetics or people with resolved diabetes who want to make sure they're not headed back down that road would LOVE a simple, noninvasive glucose monitor.



Keep in mind, it's projected that up to 30 percent of Americans will soon be diabetic. And there are a myriad of other health issues that are addressed with electronic devices as well.



If you've been working out for a long time and are totally healthy, that's great, then you can enjoy other features of the watch, or just not get it. But for those with medical issues, it could really make a difference, really change lives.

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Yes.
Also more data is helpful even if you are totally healthy.
A wrist wearable that is constantly measuring your health would be fantastic.
Even if you are healthy, there might be habits to fix or form.

Pan321 said:

Really? People are hankering for a blood glucose monitoring device for their wrists?

I have absolutely no interest in a watch that tells me my heartrate.

"hey look ... my bpm is 70 and a minute ago it was 65!"
"hey ... when I was DOING the set my bpm was over a 100 ... now it's settled to 75 ... how fascinating!"

I've been working out for 30 years and have never had the slightest interest in gaging sweat levels ....

I sure hope they have more up their sleeves ...

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you should probably just buy a regular watch. Tracking your bodies vitals is probably the whole point of this thing...

mikethebigo said:

Surely you can't be so self centered to think if it's not helpful for you it's bad for a majority of people.

And yes, diabetics or people with resolved diabetes who want to make sure they're not headed back down that road would LOVE a simple, noninvasive glucose monitor.

Keep in mind, it's projected that up to 30 percent of Americans will soon be diabetic. And there are a myriad of other health issues that are addressed with electronic devices as well.

If you've been working out for a long time and are totally healthy, that's great, then you can enjoy other features of the watch, or just not get it. But for those with medical issues, it could really make a difference, really change lives.

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To misquote Andy Dufresne ... "a lot of people on macrumors are being obtuse"

New product focused on everyone who makes a phone call ... CHECK
New product focused on everyone who likes music ... CHECK
New product focused on everyone who likes to take pictures ... CHECK
New product focused on everyone worried about diabetes ..... Ummmmmm
New product focused on everyone who wants to know their sweat levels ...... Ummmmmm

Perhaps there is going to be a ton of integration between the watch and my other apple devices. I hope that is the real functionality and all the sweat monitoring is a PR diversion ....

"patient portals"

Thats a privacy nightmare Apple will be digging into in my view. GLWT

Roller said:

Like many other large tech companies, Apple will provide devices that obtain data that's relatively easy to detect, like pulse rate. They'll leave the more complex information to other device manufacturers, at least for now. But what they will do from the get-go is aggregate all the data for the user, which is what they're aiming for with Health. With standards-based exchange of medical records, patient portals, and so on, there'll be a huge need for software to help people gather, organize, and make sense of it all.

Click to expand...

Menel said:

Placing it in FDA approved "medical device land" is not as mysterious and scary as you try to make it seem. Apple has the staff to manage this. Additionally, its absolutely necessary in order to have it as a component of the dialog between patient and doctor that Apple and Mayoclinic are establishing with Health/Healthkit.

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Depends on what kind of device they're doing, of course.

If they can prove it's similar to something already on the market, then they can file a 510(k) submission with the FDA. That usually takes about five months to approve. I think we'd have seen such an application by now, though.

(I don't believe the FDA has secrecy options like the FCC does. But I don't know for sure.)

OTOH, if it's totally new hardware, then it could take several years to get approved.

So I still don't believe Apple wants to certify anything. I think they met with the FDA to get a better feel for what they could display and claim without running into trouble or needing approval.

Saw this on Twitter. No idea if it's legit. Looked up Sheri Wu on LinkedIn; MIT grad, worked as an intern at Apple in 2011.

@shewu19: insider sources tell me that the iWatch design will be a collaboration between Jony Ive and Panerai...stay tuned

Original Message:
http://twitter.com/shewu19/status/483426427732099072

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Rogifan said:

@shewu19: insider sources tell me that the iWatch design will be a collaboration between Jony Ive and Panerai...stay tuned

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Interesting. Thanks.

Looking up Panerai's history and seeing pictures of their old workshops, made me remember my own great-grandfather. He was a watchmaker for the railroad in the late 1800s. His shop was even built in the shape of the top of a grandfather clock!