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Rumor: Apple's 'iWatch' team grows to 200 people, device won't be regulated by FDA

post #1 of 28
Thread Starter 
Rumors about a future wrist-worn smart device from Apple continue to emerge, with one report Monday claiming the team in Cupertino, Calif., working on the so-called "iWatch" has grown to include more than 200 people.

iWatch
iWatch concept by Todd Hamilton




Citing unnamed sources with "limited but direct knowledge" of the rumored device, MobiHealthNews claims that the "iWatch" will be a peripheral device, dependent upon connectivity to an iPhone for users to gain full functionality. The technological capabilities of the rumored device were also said to be "simpler" than some have hoped, and won't have sensors for rumored advanced functions such as glucose sensing and hydration tracking. Monday's report was highlighted by NetworkWorld.

Because the device isn't expected to have such advanced sensors, the wrist-worn accessory is not expected to be regulated by the U.S. Food and Drug Administration, according to the report. Apple officials are said to have recently met with the FDA to ensure that the device won't come under the umbrella of the administration's new guidance for mobile medical apps.

The report also threw more weight behind rumors of a "Healthbook" application for iOS, which would apparently communicate with the "iWatch" to track and share health data for users. To that end, Apple is said to be focusing on the "experience" of the device, rather than the technology behind it.

Potential areas of interest for the rumored "Healthbook" application identified by MobiHealthNews include exercise, sleep, stress, reminders for taking medication, and potentially women's health data related to pregnancy.

The source of Monday's rumor does not have an established track record with regard to rumors about future Apple products. However, the same site was the first to reveal last month that Michael O'Reilly, former chief medical officer and executive vice president of medical affairs at pulse oximeter firm Masimo Corporation, was hired by Apple.

O'Reilly was said to have been joined by Apple SVP of Operations Jeff Williams, VP of software and Technology Bud Tribble, and government affairs counsel Tim Powderly in a meeting with the FDA in December to discuss "mobile medical applications." It's widely believed that Apple's interest in medical and health issues could be tied to its work on a so-called "iWatch" accessory.
post #2 of 28

Looking forward to seeing the Apple Wrist-Top.

Probably won't buy one though.

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post #3 of 28
Quote:
Citing unnamed sources with "limited but direct knowledge" of the rumored device.

That is one funny sentence. Citing unnamed sources with limited but direct knowledge of a rumoured device.

Comedy insider.

Time to adjust me signature.
Edited by Ireland - 2/10/14 at 12:55pm
Citing unnamed sources with limited but direct knowledge of the rumoured device - Comedy Insider (Feb 2014)
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Citing unnamed sources with limited but direct knowledge of the rumoured device - Comedy Insider (Feb 2014)
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post #4 of 28
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Originally Posted by Ireland View Post

"Citing unnamed sources with "limited but direct knowledge" of the rumored device."

That is one funny sentence.

 

It's like saying "Citing an Apple employee not in the (rumored) iWatch group but who has a friend who works in the (rumored) iWatch group..."

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post #5 of 28
So basically this device won't have any functionality that would require FDA approval/regulation.
post #6 of 28
I don't expect it to have glucose and hydration sensors at first either. That would probably raise the price a lot. In subsequent generations probably.
post #7 of 28
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Originally Posted by Rogifan View Post

So basically this device won't have any functionality that would require FDA approval/regulation.

It won't be a phone. Big 'duh' there.
Citing unnamed sources with limited but direct knowledge of the rumoured device - Comedy Insider (Feb 2014)
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Citing unnamed sources with limited but direct knowledge of the rumoured device - Comedy Insider (Feb 2014)
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post #8 of 28
Don't buy it. Apple has hired too many medical and health professionals to make another simple watch or fitness band. You don't need these types of employees for that, neither do you need a face-to-face with the FDA to release something that doesn't need their approval.
post #9 of 28
Quote:
Originally Posted by Ireland View Post

Quote:
Originally Posted by Rogifan View Post

So basically this device won't have any functionality that would require FDA approval/regulation.

It won't be a phone. Big 'duh' there.

They said FDA not FCC. Duh!
post #10 of 28
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Originally Posted by Phone-UI-Guy View Post

They said FDA not FCC. Duh!

Whoops! Lol. Won't be a phone anyway, though.
Citing unnamed sources with limited but direct knowledge of the rumoured device - Comedy Insider (Feb 2014)
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Citing unnamed sources with limited but direct knowledge of the rumoured device - Comedy Insider (Feb 2014)
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post #11 of 28
what? no automated external defibrillator function? fail!
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post #12 of 28
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Originally Posted by EricTheHalfBee View Post

Don't buy it. Apple has hired too many medical and health professionals to make another simple watch or fitness band. You don't need these types of employees for that, neither do you need a face-to-face with the FDA to release something that doesn't need their approval.
I guess the question is how long has Apple been working on this and how quickly could they get something approved by FDA? My guess is long term they are working on more advanced capabilities but we won't see them in gen 1.
post #13 of 28
Quote:
Originally Posted by Rogifan View Post

So basically this device won't have any functionality that would require FDA approval/regulation.

Michael Bromwich will need full access to this project to make sure it isn't violating the terms of Apple's punishment. /s

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post #14 of 28
Quote:
Originally Posted by EricTheHalfBee View Post

Don't buy it. Apple has hired too many medical and health professionals to make another simple watch or fitness band. You don't need these types of employees for that, neither do you need a face-to-face with the FDA to release something that doesn't need their approval.

 

I agree. I still believe there may be two types of iWatch up Apple's sleeve.

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post #15 of 28
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Originally Posted by Suddenly Newton View Post


Michael Bromwich will need full access to this project to make sure it isn't violating the terms of Apple's punishment. /s
 

Of course! What with all this talk of a "Health Book", I'm sure he'll be wanting to see the hardcover copy right away.


Edited by waybacmac - 2/11/14 at 2:34am

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post #16 of 28
Quote:
Originally Posted by EricTheHalfBee View Post

Don't buy it. Apple has hired too many medical and health professionals to make another simple watch or fitness band. You don't need these types of employees for that, neither do you need a face-to-face with the FDA to release something that doesn't need their approval.

 

Can you imagine a consumer-level product _AND_ an FDA-approved product? That would be a hell of a "new category" to enter! The margins would be fantastic. And the competition would be behind for years (due to the long FDA approval process). This would perfectly fit in with Cook's recent comments.

post #17 of 28
Yeah, somehow I don't buy that it's not going to have some rather boundary pushing health features.

First of all, they were concerned enough that it might be considered a medical device that they had a meeting with the FDA. It's just tracking steps like a fitbit, this would be entirely unnecessary.

Second, they hired Nancy Dougherty from Sano, a company that was working on this sensor:

"The needle-less, sensor-laden transdermal patch is painless (I handled a prototype, which felt like sandpaper on the skin) and will soon be able to monitor everything you might find on a basic metabolic panel%u2013a blood panel that measures glucose levels, kidney function, and electrolyte balance. Already, Sano%u2019s prototype can measure glucose and potassium levels. There are enough probes on the wireless, battery-powered chip to continuously test up to a hundred different samples, and 30% to 40% of today%u2019s blood diagnostics are compatible with the device."
post #18 of 28
Quote:
Originally Posted by Ireland View Post

It won't be a phone. Big 'duh' there.

That would be the FCC.

Oops : quipped by Phone UI Guy already
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post #19 of 28
So, at this point the iWatch appears to just be a display device, which frankly doesn't seem like it warrants Apple's time and effort. In short, all we learned is that while Apple is interested in health stuff, the iWatch's role will be secondary and won't require FDA approval, so it won't be a Fit alternative.

I wonder what's going to make the iWatch compelling? I'm more confused than ever.

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post #20 of 28
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Originally Posted by formosa View Post

Can you imagine a consumer-level product _AND_ an FDA-approved product? That would be a hell of a "new category" to enter! The margins would be fantastic. And the competition would be behind for years (due to the long FDA approval process). This would perfectly fit in with Cook's recent comments.



The 510k Premarket Approval process can typically be completed in less than 180 days and often less than 90 days.

Quote:
Originally Posted by Dave Marsh View Post

So, at this point the iWatch appears to just be a display device, which frankly doesn't seem like it warrants Apple's time and effort. In short, all we learned is that while Apple is interested in health stuff, the iWatch's role will be secondary and won't require FDA approval, so it won't be a Fit alternative.

I wonder what's going to make the iWatch compelling? I'm more confused than ever.


Please note that the unannounced device is, in fact, most likely a sensor-laden, self-monitoring device. The difference is that the device is not a medical device. The device will be an magnificent evolution of the quantified self. The device will almost certainly include blood glucose monitoring.

I believe that Apple is developing what is essentially a mobile sports performance laboratory. This is, if correct, a revolution in sports performance.
activity tracking
blood glucose
blood oxygen levels
thermoregulation
total energy expenditure

NOTE: The FDA heavily revised their guidance to distinguish between self monitoring blood glucose test systems (SMBGs) and blood glucose monitoring test systems for prescription Point-of- Care use just last month.
Edited by MacBook Pro - 2/10/14 at 6:55pm
post #21 of 28
Quote:
Originally Posted by AppleInsider View Post

Rumors about a future wrist-worn smart device from Apple continue to emerge, with one report Monday claiming the team in Cupertino, Calif., working on the so-called "iWatch" has grown to include more than 200 people.

If it also does golf course GPS on it's own, not relying on my iPhone, I'm in.

If not my next watch will be a Garmin golf course GPS watch this spring.

 The iWatch will then have to wait for a few years!

post #22 of 28
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Originally Posted by Pooch View Post

what? no automated external defibrillator function? fail!

That's not a shock.
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post #23 of 28
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Originally Posted by digitalclips View Post


That's not a shock.


Budum tss

 

I wonder how big this thing will actually be considering all the stuff they're supposedly packing into it

post #24 of 28

Direct drug injection feature.

post #25 of 28
Quote:
Originally Posted by junkdrop1 View Post

Direct drug injection feature.

Ah, yes...a "sports enhancement" device. Apple will call it the iCan in a nod to one of it's investors.
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post #26 of 28
Can't wait. AAPL stock will look cheap at these prices once the world realises the company can still popularise and dominate new product categories. Note they don't have to be able to invent the category, just to take it and make it work at Apple levels of user experience and provide that quality at truly vast production scaling.
post #27 of 28
I'd like an accessory that disables the iPhone or iPad if away from one's person. I know others make them, but an Appley one would be better.
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post #28 of 28
In 2011 Apple had 60,000 employees. It is much higher that that now. So 200 hardly significant.
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