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

Posted:
in Future Apple Hardware edited February 2014
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.
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Comments

  • Reply 1 of 29
    sockrolidsockrolid Posts: 2,788member

    Looking forward to seeing the Apple Wrist-Top.

    Probably won't buy one though.

  • Reply 2 of 29
    irelandireland Posts: 17,617member
    [QUOTE]Citing unnamed sources with "limited but direct knowledge" of the rumored device.[/QUOTE]

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

    Comedy insider.

    Time to adjust me signature.
  • Reply 3 of 29
    irelandireland Posts: 17,617member
    dupe

    (delete Kas)
  • Reply 4 of 29
    sockrolidsockrolid Posts: 2,788member
    Quote:

    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..."

  • Reply 5 of 29
    rogifanrogifan Posts: 10,669member
    So basically this device won't have any functionality that would require FDA approval/regulation.
  • Reply 6 of 29
    clemynxclemynx Posts: 1,510member
    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.
  • Reply 7 of 29
    irelandireland Posts: 17,617member
    rogifan wrote: »
    So basically this device won't have any functionality that would require FDA approval/regulation.

    It won't be a phone. Big 'duh' there.
  • Reply 8 of 29
    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.
  • Reply 9 of 29
    ireland wrote: »
    rogifan wrote: »
    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!
  • Reply 10 of 29
    irelandireland Posts: 17,617member
    They said FDA not FCC. Duh!

    Whoops! Lol. Won't be a phone anyway, though.
  • Reply 11 of 29
    poochpooch Posts: 768member
    what? no automated external defibrillator function? fail!
  • Reply 12 of 29
    rogifanrogifan Posts: 10,669member
    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.
  • Reply 13 of 29
    rogifan wrote: »
    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
  • Reply 14 of 29
    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.

  • Reply 15 of 29
    Quote:

    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.

  • Reply 16 of 29
    This writer and rumor generator needs a Google device to check his/ her brain.
  • Reply 17 of 29
    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.

  • Reply 18 of 29
    jakebjakeb Posts: 557member
    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."
  • Reply 19 of 29
    dasanman69dasanman69 Posts: 12,980member
    ireland wrote: »
    It won't be a phone. Big 'duh' there.

    That would be the FCC.

    Oops : quipped by Phone UI Guy already
  • Reply 20 of 29
    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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