Is the FDA making us wait for iWatch?

(Photo: Fuse Chicken)

(Photo: Fuse Chicken)

While some reports are claiming that Apple is still finalizing the specifications for its first generation iWatch ahead of the supposed October launch, another set of reports — supposedly backed up by insider sources — put forward another theory.

And it makes a lot of sense.

According to Chinese website Laoyaoba, Apple is awaiting certification from the U.S. Food and Drug Administration (FDA) to get the iWatch approved as medical equipment, before it enters mass production for a fall launch. It was reported back in January that Apple had met with the FDA to discuss a number of topics, and a Freedom of Information Act request recently revealed that Apple sees the push toward mobile health tracking as a “moral obligation” in keeping with Tim Cook’s desire for Apple to be a “force for good” in the world.

Since devices designed to track health and fitness — in addition to applications of the HealthKit API announced at WWDC (Mayo Clinic, Stanford Hospital & Clinics, Penn Medicine, Johns Hopkins Medicine, and the Cleveland Clinic have all been disclosed as partners) — will have an important bearing on the wellbeing of users, it’s no surprise that Apple would have to jump through some hoops prior to releasing its next big product.

It’s already been reported that the iWatch will be far ahead of other existing smartwatches thanks to its smart sensors, and Laoyaoba’s report adds even more detail to this: claiming that the iWatch will have the ability to measure/analyze heart rate, blood pressure, blood glucose, and sweat.

While a lengthy approval period is likely involved with bringing all of these to a mass-market device like the iWatch, most people expect that the iWatch will be revealed and launched in October this year.

  • Grunt_at_the_Point

    “Making us wait” – sounds like abuse of power. Yet the article provides no evidence of that occurring. Actually, I think Apple put the horse before the cart when they initiated the iWatch project. Apple has only recently hired experts in the area of medical technologies to oversee the iWatch development. No, I think the iWatch was proceeding well until someone at Apple realized what they are trying to do needs FDA approval.

    The FDA works on its schedule not Apple.

    • San Diego Dave

      “The FDA works on its schedule not Apple.”

      Hence, the FDA could be making us wait longer relative to what Apple wants. Way to be all super critical of the article and then just agree with its main point.

      • Grunt_at_the_Point

        No, my caption would have read, “iWatch awaiting FDA Approval”. The article caption implies the FDA is impeding the iWatch release.

      • lucascott

        I believe the bigger point is that it would be Apple that is wanting this certified as a legit medical device rather than putting it out there as a fitness device that doesn’t require the same testing (which would explain the prior meetings).

        NOT that the FDA called up Apple and is forcing tests on the device and taking their sweet time doing them, as the hit whoring headline suggests

        And I rather like the idea. I would love to see a system where not only are my medical records online for a doctor or hospital to access as needed (even if I move homes or even doctors) but there can be constant updates of vital information which can, with my consent, be sent to said doctors as would be needed. So say I’m a diabetic and I need to monitor my weight, food intake, exercise and blood glucose levels. And this ‘iWatch’ can help me track my movement and glucose levels and report them to the system. I have given permission for reports to be sent to my doctor. And via those he sees a potentially bad trend in my levels. I can be alerted to make a lifestyle adjustment or even come in for a check up possibly before it is a major issue.

        Perhaps this ‘iWatch’ might also have a method, such as a code number, to ID me in the system in the event that I can’t speak and my iPhone is not working for a paramedic to see that i’m diabetic, or whatever. Or even just ID my major issues. Like a digital medalert badge.

  • Patrick Phillips

    EVERYTHING the FDA does is either impeding progress or fast tracking danger and death. It is a political organization, yes, political, that holds a monopoly of power to decide life or death issues and they have ruined inordinately more lives than they’ve helped, both by impeding beneficial drugs from coming to market in a timely manner, and by approving drugs and products that’ve killed or maimed hundreds of thousands (remember Vioxx).

    I’ve been an RN my entire career and grown up in a household of physicians and other nurses. The FDA is a menace and serves no purpose other than to service politically connected corporations and hamstring their competition, which has ALWAYS been it’s purpose. Look up the term “Moral Hazard” and you sum up exactly what the FDA and other “regulatory” bodies are. Or better yet, read Gabriel Kolko.

About the author

Luke DormehlLuke Dormehl is a UK-based journalist and author, with a background working in documentary film for Channel 4 and the BBC. He is the author of The Formula: How Algorithms Solve All Our Problems, And Create More and The Apple Revolution, both published by Penguin/Random House. His tech writing has also appeared in Wired, Fast Company, Techmeme, and other publications. He'd like you a lot if you followed him on Twitter.

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