Apple’s iWatch awaits FDA approval; device to include blood glucose, sweat analysis sensors

“The iWatch has become one of the most anticipated gadgets of the year, and for many months it’s been the source of tons of speculations and rumors,” G 4 Games reports. “This is to be expected given Apple’s huge influence on the market, especially since the iWatch would be the company’s fist ‘wearable.'”

“According to the latest reports coming from the Chinese media (citing ‘Apple insiders’), iWatch’s development has already been completed (meaning design, technical specs, features, etc),” G 4 Games reports. “However, the gadget is being held back (aka is not being manufactured yet) because it needs to be certified by the U.S. Food and Drug Administration (FDA).”

“Much like the previous rumors have suggested, this new reports suggests that the iWatch will include a wide range of biometric sensors on-board, including heart rate, blood pressure and blood glucose sensors,” G 4 Games reports. “More so, based on these latest reports Apple has also developed an in-house sweat analysis sensor for the iWatch. As such, Apple is apparently working on certifying the smartwatch as a medical equipment.”

Read more in the full article here.

MacDailyNews Take: Sweat analysis. You know Ballmer’s secretly excited now.

[Thanks to MacDailyNews Readers “Fred Mertz” and “Dan K.” for the heads up.]

Related articles:
Apple to begin mass production of 2.5-inch iWatch with wireless charging and pulse sensor in July, sources say – June 19, 2014
LG to supply Apple iWatch display in two sizes for late 2014 release, sources say – April 15, 2014
Apple’s iWatch said to come in two sizes, high-end model to cost several thousand dollars – April 10, 2014
Apple iWatch to sport 1.52-inch curved OLED, set for summer launch, report claims – January 20, 2014
Apple to make two iWatch models: 1.7-inch display for men, 1.3-inch for women, sources say – November 13, 2013

44 Comments

  1. The FDA is only interested in filling their own pockets. They have no interest in the publics safety . If that were true they would be taking Monsanto to court.

      1. Tell me how the FDA is lining their pockets! If anything they have way too much interest in public safety.

        Sound reasoning, my ass!
        Monsanto is a whole other kettle of fish, and the last time I checked taking things to courts was a different agency.

        As a diabetic, the idea of monitoring blood sugar this way sounds pretty cool!

    1. Have you ever built a medical device and submitted it to the FDA? You clearly have no real knowledge. How do you think the FDA fills their pockets? They are a government agency and their salaries don’t change based on device approvals. Their focus is patient safety as it relates to medical equipment and drugs. Their process is cumbersome and sometimes too slow, but their purpose and goals are worthwhile. I have built, submitted, had approved, and sold medical devices. What have you done?

      The long-term problems with Monsanto have more to do with long term robustness of our food supply due to decreased genetic diversity of the crop species. Their strong arm tactics relating to non-Monsanto farmers, (backed by our courts and legislature), are the biggest short term evil and that is not the purview of the FDA.

    2. Yes, this explains why it appears Apple has been so slow to innovate (ahem), dealing with a federal bureaucracy designed to slow innovation. Besides, they probably lost Apple’s email application …

      1. Hey, their hard drive failed, without backup, and then they recycled it and then their dog ate it.

        Nixon was a saint compared to the idiotic fux in D.C. today.

        1. The ONLY difference is Waterhate was relentlessly pursued non-stop by the dogged investigate journalists of another era at the WPOST and NYT.

          Today, when one of their OWN runs The Wash House … crickets.

  2. If the device has noninvasive blood glucose testing I would pay up to $1000 to buy for my diabetic wife… That would be a leap forward that could hardly be quantified by money… The phrase the next big thing wouldn’t even cover that.

        1. Gluco-watch was discontinued years ago:

          “Animas Corporation, which is now a Johnson & Johnson company, purchased the intellectual property and all of the assets of the original manufacturer of the GlucoWatch G2 Biographer, Cygnus Inc. in Redwood City, California.
          Animas Corporation is no longer selling the current model GlucoWatch G2 Biographer system. Animas continues to sell AutoSensors and provides customer support for the GlucoWatch system through July 31, 2008.”

      1. NO. It’s not going to ever be possible to measure blood glucose level without actually accessing BLOOD. The surface of skin is dead cells. Have fun measuring anything to do with blood through a layer of dead cells without puncturing through them to reach… BLOOD.

        Keep in mind, this article is based on “latest reports coming from the Chinese media”. IOW: Expect a SCAM.

        1. Apparently, it has already been done and approved by the FDA.
          The GlucoWatch required a prescription, sold for $700 and cost $5000/year to use.
          It is no longer sold but the IP was bought by Johnson & Johnson.

          1. And, it would have to be invasive to work. I can easily see how the puncturing gear can be added to a watch and how the blood would then be analyzed on the spot. That’s not a problem. But to expect a superficial skin measurement of blood glucose is fantasyland. Not gonna happen.

            And please trollish folk, don’t misconstrue my words here. Just read what I wrote and don’t read into it. I wrote exactly what I meant to write. Just making sure you understand.

            1. You don’t seem to have read what I wrote or followed the link.
              I’ll type slowly so you can read it this time.
              It’s been done.

            2. Fair enough George. And yet, from the article you linked:

              that will test your blood glucose through fluid drawn from under your skin with electrodes, rather than your blood itself.

              Which means what? It means the device, when it existed, was still having to go below the first layer of skin, the dead stuff, down into your tissue. I note that it didn’t have to go into a blood vessel for actual blood! But getting beneath the surface of the skin was still required, thankfully not so deep. I like it! It sounds like it was an improvement. Hopefully the readings were useful. I note that it had a calibration step with each new electrode pad.

            3. There is currently NO VIABLE way to test blood sugar or glucose levels without being inside the body.

              Even the current gold standard for continuous glucose monitoring, “Dexcom,” has a small needle/sensor that goes under the skin for a week at a time and measures the glucose between the cells in Interstitial fluid.

              This still requires at least 2 finger stick blood tests per day as calibration.

              Ill repeat, there is 0% chance that Apple has been able to create an entirely new technology (reliable, cheap, accurate, non-disposable) glucose testing product without going through extensive clinical trails.

      2. I am a type-1 diabetic. I currently use an insulin pump and a continuous glucose monitor called a Dexcom.

        I HOPE Apple has pulled off a miracle here.

        Understand that non-invasive glucose sensing watches have existed before and were complete and total failures. Further, today’s gold standard for Continuous Glucose Monitoring is the Dexcom and that still requires a finger stick at least every 12 hours.

        How would/could Apple have created a new glucose sensing technology without doing any clinical trials? If there were clinical trails for an iWatch going on for the last few years we would all know about it. You can’t keep that secret.

    1. As a medical device, it would be eligible for Mediacare, Mediaid, Obamacare, VA and TRiCare as well as private insurers to pay for at least partially. Greatly expands the market potential! Huge potential.

  3. I think the bitching about the FDA would be way louder if lax approval procedures resulted in an injury to your loved ones. Personally, considering the risks involved with all things medical, some prudence in approving things is more ‘prudent’!

    1. Probably want to leave it home in a first date situation, maybe even all the way to third base. Don’t want any alarms sounding at inopportune moments.

  4. It’s just ridiculous to think that Apple would sell a device that required invasive sensing. They are not equipped to function as a medical device company.

    1. Why not? Look at all the out of work CEOs that said Apple couldn’t build a successful cell phone. It’s simply technology. Mechanical, electronic and software design. Seems there are few better at this than Apple right now.

      1. It is not simply mechanical, electronic, and software technology, but also biotechnology. People die from malfunctioning medical devices and from the invasive procedures that support them. There is a quantum leap in liability risk to the sellers and health personnel who use the devices, which is why the FDA regulates them carefully. The service demands for these devices alone explains why the medical device industry is highly specialized.

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