Apple (AAPL) iWatch release delayed by FDA medical device certification

If a new rumor is to be believed, then the long delay of the Apple (NASDAQ:AAPL) iWatch is due to the Cupertino electronics company seeking FDA certification of the wearable as a medical device. As reported by G4Games, which traces the rumor back to Chinese reporters who cite anonymous “Apple insiders,” the iWatch’s exact release is still uncertain due to Apple (AAPL) waiting on the United States Food and Drug Administration, whose lengthy testing is frequently complained about but has prevented such problems as thalidomide use in the U.S.

If the iWatch has indeed been submitted for FDA approval, this fact would likewise explain why Apple is even more silent than usual about its new form factor. Until the certification is actually granted, the iWatch’s future is somewhat in doubt, even if the odds favor its successful transition from lab to consumer sales. Apple (AAPL), based around a canny, worldly-wise corporate culture, would not risk an announcement that could later be proven totally false.

Human HeartAccording to an article on Medscape, FDA certification of a medical device requires anywhere from three to seven years for completion. Devices that are similar to existing ones are certified faster and with less hassle, since the existing devices have already demonstrated that the design is safe and effective. If Apple has petitioned on the basis of the iWatch being similar to existing sports and health monitoring watches, then the iWatch may be classified as a Class I device, “Low Risk.” This translates to an approval time probably closer to three years than seven.

The smartwatch seems likely to be linked directly to the Mayo Clinic and other top American medical facilities, as coding in iOS 8 indicates. The iWatch will probably include at least four biometric sensors, measuring heart rate, blood glucose, blood pressure, and perspiration chemistry. The “sweat analysis” function seems to be proprietary to Apple (AAPL), and would be used during exercise to warn of impending dehydration (or, in rare cases, excessive water use).

The latest rumor also seems to solve the “mystery” of why Apple spent the first few months of the year hiring experts in medicine. Hiring such people is a prudent move if FDA certification is indeed being sought, since the medical aspects of the iWatch would need to be designed to the highest current medical standards to quickly pass the certification process and reach store shelves on schedule.

  • mds

    Another bullshit article. There has never been a watch announced by AAPL. It was always press rumor and manipulating. Now they are making excuses for something that possibly never was.
    Only reason for approval is prescription-like reimbursement as a necessary medical device. So what. If it’s real it can still be announced as imminent but delayed.

  • slopemope

    Do we think they are long put spreads? Me think so. Very suspicious after a big run-up.

  • ScoobyDoo101

    GNC and CVS only SELL medical devices they do not MANUFACTURE medical devices as Apple is proposing to do, so there is a difference.

  • Billboy

    3 years approval time for a Class 1 device!!! You have no idea about what you are writing , do you. Please do your research before you post half truths and lies.

  • mds

    AAPL does not need FDA approval any more than GNC needs it; or CVS for heart monitors etc. that they have been selling for years. In this case it is the equivalent to the Good Housekeeping seal of approval. Meaningful to some and ignored by most.
    All FDA approval will possibly do is make it payable by a health insurer.
    The FDA blocks advantages in this country that benefit many around the world. They are about as lame as the IRS and the Fed.
    Business knows how to do business; not politicians or talking heads.