What the Apple Watch Series 4’s FDA clearance actually means

“Apple announced that the US Food and Drug Administration cleared two new features for the Apple Watch Series 4. One is an advanced method of monitoring the heart called an electrocardiogram (EKG), and the other is the Watch’s ability to detect and notify the user of an irregular heart rhythm,” Angela Chen reports for The Verge. “Both features will be available on the device later in 2018 (not at launch).”

“The FDA clearance letters for both the EKG and irregular rhythm notification functions note that they are not intended to be used by people under the age of 22,” Chen reports. “Second, it’s important to understand that the FDA has ‘cleared’ both apps, but that’s not the same as ‘approving’ them.”

“The most advanced is FDA approval, which is done only for Class III products, or technologies that might have higher risk but also a higher benefit. (Think: implantable pacemakers.) Approval is the gold standard, and companies need to do a lot of testing to receive this designation,” Chen reports. “The Apple Watch is in Class II. For Class II and Class I, the FDA doesn’t give ‘approval,’ it just gives clearance. Class I and Class II products are lower-risk products — as Speer puts it, a classic Class I example is something like a tongue depressor — and it’s much easier to get clearance than approval.”

“Apple, however, has emphasized that it has received a ‘de novo’ classification for the EKG feature,” Chen reports. “That means that… It’s unlike anything else on the market. It is the first direct-to-consumer EKG wearable. (Last year, the FDA approved the AliveCor KardiaBand, a watch accessory that essentially does the same thing, but that wasn’t direct-to-consumer.)”

Read more in the full article here.

MacDailyNews Take: AliveCor? DeadCor is more like it.

AliveCor CEO Gundotra says that Apple is using ‘alternative facts’ to market Apple Watch Series 4 – September 13, 2018
Apple Watch Series 4 redesigned with a stunning new display, breakthrough electrocardiogram, and much more – September 12, 2018


  1. AliveCor offers the options of having your ECG read by either a general doctor or a cardiologist either within a few hours or overnight as well as an immediate classification. So far, Apple isn’t offering anything nearly that comprehensive and flexible.

    1. “Apple isn’t offering anything nearly that comprehensive and flexible.“

      Maybe not, but you probably buy an Apple Watch for the price of two or three AliveCor tests.

      1. $19 for a full evaluation by a certified cardiologist within 24 hours or $9 for an assessment by a cardiac technician within 1 hour. If I were in a situation where I felt (literally) that I needed more details than that, I would have already called 911. AliveCor emails me a monthly report of all of my recorded EKGs which I take to my bi-montly cardiac appointments. Apple Watch 4 is compatible with AliveCor’s Kardia Band. For now, AliveCor is certainly an option worth investigating if you are concerned about cardiac issues.

  2. This is one issue that is going to need to time to mature.

    FIrst, someone who sees an odd and rushes to the ER will find that the bills related to an ER visit are pretty high. That can calm down a hypochondriac rather fast, resulting in a more stable use of the EKG.

    Something else is going to develop and that is the back end of the EKG, where companies (maybe including Apple) develop evaluation services for a small fee – probably $25 or so. You send in a “strip” from the Watch or iPhone and get a text in return, or a call if there is a significant issue. There is already a lot of software available from the Stanford Study so this isn’t a huge jump.

    Readings by local hospitals/VA facilities are also possible in the future.

    Overall this is a huge potential and I believe that a lot of “providers” will be thinking about how to develop their programs.

    1. “Something else is going to develop and that is the back end of the EKG, where companies (maybe including Apple) develop evaluation services for a small fee – probably $25 or so.”

      You mean like I’ve been doing with AliveCor for a little over a year now? Cheaper than $25 though. Readings are also sent to my actual cardiologist who reviews them as well.

      I’m likely going to upgrade to the new watch. I don’t understand why MDN has such a hard-on about dissing AliveCor. What the CEO was true. They’ve been selling their device directly to consumers for over a year now. Sorry, but Apple wasn’t the first.

      1. I believe the difference is that their divice is not stand alone and requires a smartphone or watch to work.

        Where as Apples solution is a self sufficient, standalone device.

        Please correct me if im wrong . ……

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