Apple Watch Series 4 is first consumer device to receive FDA clearance for ECG monitoring ...

Posted:
in Apple Watch edited September 12
The Apple Watch Series 4 has received clearance from the U.S. Food and Drug Administration to operate as an over-the-counter ECG-monitoring device, becoming the first device available to consumers over the counter to offer the functionality.




Confirmed on-stage at Apple's September event, the approval from the FDA for the Apple Watch's electrocardiogram functionality makes it one of the only devices on the market to provide its users EKG readings. Typically ECG devices are not available for purchase by consumers, making the Apple Watch Series 4 an exception.

Similar technology is already in use by AliveCor, which markets the KardiaBand accessory for Apple Watch. The company reached out to AppleInsider to note that KardiaBand was first to receive over-the-counter FDA clearance in 2014, three years prior to wide general release in November 2017. As CNBC reporter Christina Farr explained in a tweet, however, users must have their first ECG reviewed by a doctor in order to "unlock," or view, the reading.

AliveCor details the process on its website, saying that "due to regulatory necessity, new U.S. accounts are required to have their first EKG reviewed by a U.S. board-certified cardiologist free of charge (a $19 value within the app)."

The Apple Watch, on the other hand, has FDA clearance to show its first ECG to users without a doctor review.

Apple has been pushing its Apple Watch to become a more useful device for healthcare, and has worked with the FDA about its ambitions. The company has previously talked to the head of the FDA about "mobile medical applications" in 2014, while in 2017 it was picked to join eight other companies in an FDA pilot program to avoid problematic regulations that could slow down the development of new health-related products.

The new Apple Watch now has electrodes in the sapphire crystal and digital crown, allowing users to take an ECG at any time using the included app. All ECG recordings are stored in the Health app, and can be shared with healthcare professionals at a later time.

The ECG functionality will be available at first to customers in the United States, with Apple also working to bring the feature to other markets at a later time.

Updated with clarification regarding AliveCor's KardiaBand.

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Comments

  • Reply 1 of 69
    Now bring on the non-invasive glucose monitoring bands!
    Soliclaire1jbdragonwatto_cobra
  • Reply 2 of 69
    mac_128mac_128 Posts: 3,172member
    Looks like all those DC dinners and meetings paid off ;-)
    edited September 12 watto_cobra
  • Reply 3 of 69
    will be available at first to customers in the United States

    The price in the other counties should be lower because of less features.
  • Reply 4 of 69
    viames said:
    will be available at first to customers in the United States

    The price in the other counties should be lower because of less features.
    No, that doesn't really make sense at all. 
    Solidavenanomejbdragonlolliver
  • Reply 5 of 69
    Some features of iOS can be tricked into working outside the US simply by setting your region in the Settings/General/Regions to the US. Will the ECG work outside the US if we set our region to USA?
    watto_cobra
  • Reply 6 of 69
    SoliSoli Posts: 8,288member
    mac_128 said:
    Looks like all those DC dinners and meetings paid off ;-)
    Are you suggesting Apple bribed their way to FDA approval?
    GeorgeBMacjbdragon
  • Reply 7 of 69
    SoliSoli Posts: 8,288member
    This is a big deal. I wonder if you could wear a BT connected device on your finger so that could take an EKG at timed intervals, like every 15 minutes while you sleep. Such a device could also be checking your oxygen saturation and sending the results to your Watch, too. I know this could work with oxygen, but I'm not sure if the EKG needs to have a direct connection at all times, or if can send data via BT to be processed by the Watch.

    viames said:
    will be available at first to customers in the United States
    The price in the other counties should be lower because of less features.
    If the utility isn't good enough for the price then don't buy it. Consumerism is that fucking simple.
    edited September 12 radarthekatanomelolliverAnilu_777watto_cobra
  • Reply 8 of 69
    dunksdunks Posts: 1,220member
    The ECG functionality will be available at first to customers in the United States, with Apple also working to bring the feature to other markets at a later time.
    I really hope this doesn't take over a year like it did with Apple Pay.
    svanstromwatto_cobra
  • Reply 9 of 69
    Soli said:
    viames said:
    will be available at first to customers in the United States
    The price in the other counties should be lower because of less features.
    If the utility isn't good enough for the price then don't buy it. Consumerism is that fucking simple.
    Right! Buy the newly lower priced Series 3 and be happy at all the money saved!
    edited September 12 watto_cobra
  • Reply 10 of 69
    SoliSoli Posts: 8,288member
    dunks said:
    The ECG functionality will be available at first to customers in the United States, with Apple also working to bring the feature to other markets at a later time.
    I really hope this doesn't take over a year like it did with Apple Pay.
    With Apple Pay they have to get banks involved and they have to spend money to update their systems to support Apple Pay. With this I'd guess it's probably easier because they just need approval from various counties. This might be the opposite of the Apple Pay rollout where the countries that are/were slowest to adopt Apple Pay are the quickest to allow EKG on the Watch because their FDA equivalent has lower scrutiny, yet supporting Apple Pay requires about the same amount of effort for every financial institution around the world.
    lolliverwatto_cobra
  • Reply 11 of 69
    radarthekatradarthekat Posts: 2,570moderator
    An FDA-approved medical grade device that allows easy collection and delivery of historical ECG data to a doctor.  Hmm.  Sounds like a device that might be covered by insurance, and might be subsidized by employers.  
    hubbaxjbdragonwatto_cobra
  • Reply 12 of 69
    Maybe when ECG comes to my country I will jump from my 3rd Gen cellular. Not really missing anything here right now. For sure, if I would not have one already th Gen 4 would be it. Oh, and when ECG arrives, I am sure I need to pass by the local store, you know, just out of curiosity to check on the new dimensions... ;-)
    Oh, and it would be really cool to round that visit off with Gen 2 AirPods, the not yet completely classsified as vaporware charging mat, so the the Watch would not feel so alone in the bag. Did I juste day Watch? 
    Anilu_777watto_cobra
  • Reply 13 of 69
    The pricing is disappointing.  $100 more for a stainless steel.  The 42 was $649, now $749.  I will wait a bit because that's getting pricey.  Also the stainless steel is not being sold on Series 3 anymore.  
  • Reply 14 of 69
    melgrossmelgross Posts: 31,053member
    dunks said:
    The ECG functionality will be available at first to customers in the United States, with Apple also working to bring the feature to other markets at a later time.
    I really hope this doesn't take over a year like it did with Apple Pay.
    Blame the other countries. It’s their regulators that decide. If it were Apple, they’d do it now.
    claire1jbdragonwatto_cobra
  • Reply 15 of 69
    melgrossmelgross Posts: 31,053member

    An FDA-approved medical grade device that allows easy collection and delivery of historical ECG data to a doctor.  Hmm.  Sounds like a device that might be covered by insurance, and might be subsidized by employers.  
    Apple watches and some FitBit devices are already subsidized by some insurance companies, and given to their employees. This will just make it closer to ubiquity.
    edited September 12 watto_cobra
  • Reply 16 of 69
    sflocalsflocal Posts: 4,244member
    This is huge.  Getting FDA approval for what is essentially a new device/market is huge.  Apple certainly is a lone player in this field.  This opens the door for the Apple Watch to enter new areas of medical uses.  I'm really excited for this!  If they can figure out non-invasive Glucose monitoring, it will be absolutely huge.

    I think I see a bead of sweat going down Samsung's face.  Good luck trying to knockoff an FDA device!
    jbdragonlollivermacplusplusAnilu_777watto_cobra
  • Reply 17 of 69
    melgross said:
    dunks said:
    The ECG functionality will be available at first to customers in the United States, with Apple also working to bring the feature to other markets at a later time.
    I really hope this doesn't take over a year like it did with Apple Pay.
    Blame the other countries. It’s their regulators that decide. If it were Apple, they’d do it now.
    In the past you’d say “king for a day”. Now that might easily apply to regulation authorities (and maybe the other part of the FNM album title, too) ;-)

    On a more serious side: I would call it close to priceless to have the health features the AW4 offers, when I am a bit older and would not know through regular checkups about my heart condition as well as I do,
    edited September 12 jbdragonwatto_cobra
  • Reply 18 of 69
    claire1claire1 Posts: 462unconfirmed, member
    bostonbri said:
    The pricing is disappointing.  $100 more for a stainless steel.  The 42 was $649, now $749.  I will wait a bit because that's getting pricey.  Also the stainless steel is not being sold on Series 3 anymore.  
    So you're gonna wait for next gen then the next gen then the next gen?
    lolliverwatto_cobra
  • Reply 19 of 69
    SoliSoli Posts: 8,288member
    Was the GSP+Cellular option only $70 more than the GPS option last year?
  • Reply 20 of 69
    claire1claire1 Posts: 462unconfirmed, member

    sflocal said:
    This is huge.  Getting FDA approval for what is essentially a new device/market is huge.  Apple certainly is a lone player in this field.  This opens the door for the Apple Watch to enter new areas of medical uses.  I'm really excited for this!  If they can figure out non-invasive Glucose monitoring, it will be absolutely huge.

    I think I see a bead of sweat going down Samsung's face.  Good luck trying to knockoff an FDA device!
    Samsung isn't even a player anymore. I can see the Fitbit knockoffs sweating though. 
    jbdragonlolliverwatto_cobra
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