Apple Watch Series 4 EKG tech got FDA clearance less than 24 hours before reveal

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in Apple Watch
The electrocardiogram feature in the Apple Watch Series 4 got clearance from the U.S. Food and Drug Administration just a day prior to Apple's Sept. 12 press event, reportedly causing some stress at the company.

Apple Watch Series 4


The FDA's classification letters to Apple were dated Sept. 11, Fast Company noted on Tuesday. The site added that just after the Sept. 12 press event, it overheard an Apple worker talking about the close timing "in exasperated tones" outside the Steve Jobs Theater.

Had the clearance not been granted, Apple might have had to radically revise COO Jeff Williams' presentation on Sept. 12, in which the EKG technology and its FDA clearance were front and center. Williams claimed that the Series 4 is the "the first EKG product offered over the counter directly to consumers."

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.

The FDA has technically only cleared an "Irregular Rhythm Notifcation Feature" and EKG software that can detect signs of arrythmias. The FDA wrote that the Watch's EKG feature "is not intended to provide a diagnosis," and "not intended for use by people under 22 years old."

Indeed the Series 4 won't even ship with the EKG app installed when it launches on Sept 21. That's coming in an over-the-air update before the end of 2018.

Apple was likely eager to tout the feature in advance however as a way of differentiating its product not just from rivals like Garmin and Fitbit, but earlier Watch models, since the biggest upgrade is otherwise a slightly larger screen.



Comments

  • Reply 1 of 19
    lkrupplkrupp Posts: 7,306member
    As coincidence would have it I had an appointment with my cardiologist yesterday. I breached the subject of the Apple Watch and he was well aware of it. He told me the medical community is very interested in this development but that they want much more information on how it works, how accurate it is, etc. He also explained his take on the difference between FDA “clearance” and FDA “approval.” The operative word is treatment. If a device is going to be used to actually perform medical treatment, like say the insulin pumps some diabetics wear, that requires FDA approval. The portable EKG machine in his office does not perform medical treatment but is a diagnostic tool he uses and would only require FDA clearance that it works as designed.

    Meanwhile I have read a couple of articles from critics who worry that this technology will cause too many false positives, cause more people to go to the emergency room which could affect the availability of prompt medical care for those who really do have a problem. That kinda makes sense I guess.

    Then he proceeded to lecture me once more on losing weight and exercising more often. I’m trying, Doc, I’m trying, but that cheesecake is beckoning me.
    edited September 2018 JWSCkidrock2199randominternetpersonneo-techSolidavenboltsfan17lostkiwicecil444eightzero
  • Reply 2 of 19
    The electrocardiogram feature in the Apple Watch Series 4 got clearance from the U.S. Food and Drug Administration just a day prior to Apple's Sept. 12 press event, reportedly causing some stress at the company.

    If only there was a way to be sure their hearts were healthy enough to handle that stress.

    Solilostkiwicornchiplolliverappleheadclaire1watto_cobra
  • Reply 3 of 19
    eightzero said:
    The electrocardiogram feature in the Apple Watch Series 4 got clearance from the U.S. Food and Drug Administration just a day prior to Apple's Sept. 12 press event, reportedly causing some stress at the company.

    If only there was a way to be sure their hearts were healthy enough to handle that stress.

    When I ask my doctor if my heart is healthy enough for sex, she says, "Well, let's just try a few tests ..." And after the tests she says, "Yours is. Mine isn't."
    edited September 2018 lostkiwieightzerocornchipappleheadjony0claire1watto_cobra
  • Reply 4 of 19

    lkrupp said:
    Meanwhile I have read a couple of articles from critics who worry that this technology will cause too many false positives, cause more people to go to the emergency room which could affect the availability of prompt medical care for those who really do have a problem. That kinda makes sense I guess.
    It might prevent some visits as well. If you're freaking out or having panic attack but your Watch says everything is just fine, it might save a trip to ER.
    space2001Solimwhitelostkiwilollivertoysandmejony0watto_cobra
  • Reply 5 of 19
    mike1mike1 Posts: 1,923member
    I'm pretty sure Apple prepared some Plan B slides that said "FDA clearance expected soon" or the like.
    randominternetpersonD_CMillsmac_doglollivertoysandmeappleheadjony0claire1watto_cobra
  • Reply 6 of 19
    eightzero said:
    The electrocardiogram feature in the Apple Watch Series 4 got clearance from the U.S. Food and Drug Administration just a day prior to Apple's Sept. 12 press event, reportedly causing some stress at the company.

    If only there was a way to be sure their hearts were healthy enough to handle that stress.

    When I ask my doctor if my heart is healthy enough for sex, she says, "Well, let's just try a few tests ..." And after the tests she says, "Yours is. Mine isn't."
    That's like the one where:  The guy tells his boss that he's found a new position, and she responds: Good, Let's try it!
    king editor the gratelostkiwiclaire1watto_cobra
  • Reply 7 of 19
    Isn't EKG different from ECG?
  • Reply 8 of 19
    Just googled them - they're identical.
    claire1
  • Reply 9 of 19
    TrueNorth said:
    Isn't EKG different from ECG?
    According to Google, the answer is no.  The K is the from German version of cardiac.
    cecil444GeorgeBMacjony0
  • Reply 10 of 19
    SoliSoli Posts: 9,261member
    TrueNorth said:
    Isn't EKG different from ECG?
    Nah. Same thing with two different acronyms.

    What’s the Difference Between ECG and EKG?

    The fact of the matter is that an ECG and an EKG are the exact same thing. That’s right, the most surprising difference between an ECG and an EKG is that there is no difference at all.  Both ECG and EKG stand for electrocardiogram.

    So, if an ECG is the same thing as an EKG, then why are there two different abbreviations? It’s actually quite simple—when the word electrocardiogram is translated into the German language, it is spelled Elektro-kardiographie. EKG is just the way some people choose to say ECG based on this translation.

    I didn't even know about the German spelling but I've mostly seen EKG going back to my youth so I tend to use both acronyms interchangeably.
    king editor the gratetechprod1gylostkiwi
  • Reply 11 of 19
    TrueNorth said:
    Isn't EKG different from ECG?
    According to Google, the answer is no.  The K is the from German version of cardiac.
    There’s also an echocardiogram, which is a different thing and which some people erroneously label as ECG, but that’s incorrect; ECG and EKG both refer to electrocardiograph and are interchangeable.
  • Reply 12 of 19
    SoliSoli Posts: 9,261member
    cecil444 said:
    TrueNorth said:
    Isn't EKG different from ECG?
    According to Google, the answer is no.  The K is the from German version of cardiac.
    There’s also an echocardiogram, which is a different thing and which some people erroneously label as ECG, but that’s incorrect; ECG and EKG both refer to electrocardiograph and are interchangeable.
    Isn't that typically referred to as an Echo?
    edited September 2018
  • Reply 13 of 19
    lkrupp said:
     but that cheesecake is beckoning me.
    You of course meant - baconing you... 
    king editor the gratetoysandmejony0claire1
  • Reply 14 of 19
    Soli said:
    cecil444 said:
    TrueNorth said:
    Isn't EKG different from ECG?
    According to Google, the answer is no.  The K is the from German version of cardiac.
    There’s also an echocardiogram, which is a different thing and which some people erroneously label as ECG, but that’s incorrect; ECG and EKG both refer to electrocardiograph and are interchangeable.
    Isn't that typically referred to as an Echo?
    No, they are quite different.
    An electrocardiogram measures the electrical signal coming from the heart.   Obviously the the single lead can determine heart rate and rhythm.  A full 12 lead can determine a whole lot more -- even if you've had a prior heart attack.  
    An echocardiogram is a doppler echo like they use to see a baby in the womb.   It can image the actual heart beating and determine its pumping capacity, wall thickness, etc....
    jony0
  • Reply 15 of 19
    SoliSoli Posts: 9,261member
    Soli said:
    cecil444 said:
    TrueNorth said:
    Isn't EKG different from ECG?
    According to Google, the answer is no.  The K is the from German version of cardiac.
    There’s also an echocardiogram, which is a different thing and which some people erroneously label as ECG, but that’s incorrect; ECG and EKG both refer to electrocardiograph and are interchangeable.
    Isn't that typically referred to as an Echo?
    No, they are quite different.
    An electrocardiogram measures the electrical signal coming from the heart.   Obviously the the single lead can determine heart rate and rhythm.  A full 12 lead can determine a whole lot more -- even if you've had a prior heart attack.  
    An echocardiogram is a doppler echo like they use to see a baby in the womb.   It can image the actual heart beating and determine its pumping capacity, wall thickness, etc....
    Why the are you bringing up electrocardiogram in a reply that clearly references echocardiogram? If echo isn't a common shorthand for echocardiogram then you should address that.
    edited September 2018 lolliver
  • Reply 16 of 19
    Soli said:
    Soli said:
    cecil444 said:
    TrueNorth said:
    Isn't EKG different from ECG?
    According to Google, the answer is no.  The K is the from German version of cardiac.
    There’s also an echocardiogram, which is a different thing and which some people erroneously label as ECG, but that’s incorrect; ECG and EKG both refer to electrocardiograph and are interchangeable.
    Isn't that typically referred to as an Echo?
    No, they are quite different.
    An electrocardiogram measures the electrical signal coming from the heart.   Obviously the the single lead can determine heart rate and rhythm.  A full 12 lead can determine a whole lot more -- even if you've had a prior heart attack.  
    An echocardiogram is a doppler echo like they use to see a baby in the womb.   It can image the actual heart beating and determine its pumping capacity, wall thickness, etc....
    Why the are you bringing up electrocardiogram in a reply that clearly references echocardiogram? If echo isn't a common shorthand for echocardiogram then you should address that.
    Stop trolling me you idiot.
  • Reply 18 of 19
    claire1claire1 Posts: 510unconfirmed, member
    Apple amazes again! They're on a roll this year!!
    watto_cobra
  • Reply 19 of 19
    ivanhivanh Posts: 380member
    ECG feature, read a recent article from NewScientist that scientists are warning that consumer using ECG features may risk their lives more because more patients will be prescribed with blood thinner medication unnecessarily. And Apple has no measure at all to prevent false alarm.  See “New Apple Watch’s potential risks”, Clare Wilson, on 22nd September 2018, NewScientist.
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