This U.S. FDA approval could be a huge deal for Apple

“When Apple Inc. released the Apple Watch Series 3 earlier this year, the company’s aspirations in the field of health became increasingly clear. The Apple Watch was described as ‘an amazing health and fitness companion’ and ‘the ultimate device for a healthy life,'” Danny Vena writes for The Motley Fool. “Several other recent developments point toward a broader entry into personal health, and there’s mounting evidence that this could be Apple’s next big growth area.”

“The U.S. Food and Drug Administration has approved the first medical device accessory for the Apple Watch, the KardiaBand electrocardiogram (EKG) reader by med-tech start-up AliveCor,” Vena writes. “The KardiaBand replaces the original watchband and combines a sensor with an artificial intelligence (AI) app that can detect an abnormal heart rhythm or atrial fibrillation (AFib). This could be the first step of potentially a massive opportunity for the iPhone maker — the healthcare market.”

“The FDA has already enlisted the help of Apple as one of nine companies chosen to participate in a pilot program that seeks to accelerate the process for approving software-based devices and medical apps. The regulator has been reviewing its approach to technology as part of its Digital Health Innovation Action Plan, with plans to ‘modernize the regulatory framework’ and reduce the amount of red tape necessary for the approval of these apps and devices,” Vena writes. “This could be the start of something big.”

Read more in the full article here.

MacDailyNews Take: There’s Apple Watch, a sophisticated, secure wrist-borne computer with the backing of major hospitals, medical researchers, insurance providers, and more. And, then there’s a bunch of toy stupidwatches. The Apple Watch wannabes are roadkill.

AliveCor’s Kardiaband EKG reader becomes first Apple Watch accessory to win FDA approval as a medical device – November 30, 2017
Apple Heart Study launches to identify irregular heart rhythms – November 30, 2017
AliveCor’s Kardiaband EKG reader becomes first Apple Watch accessory to win FDA approval as a medical device – November 30, 2017
Apple Heart Study could turn Apple Watch into a ‘must have’ for millions of patients – September 12, 2017
Apple Watch the most accurate heart rate monitor in new fitness tracker study – May 24, 2017
Apple Watch helps doctors detect the leading cause of heart failure with 97% accuracy – May 12, 2017
Apple patents advanced heart rate monitor for Apple Watch – October 6, 2016
Apple Watch heart rate data vs. Mio dedicated heart rate monitor – May 7, 2015


    1. Most cardiologists ate not aware of this. My doctor was impressed with the less expensive sister product for iphkne called Kardia Mobile. I did an ECG/EKG for him in the office. Kardia Mobile detected AFib for me at home. It may have saved my life.

      Kardia devices perform a songle channel EKG. In a hospital it would be 12 channel (sokething a doctor would trust).

      For a cardiologist to justify heart 24/7 heart monitoring you are looking at a Cardionet device. This device rents for about $5000 for 2-3 weeks.

      1. They also have Holter monitors for 24hr monitoring to catch heart anomalies. The Kardia Mobile is so inexpensive, especially when on sale, I would think anyone with heart issues would get one. My mom has had one for as long as Alivecor has been around, and it’s very accurate. The single-trace, looks just like the multichannel trace she gets at her cardiologists’ office.

        I’m holding off on the Kardia Watchstrap because it only comes in black! My mom is not going to go for that, she’ll stick with her current KardiaMobile. Plus, I’m not sure my mom needs the $99 a year subscription which is mandatory as far as I can tell.

        Why would anyone downvote your comment? Have you upset anyone before? Made any political comments lately?

    2. I think it would be very significant for AppleWatch if Aetna and CVS merge. Aetna is interested in supplying AppleWatches to subscribers and CVS could eventually carry AppleWatches and associated AppleWatch bands for consumers. That would make a rather ready market to move AppleWatches with Aetna offering (supposedly) free or at least partial discounts. It could be an AppleWatch explosion in the making.

      I don’t think any other smartwatch is even close to having such an advantage if CVS stores do become an AppleWatch retailer. Fingers crossed.

      1. Interesting. I couldn’t believe it, but Aetna is actually partnering with Apple. A Sep 27 news release by Aetna shows they are providing 50,000 free Apple Watches to employees. CNBC reports secret meetings with Aetna and Apple to build out all kinds of new apps and health monitoring ideas (blood sugar for example). A year from now it is possible Apple will be working with your HR to provide a huge discount on an Apple watch (if you agree to some “wellness” ideas)..

  1. None of this will matter if people can’t see their photos when Apple releases a new software update until you get to MacOS version x.x.2 or IOS version x.2.x. Yes, it happened to me..

  2. I am wearing a KardiaBand now that I got last week from Amazon on my Apple Watch 3.

    This a great way to keep track of your heart rhythm (if you have a history of heart Afib).

    There is also a cheaper product that works with your iPhone called Kardia Mobile.
    Here is my take on KardiaBand over at Apple Discussions

    Note.. if you have any history of AFib your are NOT eligible to participate in the Stanford Heart Study (you know.. ..the study to see if an Apple Watch can help people with AFib and other maladies? Sigh..)

    1. Seems illogical, and I noticed that odd requirement when I signed my mom up for the Study, but I’m assuming they want to set a population baseline, and not start with a skewed sample, ie those people who are already at risk being drawn to the study; whom presumably are already being treated/monitored.

  3. iHave one as iType attached to my Apple Watch GPS + Cellular. This device IS “GAME” “CHANGING”

    It truly is AMAZING.

    Until you get one …… YOU PEOPLE HAVE NO CLUE.

    My health is THE MOST (#1) important aspect of my life. This band gives me my EKG at the tip of my finger and keeps a log of my heart health. AND more.

    Any questions? Go to the AlivCor website. Apple IS and WILL change the stupidity of our existing healthcare system…. If you can even call it Health Care anymore… More like Government DISEASED EXTORTION.

  4. I am unable to post a web link posted here, but check out my extensive take on this over on apple discussions. Search for KardiaBand.

    The watch (and the mandatory premium service) comes with SmartRythm software fron AliveCor/Kardia. Google image search for SmartRythm. (A picture is worth 1000 words).

    Trivia.. The FDA takes forever to approve something like this. Tested overseas long before the US, the FDA only allows AliveCor to sell the Kardia Mobile and KardiaBand in the US under one very expensive condition (for the manufacturer): for your first use of a Kardia product, a living beathing cariologist must review your first EKG. You will not be able to see your first test result until this occurs. Follow on results will be immediate. It will say “possible AFib”, or “normal sinus”. You can create an account for free and use it on the non watch product.

    Also, it takes some patience and practice to get the band working with the electrode (which has to wirelessly connect to the watch).

    SmartRythm runs in Workout Mode (foreground) on your watch. This uses a lot of power). It is not required to be running for spot checking using the watch band.

  5. Feels a bit wrong to discuss a “coupon” here, but we are fighting heart disease here..

    I just heard Leo Laporte on TWiT mention you can get a 25% discount from the manufacturer (AliveCor) by using code STOPAFIB25 for the Kardia Mobile (and maybe on the KardiaBand). This might help ease the pocketbook (and maybe save you from a life threatening stroke!).

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