AliveCor’s Kardiaband EKG reader becomes first Apple Watch accessory to win FDA approval as a medical device

“The Food and Drug Administration has just cleared AliveCor’s Kardiaband EKG reader [US$199 with $99 annual subscription] as the first medical device accessory for the Apple Watch,” Sarah Buhr reports for TechCrunch. “Europe has been able to use a version of the Kardiaband for Apple Watch for some time now but, thanks to the new FDA approval, the device can now be used in the U.S., marking the first time an Apple Watch accessory will be able to be used as a medical device in the States. You can get an EKG reading continuously and discreetly just by touching the band’s integrated sensor.”

“Along with the new Kardiaband for Apple Watch announcement, AliveCor is introducing a software feature called SmartRhythm, which uses a deep neural network to give you insight into your heart rate and can potentially detect an abnormal heart beat using the Kardiaband or KardiaMobile EKG reader,” Buhr reports. “EKGs are usually only available in offices and hospitals — and only after a life-threatening event. Having one on your wrist that you can use to check your heart and then send a readout straight to your doctor is vital to prevention of a heart attack or stroke.”

“AFib is the most common heart arrhythmia, and a leading cause of stroke. In fact, one in four adults over the age of 40 could be at risk,” Buhr reports. “‘This is a medical device. This is not a toy that says your heart might be irregular. This is an FDA-cleared device. It’s one of the hardest things I’ve ever done in my life,’ [AliveCor CEO Vic] Gundotra said.”

Read more in the full article here.

MacDailyNews Take: This is a big deal for both companies. For Apple, it reinforces the fact that Apple Watch is a sophisticated wearable computer.


  1. It’s strange to me that this band communicates with the Apple Watch by high pitched audio. Can’t it use the watchband-covered data slot? Has Apple not made that available? If not, is this approved by Apple? Might they block the implementation at some point by disallowing the passing of data by audio? Also what about household pets or other animals? Will they be affected by this?

    1. My guess (since Bluetooth would have been an option) is that FDA approval eliminated BT for either reliability or interference reasons. From an engineering perspective — sound is easy, analog, and energetically *very* cheap.

    2. They’ve been selling a device that attaches to the back of your iPhone for several years now, and it uses the same method. Works great. Yes, FDA approved as a single-trace EKG. As for Apple, I’m pretty sure this was one of the devices they highlighted when they first focused upon health apps with the iPhone. Probably why I first got it. As for your pets, they’re approved to take the EKG of your pets too, so I doubt they’re bothered.

    1. I have seen hundreds of patients with diabetes who use FDA-approved serum glucometers with constant foot infections, chronic osteomyelitis, amputations, on dialysis, sufferers of heart disease and stroke. It is pathetically ignorant to conclude that use of a FDA-approved device has improved the length and quality of there lives. A device only allows people to measure the rate and extent of disease progression – a device is not a cure, it’s a daily chronicle of morbidity.

      1. Apple Watch sends message to physician when patient expires from arrthymia. That’s helpful. Now physicians can pin point time of death. Even if Apple Watch sends a message does the physician receive it in time? Does the patient make it to the hospital in time? There are multiple critical variables that determine patient outcomes and Apple Watch is not the major one.

  2. $199 for 42mm Apple Watch on Amazon…..$99 per year monitoring fee…®-KardiaBand-Wearable-Wristband-Evaluate/dp/B01N1I34W5/ref=sr_1_2_a_it?ie=UTF8&qid=1512053222&sr=8-2&keywords=kardia%2Bband&th=1

  3. OK, you pay the cost of Apple Watch plus $200 and then $100 per year. For people with heart problems, that’s a very small price to pay for improving the quality of their life, getting early warning of problems developing and providing peace of mind.

    This sounds like quite a bargain.

  4. I’ve had the AliveCor monitor that sticks to the back of your iPhone for several years now, and it’s great. Easy to use every day. Any funny readings, you can send in for a pro to read, and it’s cheap and fast. If you don’t need constant monitoring, get the $75 AliveCor that sticks to the back of your iPhone. If you need constant monitoring, the new AppleWatch device may be your best bet.

  5. It’s worth seeking out some of the more detailed accounts where Vic Gundotra explains the hurdles that were needed to overcome in order to get FDA approval.

    He described it as the hardest thing he has ever had to do and to boil it down to the essentials, in his previous careers ( at Microsoft an then Google ), he was used to getting away with making unsubstantiated claims and releasing unproven stuff to be refined later. What came as such a shock was the FDA’s requirement that everything had to be proven scientifically and exhaustively tested.

    He said “They don’t care about your word. They care about clinical evidence. You have to follow their process and don’t fool around with them. As a tech executive, it took me a year to make some mistakes and learn. I’ve been humbled through the process, but hey, we did it, we got there,”

    That was clearly quite a culture shock for somebody with a Microsoft/Google background discovering that they had to scientifically prove that they can really deliver what they’re claiming to do within an environment where bullshit counts for nothing.

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