Alivecor announces FDA clearance of EKG band for Apple Watch
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Thread: Alivecor announces FDA clearance of EKG band for Apple Watch

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  1. #1
    Moderator German Watches Forum
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    Alivecor announces FDA clearance of EKG band for Apple Watch

    Alivecor announces FDA clearance of EKG band for Apple Watch

    Your personal EKG on your wrist
    The world's first FDA-cleared EKG with artificial intelligence for Apple Watch®.
    In the system to support this Alivecor offers the KardiaBand ($ 199.00) --> KardiaBand

    * The first of its kind, FDA-cleared, clinical grade wearable EKG replaces
    your original Apple Watch® band providing access to a 30-second EKG
    anytime, anywhere.

    * KardiaBand provides accurate and instant analysis for detecting atrial
    fibrillation (AF) and normal sinus rhythm in an EKG. Simply place your
    thumb on the integrated KardiaBand sensor to take a medical-grade EKG
    in just 30 seconds.

    * Ships with two band lengths to assure a perfect fit.
    KardiaBand contains its own battery to power the EKG electronics.

    Power
    CR1620 battery (included)
    90 hours operational time
    2 years typical use

    EKG Characteristics
    Single Lead ECG
    10 mV peak-to-peak input dynamic range
    30 second recording duration
    300 samples per second sampling rate
    16 bit resolution

    Requirements
    Compatible Apple Watch
    Kardia App

    -


    Thanks,
    rationaltime
    Last edited by rationaltime; November 30th, 2017 at 20:25. Reason: FDA "clearance" vs. FDA "approval"

  2. #2
    HAQ and AW moderator
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    Re: Alivecor announces FDA clearance of EKG band for Apple Watch

    Interesting,but no funds available just to try it out.

  3. #3
    Member BarracksSi's Avatar
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    Re: Alivecor announces FDA clearance of EKG band for Apple Watch

    I'd think its cost would be covered by insurance and/or clinical funds.

    What I haven't learned is what other devices are used for this task. I had a coworker who, on doctor's orders, wore a dedicated chest strap for a couple weeks to check for any heart abnormalities. This AW strap wouldn't achieve the same 24/7 results, but it would gather more detail than the AW's onboard optical HR sensor.

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  5. #4
    Moderator German Watches Forum
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    Re: Alivecor announces FDA clearance of EKG band for Apple Watch

    I don't know about insurance coverage without specific symptoms.

    I expect there are dedicated alternatives, but I don't know that they would
    be much better. I copied the specs for the KardioBand so we could see.
    With a 16-bit ADC and 300 samples/sec the quality should be as good as
    any other single channel EKG. If this could sample continuously it would
    generate sample at the rate of about 50 MBytes/day, which is not much
    in memory use today. The limit must be battery and uploading the data.

    However, I expect there is a bigger issue. A 1st class medical certificate
    requires an EKG (over 40) as does a military flight physical. Those typically
    use multi-channel measurements, but are likely to be similar in this way.
    When the measurements are taken they tell you to relax and lie very still.
    Do not twitch any muscles or they will start over. The muscle nerves firing
    can hide the remote cardiac signal. My guess is the KardioBand one channel
    measurement taken across the wrist to the opposite finger tip is similarly
    sensitive to noise. My guess is continuous measurement is unlikely to be
    useful. To get a clean signal the user may need to stop and relax before
    making a measurement. After a while some member will likely report real
    life experience about this sensitivity.

    I don't know how reliably multi-channel EKG machines predict cardiac
    disease. It seems to me blood chemistry is far more reliable if much
    slower. I expect the EKG is just one indicator. If so the one channel
    measurement may be good enough for predicting some cardiac anomalies.


    Thanks,
    rationaltime
    ronalddheld likes this.

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