First FDA-certified Apple Watch accessory is AliveCor's Kardia Band EKG meter

AppleInsiderAppleInsider
Posted:
in Apple Watch edited November 2017
After a few years of health monitor peripherals availability lacking the Food and Drug Administration's approval, AliveCor's Kardia Band has been approved by the agency, opening up more use of the device in diagnoses of atrial fibrillation in the United States.




Available in Europe for a year and just now released in the U.S., the Kardia Band is activated by the user placing a finger on the sensor pad. The measurement taken across the finger to the Apple Watch facilitates the 30-second EKG reading.

Acoustical signals transmit the reading to the Apple Watch, with it displayed as a waveform on the watch. The data is stored on the connected iPhone.

Clearance granted by the FDA allows the software and hardware combination to advise the wearer that the reading is normal, or possibly an indication of atrial fibrillation.

The subscription service connected to the hardware, SmartRhythm, examines real-time and historical data to predict what is considered acceptable for heart rate readings. Should the user's heart rate exceed that range too many times a day or for a long period of time, the app tells the user to take a EKG reading.

"A lot of my patients already use the credit card sensor, but they don't know when to take an EKG; so they just do it when they feel light-headed or dizzy," Scripps cardiologist Dr. Eric Topol told FastCompany. ""If you can direct them when to do the EKG it's going to markedly increase the number of EKGs taken."

Atrial fibrillation is a change in the normal rhythm of the heart characterized by irregular beat, which is generally imperceptible by the sufferer. The disease is associated with a significantly higher rate of heart failure, stroke, and is linked to dementia as well.

Between two and three percent of North Americans and Europeans are affected by the disease. Four percent of people between 60 and 70 are afflicted, with the number rising to 14 percent of those over 80 years of age.

Atrial fibrillation was responsible for 193,000 deaths in 2015.

AliveCor's Kardia Band is available now for $199, for either the 38mm or 42mm Apple Watch. The Kardia Band replaces the Apple Watch band.

The device requires subscription to AliveCor's premium service for $99 a year, with one free month of service included.

Comments

  • Reply 1 of 11
    technotechno Posts: 737member
    This is where the watch takes a very important path. With more FDA approved devices like this, the value of the Apple Watch significantly improves for the non-fanboys.
    mike1slprescottbshankwatto_cobra
  • Reply 2 of 11
    SendMcjakSendMcjak Posts: 66unconfirmed, member
    Acoustical signals transmit the reading to the Apple Watch, with it displayed as a waveform on the watch. The data is stored on the connected iPhone.
    Do I have this straight?  The band (power source?) uses a speaker to create audio waveforms that carry data to the Apple Watch's microphone?

    So much for the diagnostic port being used for more elegant band--watch data transfer.

    Note to AI:  acoustical signals are transmitted (and, thus, carry) the readings ... super weird to say the "signals transmit"...
    edited November 2017 StrangeDaysjony0
  • Reply 3 of 11
    rogifan_newrogifan_new Posts: 4,297member
    techno said:
    This is where the watch takes a very important path. With more FDA approved devices like this, the value of the Apple Watch significantly improves for the non-fanboys.
    I’m still a bit confused how this is utilizing the Watch. Could they just make a band that communicated with your phone? I think these things will be a tough sell if they add another $200 to the price of an Apple Watch. Unless they’re subsidized by your health insurance company.
    airnerd
  • Reply 4 of 11
    foggyhillfoggyhill Posts: 4,767member
    rogifan_new said:
    techno said:
    This is where the watch takes a very important path. With more FDA approved devices like this, the value of the Apple Watch significantly improves for the non-fanboys.
    I’m still a bit confused how this is utilizing the Watch. Could they just make a band that communicated with your phone? I think these things will be a tough sell if they add another $200 to the price of an Apple Watch. Unless they’re subsidized by your health insurance company.
    Medical devices are very expensive and you'd be surprised how much any one who actually needs it will pay for them.
    Devices that otherwise should cost $100 bucks cost $1000 if they are "FDA approved", so $200 is no biggie.
    This is an area ripe for disruption. Apple taking care of the data management / display / storage means those medical device makers could concentrate on something they're actually good at (the medical aspect) and not everything else, which they are undoubtedly they are not.
    racerhomiemike1libertyforallStrangeDayspscooter63jony0bshankwatto_cobra
  • Reply 5 of 11
    GG1GG1 Posts: 483member
    foggyhill said:
    rogifan_new said:
    techno said:
    This is where the watch takes a very important path. With more FDA approved devices like this, the value of the Apple Watch significantly improves for the non-fanboys.
    I’m still a bit confused how this is utilizing the Watch. Could they just make a band that communicated with your phone? I think these things will be a tough sell if they add another $200 to the price of an Apple Watch. Unless they’re subsidized by your health insurance company.
    Medical devices are very expensive and you'd be surprised how much any one who actually needs it will pay for them.
    Devices that otherwise should cost $100 bucks cost $1000 if they are "FDA approved", so $200 is no biggie.
    This is an area ripe for disruption. Apple taking care of the data management / display / storage means those medical device makers could concentrate on something they're actually good at (the medical aspect) and not everything else, which they are undoubtedly they are not.
    Exactly. Besides the high cost for FDA approval, there is also the long approval time required. Niche medical companies can thrive in this (Apple Watch) environment. These medical "accessories" aren't quickly or easily copied.
    racerhomiemike1watto_cobra
  • Reply 6 of 11
    rogifan_newrogifan_new Posts: 4,297member
    foggyhill said:
    rogifan_new said:
    techno said:
    This is where the watch takes a very important path. With more FDA approved devices like this, the value of the Apple Watch significantly improves for the non-fanboys.
    I’m still a bit confused how this is utilizing the Watch. Could they just make a band that communicated with your phone? I think these things will be a tough sell if they add another $200 to the price of an Apple Watch. Unless they’re subsidized by your health insurance company.
    Medical devices are very expensive and you'd be surprised how much any one who actually needs it will pay for them.
    Devices that otherwise should cost $100 bucks cost $1000 if they are "FDA approved", so $200 is no biggie.
    This is an area ripe for disruption. Apple taking care of the data management / display / storage means those medical device makers could concentrate on something they're actually good at (the medical aspect) and not everything else, which they are undoubtedly they are not.
    Still do you need an Apple Watch for this? Is there some technology this band uses that’s only available with the Watch or when it’s connected to the Watch?
    netrox
  • Reply 7 of 11
    libertyforalllibertyforall Posts: 1,418member
    Love seeing more health products like this, really makes the Watch more purposeful in the future.  Would love to see more health features built in from Apple too.
    watto_cobra
  • Reply 8 of 11
    airnerdairnerd Posts: 693member
    I love the ground breaking nature of this and that it shows companies what is going to be possible, but the data I get from this article is they charge $200 for the band and $100 a year to use the band...and all of that for something that 2-3% of people have.  Of those 2-3% only a small handful are going to actually have an Apple watch, so either this isn't going to make money or they are going to create a whole new medical panic over something that in reality is very uncommon.  Americans in particular are hypochondriacs, look no further than the explosion of gluten allergies.  Very few actually have an allergy.  
    watto_cobra
  • Reply 9 of 11
    StrangeDaysStrangeDays Posts: 12,877member
    techno said:
    This is where the watch takes a very important path. With more FDA approved devices like this, the value of the Apple Watch significantly improves for the non-fanboys.
    I’d hardly claim the current popularity of the AW is attributed to “fanboys”. Nope. It’s very popular with the public at large due to its fitness apps, size, flexible good looks, and notifications. 
    edited November 2017 bshankwatto_cobra
  • Reply 10 of 11
    netroxnetrox Posts: 1,421member
    https://www.alivecor.com pops up as an ad on this page, how convenient. haha and no you don't need a watch for that as they also offer a device to detect your heart rate as well.
  • Reply 11 of 11
    sandorsandor Posts: 658member
    techno said:
    This is where the watch takes a very important path. With more FDA approved devices like this, the value of the Apple Watch significantly improves for the non-fanboys.
    I’m still a bit confused how this is utilizing the Watch. Could they just make a band that communicated with your phone? I think these things will be a tough sell if they add another $200 to the price of an Apple Watch. Unless they’re subsidized by your health insurance company.

    check your health insurance plan - your co-pay for medical devices may exceed $200.

    A-fib patients have a strong desire to have self-monitoring, and, if you already have an Apple Watch, the $200 price point is lower than other more obtrusive self-monitoring devices already available.

    http://www.bpmonitordepot.com/handheld-portable-ecg-ekg/
    http://www.dcbiomed.com/webls-en-us/InstantCheck:V4.0.html
    http://www.theheartcheck.com/consumer.html



    edited December 2017
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