Send ECGs Via Smartphone? AliveCor Says Yes - InformationWeek

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Send ECGs Via Smartphone? AliveCor Says Yes
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anon0001020045
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anon0001020045,
User Rank: Apprentice
1/13/2014 | 4:38:21 AM
That's Great!
SMart phone technology is grwoing very rapidly and there is no doubt that, it has great features, which are increasing day by day.
Ken Terry
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Ken Terry,
User Rank: Apprentice
11/27/2013 | 10:39:20 AM
Re: phone updates?
As far as I know, once the FDA approves a medical device and/or an app that turns a smartpphone into a medical device, it's good to go. I don't think a vendor needs to re-apply when it adds Android or Windows phone capability to iPhone capability, e.g. The AliveCor system includes both the mobile device and the app, so they must have been approved concurrently.
Andrew Froehlich
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Andrew Froehlich,
User Rank: Moderator
11/27/2013 | 10:31:21 AM
phone updates?
Hi Ken -- thanks for the informative read. I know that the FDA recently approved smartphones and apps to be regulated in one of two categories...the first being more informative health information, while the second could cause the patient harm if the device doesn't properly work. I'm guessing that the ECG app falls into the first category and is therefore not held to the high standards of other medical devices. Do you have any information if app developers want to design category 2 devices? I just wonder how OS and app updates would be handled. Normally, these applications whould have to be re-certified by the FDA...and since mobile apps and operating systems change so frequently, I don't see how that's even possible.


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