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AliveCor heart monitoring smartphone case cleared by FDA

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December 6, 2012

The AliveCor Heart Monitor attaches to the back of an iPhone 4 or 4S

The AliveCor Heart Monitor attaches to the back of an iPhone 4 or 4S

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AliveCor’s smartphone Heart Monitor has received FDA approval and will go on sale to healthcare professionals in the United States in January 2013. The AliveCor Heart Monitor allows the recording, display, storing, transferring, and evaluation of single-channel electrocardiogram (ECG) rhythms using an iPhone 4 or 4S.

The Class II medical device consists of a self-powered case that attaches to the back of an iPhone, which is running the associated heart monitor app. The phone and case communicate with one another wirelessly, though the phone doesn't need to be paired to the device. To generate a Lead I ECG, the patients rests the fingers of each hand on the electrodes on the rear of the device and, once the connection is made, the app monitors and records heart rhythms and rates for evaluation.

Clinical studies have shown an accuracy of the device in single-channel ECGs of 94 to 100 percent. The company is continuing research on the device regarding its effectiveness in monitoring post-ablation follow up, long-term atrial fibrillation monitoring, multi-specialty care integration, medication-induced QT duration response monitoring, expanding PA/RN data collection abilities. preventive pediatric care and stress induced rhythm morphology changes.

The AliveCor Heart Monitor is priced at US$199 and is currently available for pre-order for U.S. customers ahead of the January 2013 release date.

Source: AliveCor via Dvice

About the Author
David Szondy David Szondy is a freelance writer based in Monroe, Washington. An award-winning playwright, he has contributed to Charged and iQ magazine and is the author of the website Tales of Future Past.   All articles by David Szondy
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2 Comments

Since this is a case for an iPhone (excludes iPod, iPad, etc), I think the manufacturers should look at this article which shows 68% of the smartphone market belongs to Android.

http://money.cnn.com/2012/08/08/technology/smartphone-market-share/index.html

chomper
7th December, 2012 @ 10:17 am PST

chomper,

So which Android device are they supposed to build it for? Have you ever wondered why there isn't much of an Android hardware add-on market other than separate devices that connect with Bluetooth? There's over a hundred different devices, each with different physical dimensions. At least with iOS, there are only a few devices to target.

Although this isn't designed well. They mention all sorts of long-term monitoring, which would be better done with a Bluetooth chest belt, which is something that actually could be designed to work with all Android devices and iPhones and iPod touches of all generations. You can't hold a smartphone in two hands for long intervals and still get anything else done.

Gadgeteer
9th December, 2012 @ 11:01 pm PST
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