FDA approves iPhone ECG monitor

Reed Miller

December 03, 2012

San Francisco, CA - AliveCor's iPhone-compatible single-channel ECG monitor will soon be available in the US and Europe now that the Food and Drug Administration has cleared the 510(k) for the device and the EU has granted it a CE mark, the company announced [1].

AliveCor Heart Monitor [Source: AliveCor]

The AliveCor monitor is in a thin case with two electrodes that snaps onto the back of an iPhone 4 or 5. To obtain an ECG recording, the patient just holds the device while pressing fingers from each hand onto the electrodes. The device can also obtain an ECG from the patient's chest. The AliveCor ECG iPhone app can record rhythm strips of any duration to be stored on the phone and uploaded securely to the cloud for later analysis, sharing, or printing through AliveCor's website. It will operate for about 100 hours on a 3.0V coin cell battery, the company says.

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