FDA clears Heart Monitor for iPhone

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AliveCor announced at the 4th annual mHealth Summit in Washington, DC, USA, that the company received FDA 510(k) clearance on its mobile Heart Monitor as well as CE mark conformity. The Heart Monitor is initially intended for use by licensed medical professionals to record, display, store, transfer, and evaluate single-channel electrocardiogram (ECG) rhythms. The device is compatible with the iPhone 4 and 4S.

Clinical studies of the device indicate that a high-quality single-channel ECG can be rapidly and simply recorded using an iPhone with the AliveCor application and device, to accurately screen for cardiac arrhythmias.

Additionally, AliveCor’s founder, David Albert, and co-founders Bruce Satchwell and Kim Barnett were granted US Patent No. 8,301,232 for the device and technology. The three colleagues began working on the heart-monitoring device in 2008.


“We believe that mobile ECGs and other breakthroughs in mobile health can significantly change the way medicine is delivered,” said Albert.


The rhythm strips can be of any duration, and are stored on the iPhone and securely in the cloud for later analysis, sharing and printing through AliveCor’s secure website. The ECG data is sent wirelessly from the Heart Monitor via AliveCor’s low-power, proprietary communication protocol, and requires no pairing between the iPhone and the device.


The device incorporates electrodes into a case that snaps onto the back of an iPhone 4 or 4S. The Heart Monitor is used by launching the corresponding AliveECG app on the iPhone, holding the device in a relaxed state, and pressing fingers from each hand to each of the two appropriate electrodes on the device. The device can also be used to obtain an ECG by placing it on the chest.

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