FDA Clears AliveCor's Mobile Heart Monitor for iPhone

December 3, 2012—AliveCor, Inc. (San Francisco, CA) announced that it has received 510(k) clearance from the US Food and Drug Administration, as well as CE Mark approval, for its mobile heart monitor. The device is now available for presale online to medical professionals in the United States. AliveCor plans to begin selling the heart monitor in Europe in early 2013.

The AliveCor device is a clinical-quality, low-cost mobile electrocardiography (ECG) heart monitor that is compatible with the iPhone 4 and 4S (Apple Inc., Cupertino, CA), enabling doctors to evaluate patients' heart health easily, quickly, and remotely.

According to the company, 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 including atrial fibrillation.

AliveCor stated that its heart monitor is intended for use by licensed medical professionals to record, display, store, transfer, and evaluate single-channel ECG rhythms. 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 are sent wirelessly from the heart monitor via AliveCor's own low-power 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, the company noted.