FDA And CE Nod For AliveCor’s Heart Monitor For iPhone

In short

AliveCor, Inc. has taken the opportunity presented by the 4th annual mHealth Summit in Washington, D.C. to announce the FDA 510(k) clearance and CE marking of its mobile Heart Monitor.

The company says its clinical-quality, low-cost mobile ECG heart monitor, compatible with the iPhone® 4 and 4S, enables doctors to evaluate patient heart health easily, quickly and remotely.


AliveCor’s Heart Monitor is initially intended for use by licensed medical professionals to record, display, store, transfer, and evaluate single-channel electrocardiogram (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 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.

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. Atrial fibrillation is the most commonly occurring arrhythmia and carries a five-fold increased risk of stroke.

Additionally, AliveCor’s founder, Dr. David Albert, and co-founders Bruce Satchwell and Kim Barnett were granted U.S. Patent No. 8,301,232 for the device and technology.

Company comments

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

“Our goal is to make health care cheaper, easier and more readily available without losing quality of care,” said AliveCor President and CEO Judy Wade. “Our aspirations are significant; we’re out to make a real difference.”


AliveCor’s Heart Monitor is available for pre-sale to medical professionals in the U.S., beginning today, through the company website, www.alivecor.com. The cost is $199. AliveCor plans to begin selling the Heart Monitor in Europe in early 2013.

iPhone® is a trademark of Apple Inc., registered in the U.S. and other countries.

Source: AliveCor, Inc., Business Wire