Mobile heart monitor receives 510(k) clearance, CE Mark

SAN FRANCISCO, CA – AliveCor, Inc. has announced the 510(k) clearance and CE Mark approval of its mobile Heart Monitor, a clinical-quality, low-cost mobile ECG heart monitor, compatible with the iPhone 4 and 4S.

The AliveCor Heart Monitor is a case that wirelessly connects to the iPhone to send one-lead electrocardiogram data. It is powered by a 3.0V coin cell battery. It is now available for pre-order on AliveCor’s website for $199. It is intended for use by licensed medical professionals to record, display, store, transfer, and evaluate ECG rhythms. A similar ECG designed for use by veterinarians and pet owners came out earlier this year.

The device enables quick, easy, and remote access to one-lead ECG and heart rate data. The company hopes to produce a consumer version that may be “prescribed” and potentially sold at a lower price.