Mobile heart monitor receives FDA clearance
AliveCor has received FDA 510(k) clearance on its mobile Heart Monitor as well as CE Mark. This mobile electrocardiogram (ECG) heart monitor is compatible with the iPhone 4 and 4S.
The single-channel ECG can be recorded using an iPhone with the AliveCor application and device, to screen for cardiac arrhythmias including atrial fibrillation, according to the company. AliveCor said its Heart Monitor is initially 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 in the cloud for later analysis, sharing and printing through AliveCor’s website. The ECG data is sent wirelessly from the Heart Monitor via AliveCor’s proprietary communication protocol, and requires no pairing between the iPhone and the device, the company said.
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.
Additionally, AliveCor’s founder, David Albert, MD, and co-founders Bruce Satchwell and Kim Barnett were granted U.S. Patent No. 8,301,232 for the device and technology. The three colleagues began working on the heart-monitoring device in 2008.
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Editor Beth earned a bachelor’s degree in journalism and master’s in health communication. She has worked in hospital, academic and publishing settings over the past 20 years. Beth joined TriMed in 2005, as editor of CMIO and Clinical Innovation + Technology. When not covering all things related to health IT, she spends time with her husband and three children.