AliveCor™ Heart Monitor for iPhone®, a Breakthrough for Community Screening, AF Detection, and Stroke Prevention, Now Available for Sale to U.S. Medical Professionals

The first FDA-cleared mobile device-based ECG monitor now available for purchase allows medical professionals to measure heart rhythm easily, quickly and even remotely. AliveCor’s Heart Monitor, which has been granted FDA 510(k) clearance as well as CE Mark conformity, was demonstrated at Booth #405 at the Boston AF Symposium, January 17-19. The clinical quality device is available for purchase by licensed U.S. medical professionals at www.alivecor.com for $199, and will be available for sale in Europe this spring. The Heart Monitor has been confirmed in clinical studies to accurately measure and detect cardiac arrhythmias including atrial fibrillation (AF). AF is the most common sustained arrhythmia and affects 2.2 million individuals in the U.S. alone. It is common in the elderly; unrecognized AF is estimated to occur in 1–2% of those over 65 and accounts for 10–15% of all strokes per year. A significant proportion of ischemic strokes is due to previously unrecognized AF, which is largely asymptomatic, and may therefore benefit from community screening to detect the arrhythmia. Until now, community ECG screening has not been considered to be a feasible approach for AF detection due to the lack of availability of a convenient, rapid ECG. Dr. Anne Curtis, Charles and Mary Bauer Professor and Chair at University at Buffalo, who recently utilized the Heart Monitor to aid a fellow airline passenger who had fainted, commented, “AliveCor’s Heart Monitor provides an invaluable, convenient tool for detecting arrhythmias. From infrequent episodes of tachycardia to larger-scale community AF-screening and research, the Heart Monitor is a game-changer for physicians.” AliveCor’s Heart Monitor snaps onto the back of an iPhone, like a case, to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms wirelessly with the corresponding, free AliveECG app. No pairing between the iPhone and Heart Monitor is required. Recorded rhythm strips can be of any duration, and are stored in the app and securely in the cloud in PDF format for reviewing, analysis, and printing through AliveCor’s HIPAA-compliant website. ECG data is accessible anytime, anywhere. A recent study, “Validation of an iPhone ECG Application Suitable for Community Screening for Silent Atrial Fibrillation: A Novel Way to Prevent Stroke,” indicated that a high-quality single-lead ECG can be rapidly and simply recorded using an iPhone with the AliveECG application and Heart Monitor device to accurately diagnosis AF. The results were statistically significant with accuracy rates of 94% and 95% for the cardiologists interpreting the raw trace, and 97% for the automated algorithm, which was optimized to enhance sensitivity (sensitivity 98%, specificity 97%). The results were presented at the AHA Scientific Sessions 2012 Conference by Dr. Jerrett Lau, from Sydney, Australia and have been accepted for publication in the International Journal of Cardiology. ----- AliveCor, Inc., a privately held company headquartered in San Francisco, CA, wants everyone to have their health at their fingertips. That's why they make the vital health signs of people around the globe easily visible and actionable, at exceptionally low cost. This improves everything from public health to the lives and possibilities of people all over the world. AliveCor is a trademark of AliveCor, Inc. in the U.S. and other countries. iPhone® is a trademark of Apple Inc., registered in the U.S. and other countries.