First Wireless Smartphone ECG Successful in Monitoring Patients

Study results presented in poster presentation at the American College of Cardiology


April 6, 2012

April 6, 2012 — AliveCor, developer of the mobile electrocardiogram (ECG) recorder, announced results from a study that demonstrated how the company’s ECG monitoring device is intuitive and allows users to learn and characterize their heart rates by using the hand-held device in their hands or on their chest. The data from the credit-card-sized wireless device is designed to help physicians and healthcare providers monitor and assess their patients’ heart health for a variety of medical reasons.

The AliveCor smartphone ECG is an investigational medical wireless device that incorporates electrodes into a wireless case that snaps onto the back of a smartphone, allowing for wireless single-lead recording of 30-second rhythm strips that are stored securely in the cloud and the device itself. The ECGs are wirelessly downloaded for immediate interpretation using a variety of browsers, and the device is designed to work in conjunction with a range of mobile platforms, including iPhone, iPad and Android devices.

The results from this study were presented in a poster presentation at the American College of Cardiology (ACC) 61st Annual Scientific Session in Chicago by David Albert, founder and chief medical officer of AliveCor, and Leslie Saxon, chief division of cardiovascular medicine, USC Keck School of Medicine, and the director of the Center for Body Computing at USC.

“The implications of this technology for improving public awareness of health metrics and for early diagnosis of arrhythmias could be beneficial for physicians, their patients and for payers. Current monitoring systems for diagnosing arrhythmias are cumbersome, result in an inefficient use of health care resources, are subject to inaccuracy due to lack of patient compliance and fail to reach many patients who need better monitoring,” said Albert.

The eight-week study, “iPhone Rhythm Strip: Clinical Implications of Wireless and Ubiquitous Heart Rate Monitoring,” enrolled 54 participants to determine how they use the device and were reviewed daily by Saxton, the principal investigator.

After using the device, 24 percent of subjects reached out to their private physicians for a consultation and 16 percent felt that they discovered a health condition previously unknown to them. Seventy-five percent of participants requested continuation of the device usage after the eight-week study period. Thirty-three percent felt that they were more health conscious after participating in the study and 88 percent thought that the device was transmitting accurate information. Participants indicated that they found the portability, ease of use and the form factor to be key aspects of the device that were most conducive for use.

“The study provided us with important information required to optimize the device for physician and patient application,” said Saxon. “This device, incorporated into smartphones and tablets, provides physicians and their patients with a clinical-quality, low-cost heart monitor that will increase the global availability of advanced cardiac monitoring.”

The company is currently underway in clinical studies at the Oklahoma University Health Sciences Center and is seeking regulatory clearance for marketing approval of its iPhone ECG Case and Android ECG Card.

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