AliveCor receives first FDA clearance to detect a serious heart condition in an ECG on a mobile device


AliveCor has announced that the US Food and Drug Administration (FDA) has granted the company clearance for its algorithm to detect atrial fibrillation, the most common form of cardiac arrhythmia. AliveCor’s automated analysis process (algorithm) instantly detects if patients are experiencing atrial fibrillation through real-time electrocardiogram (ECG) recordings taken on the mobile phone based AliveCor Heart Monitor, so physicians can intervene before potentially life-threatening conditions, like strokes, occur. Through AliveCor’s ECG analysis service, patients can confirm their results with a US board-certified cardiologist or a personal physician.

“The ability to automatically detect serious heart arrhythmia using mobile technology has the potential to save lives, reduce healthcare costs and allow patients and their caregivers to make informed decisions about cardiac care,” says Euan Thomson, president and chief executive officer of AliveCor. “Having achieved clearance, we will work to incorporate the algorithm in our app and plan to make this available to customers during September.”

One in four adults over age 40 develops atrial fibrillation, making them five times more likely to have a stroke. Atrial fibrillation can be hard to detect, as symptoms, including heart palpitations, may be mild or non-existent. The Atrial Fibrillation Detector represents a major step in the advancement of mobile phone based health, allowing patients to instantly know if atrial fibrillation is present in their ECG. The company hopes to collect additional data and develop other algorithms over time.

“AliveCor is truly delivering on the promise of mobile health, placing medically relevant, intelligent tools in the hands of consumers worldwide,” says Trudie Lobban, founder and chief executive officer of AF Association & Arrhythmia Alliance. “We are excited about this milestone and look forward to using this technology to help those who suffer from arrhythmias identify when atrial fibrillation is present in an effective and efficient way so they can work with their doctors to manage their condition.”

The AliveCor Heart Monitor is intended to record, store and transfer electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation (when prescribed or used under the care of a physician). The AliveCor Heart Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The AliveCor Heart Monitor is compatible with all iPhone models and most Android mobile devices. Users will continue to have the ability to access their data confidentially anytime, anywhere.