The U.S. Food and Drug Administration (FDA) has granted AliveCor clearance to sell technology that enables an iPhone or Android smartphone phone to record atrial fibrillation (AFib), the most common form of cardiac arrhythmia or an irregular heartbeat.
AliveCor's Heart Monitor comes as an iPhone case with two electrodes that can detect a heart rate when gripped by both hands of a user. An automated analysis process (algorithm) instantly detects if patients are experiencing AFib through real-time electrocardiogram (ECG) recordings taken on the mobile phone based AliveCor Heart Monitor.
"Having achieved clearance, we will work to incorporate the algorithm in our app and plan to make this available to customers during September," AliveCor CEO Euan Thomson said in a statement.
AFib is most commonly caused by abnormalities such as high blood pressure, coronary artery disease, heart attack, heart valve disease or cardiomyopathy.
AFib may have no symptoms, but it is often associated with heart palpitations, fainting, chest pain, or congestive heart failure. The risk of stroke is increased fivefold in individuals with AF. One in four adults over age 40 develop AFib, making them five times more likely to have a stroke.
Scripps Translational Science Institute conducts clinical trials on digital health technology, including AliveCor's Heart Monitor device.
Dr. Eric Topol, chief academic officer of Scripps Health and director of the Scripps Translational Science Institute, said in an email to Computerworld that he has been using the AliveCor ECG device on his own patients for several years. Topol even used it twice during airline flights to diagnose passengers experiencing chest pain. The last time that happened, in March of 2013, he used the device to diagnose AFib in a female passenger.
"It's a positive step, since atrial fibrillation is the most common serious heart rhythm, Topol said. "This will get done (analyzed) automatically when the ECG tracing is obtained. We still need to get all of the other major heart rhythms to be auto-diagnosed via algorithms."
AliveCor said it expects to collect additional data from its new algorithm and develop other algorithms for detecting other health conditions over time.
"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," Thomson said.
The AliveCor Heart Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals.