AliveCor obtains FDA clearance for arterial fibrillation algorithm

21 August 2014 (Last Updated August 21st, 2014 18:30)

The US Food and Drug Administration (FDA) has given its clearance for AliveCor’s automated analysis process (algorithm) to detect atrial fibrillation (AFib).

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The US Food and Drug Administration (FDA) has given its clearance for AliveCor's automated analysis process (algorithm) to detect atrial fibrillation (AFib).

AFib is a common condition of cardiac arrhythmia, which is seen in among one in four adults aged more than 40 years.

The condition is hard to detect as symptoms such as heart palpitations may be mild, making the patients more vulnerable to heart attacks.

The AliveCor's algorithm can easily find whether the patient is suffering with AFib through real-time electrocardiogram (ECG) recordings taken on mobile phone-based AliveCor Heart Monitor platform.

This allows physicians to instantly act and prevent the occurrence of life-threatening conditions such as heart strokes.

AliveCor president and CEO Euan Thomson said: "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.

"The AliveCor Heart Monitor not only detects the presence of AFib, but can also record, store, transfer and display electrocardiogram rhythms."

"Having achieved clearance, we will work to incorporate the algorithm in our app and plan to make this available to customers during September."

The AliveCor Heart Monitor not only detects the presence of AFib, but can also record, store, transfer and display electrocardiogram rhythms.

AF Association and Arrhythmia Alliance founder and CEO Trudie Lobban MBE said: "AliveCor is truly delivering on the promise of mobile health, placing medically relevant, intelligent tools in the hands of consumers worldwide.

"We are excited about this milestone and look forward to using this technology to help those who suffer from arrhythmias identify when AFib is present in an effective and efficient way so they can work with their doctors to manage their condition."

The AliveCor platform is compatible with all iPhone models and most Android mobile devices.


Image: AliveCor's Heart Monitor application on mobile device. Photo: courtesy of PRNewsFoto / AliveCor.