Smartphone App Will Enable Patients to Detect Atrial Fibrillation

The US Food and Drug Administration (FDA) recently approved a new algorithm that will enable many smart phones to detect signs of atrial fibrillation (AF).

AliveCor’s heart monitor combines the free AliveEKG app with a $199 cellphone case that comes with sensors built into the back. Users put the first two fingers from one hand on one of the sensors and the first two fingers from the other hand on the second sensor. The device then measures electrical signals that are transmitted from the heart and through the fingers.

When the app that drives the system is updated to include the new algorithm, it will be able to detect patterns in the electrocardiogram (ECG) that indicate AF. When it detects such patterns, the software will notify the user, who can then send the ECG reading on to any or all of three places: his or her own doctor, an AliveCor technician who will provide an almost immediate analysis or a medical group in Los Angeles, where a board-certified cardiologist will (for $12) read it within 24 hours.

“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,” said Euan Thomson, president and chief executive officer of AliveCor, in a news release. “Having achieved clearance, we will work to incorporate the algorithm in our app and plan to make this available to customers during September.”

The FDA does not regulate or monitor devices and software that claim to provide basic information about things like heart rate or distance jogged. It does, however, evaluate next generation products that offer “actionable” health data, products that might prove dangerous if they don’t work as advertised.

AliveCor says the FDA based its approval, in part, on data from the 6,000 people who already use the company’s heart monitor, which is currently available for 6 Apple devices, 4 Android phones from Samsung and 1 Android phone from HTC.

Many of those users have chosen to contribute their readings so the company can look for significant patterns and keep improving the product.

Even before the approval of the new algorithm, many doctors had been using ECG readings from the system to diagnose AF, simply by advising high-risk patients to buy the device and reading the results of a month’s worth of ECGs at each appointment.

By automating the analysis, at least in part, the algorithm should reduce the delay between the first signs of AF and its diagnosis. Under the old system, a month or more might elapse between a suspicious ECG and the routine appointment that would alert doctor and patient. The algorithm, on the other hand, will sound the alert immediately, and the extra speed may well prove significant.

“AliveCor is truly delivering on the promise of mobile health, placing medically relevant, intelligent tools in the hands of consumers worldwide,” said Trudie Lobban MBE, Founder & CEO 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 AFib is present in an effective and efficient way so they can work with their doctors to manage their condition.”\