What’s Next for the iPhone ECG Following Regulatory Clearance?

Posted in Mobile Health by Brian Buntz on December 7, 2012

The user base and functionality of mobile ECG technology is set to expand.

After recently winning FDA clearance and CE Mark certification, the iPhone ECG from AliveCor (San Francisco, CA), is poised to kickstart a disruption of the traditional ECG market. The device, although not intended to replace traditional 12-lead ECG testing, is making heart monitoring technology more pervasive and mobile. “Our aspiration is that the ECG should be as accessible to you as your blood pressure,” said the company’s president and CEO Judy Wade in an interview with MD+DI. “Our vision overall is that everyone should have their health at their fingertips. And by everyone, we mean globally everyone.”

AliveCorCardiovascular disease remains the leading cause of death globally, according to the World Health Organization, and 82% of those deaths occur in low- and middle-income countries. In many of these countries, many people never or rarely visit a doctor. Nevertheless, three quarters of the world’s population already has access to cell phones.

At present, the company is focusing first on the domestic market. iPhone ECG is available for U.S. medical (and veterinary) professionals on the iPhone 4 and 4S. The unit consists of a case with two electrodes on the back that detect ECG data and convert it to ultrasonic FM sound signals that are transmitted to the microphone of the iPhone. New form factors that can accommodate other types of mobile devices are in the works.

“Our goal is to make this technology universally available for the prescription use as well as for over-the-counter use,” Wade says. “In January, we’ll announce the timing of both of those next steps.” Commercializing an over-the-counter consumer version will require that FDA approves a 510(k) filed for that application.

The above image was drawn from a teardown report for the AliveCor Veterinary Heart Monitor AC-002. The case for this unit is identical to the human version, which recently obtained regulatory clearance. The monitor consists of two electrodes that come in contact with the patient's skin in order to obtain the ECG waveform. As the TechInsights report explains, the output ECG signals from the device are converted to ultrasonic FM sound signals that are transmitted through an audio transmitter to the microphone of the iPhone, where it is processed and displayed by the iPhone.

The company already has a veterinary product available in Europe; a human version will be made available for that market in 2013. Wade says the technology’s low cost and the fact that the information it generates is stored in the cloud bode well for its global adoption.

As is the case with many disruptive technologies, the iPhone ECG has attracted both adulation and skepticism; so far, the former has predominated. The device has won endorsements from famous clinicians such as Eric Topol, MD; Leslie Saxon, MD; and NIH chief Francis Collins, MD. High-profile investors Vinod Khosla and G. Steven Burrill are also fond of the device, sometimes showing it off in public.The unit has been validated in a clinical study against the Mac5500 12-lead ECG from GE Healthcare.

But for all the buzz surrounding the device, it has attracted some skepticism as well. For instance, an over-the-top Gizmodo piece pokes fun at the notion of a doctor using an iPhone to check a patient's heart health. On MedCity news, a mostly positive piece by Westby G. Fisher, MD, acknowledges the potential challenges that lie ahead in “deploying this device on the general public.”

Similar dialogue has surrounded many disruptive innovations, which as Harvard Business School professor and author Clayton Christensen has explained, are initially characterized by lower performance than that of the broader market. For instance, when the cell phone debuted, it had worse sound quality than either landlines or payphones. As the sound quality and functionality of the devices greatly improved and the price dropped, payphones have nearly become extinct and use of landlines is plummeting.

That’s not to say the iPhone ECG will eventually make the 12-lead ECG obsolete. But as Dr. Fisher points out in the aforementioned article, “for doctors and medically-savvy patients, this device is a game-changer.” The device is substantially less expensive and easier to use than conventional ECG devices and, at $199, the iPhone ECG is a fraction of the cost of a traditional ECG unit. Because of those factors, it makes way for the doctors who own the device to use it in public locations such as airplanes and shopping malls. In fact, the device has already been used in the former scenario. In November 2011, Topol used the device to diagnose a myocardial infarction while on a plane en route from Virginia to San Diego. The plane made an emergency landing and the patient survived the ordeal.

AliveCor is also exploring algorithm-based ECG detection technology that could be validated by a physician to more accurately detect atrial fibrillation (AF), which dramatically elevates the risk of stroke. In a recent study titled “Validation of an iPhone ECG Application Suitable for Community Screening for Silent Atrial Fibrillation: A Novel Way to Prevent Stroke,” the automated algorithm had an accuracy of 97%. The study concluded that the device could have “a substantial impact on reducing ischemic stroke related to previously undiagnosed AF.” Wades explains that using algorithms in conjunction with the mobile ECG technology is “evidence of [the company’s] aspiration overall.”

The field of computer-assisted diagnosis, which has existed for decades, is picking up steam.

The field of computer-assisted diagnosis, which has existed for decades, is picking up steam. IBM is working to harness the Watson artificial intelligence computer system's ability to understand natural language, solve complex problems, and continually learn from massive data sets to improve diagnoses. Only recently, Silicon Valley-based startup Scanadu announced its plans to commercialize a trio of home diagnostic devices.

The field of smartphone-based automated ECG interpretation is also gaining momentum. Last year, the PhysioNet/Computing in Cardiology Challenge was announced to develop an ECG algorithm that can run in near real-time on a smartphone and provide diagnostic information that could be understood by a layperson.

Wade says she is excited by the long-term prospects of recording and analyzing peoples’ ECGs. “What we see is our ability to take deep data around electrocardiograms that we can contextualize with user behavior data,” Wade says. She explains that the system to do this would be HIPPAA-compliant and would synthesize ECG and other health metrics and clinical trial data to “provide deep insight and services for cardiac health.” Such a system could be used, for instance, to determine what is triggering an arrhythmia or to observe the heart growing stronger over time in response to exercise.

The company also plans to partner with Saxon to develop the project, an online network that will store medical data harnessed from smartphones. “We see Leslie Saxon as a key partner and we are absolutely excited to contribute and working with her on that overall vision of,” she says.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz


For more on the iPhone ECG, check out the “Ahead of His Time” series of MD+DI articles:


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