By Shiv Gaglani

The AliveCor heart monitor is perhaps the most iconic device symbolizing the digital health movement. It is frequently cited by many of the clinical leaders who are leading the transition into data-driven mobile health, including CNN’s chief medical correspondent Sanjay Gupta, USC cardiologist Leslie Saxon, and Scripps cardiologist Eric Topol. I first became acquainted with AliveCor and its founder, cardiologist David Albert, MD, in 2011 when they were still calling the not-yet-FDA-approved heart monitor the “iPhone ECG.” They have made tremendous progress over the past 2 years, from the perspective of both academic research and commercialization. This includes completing a few successful clinical pilots—most recently, SEARCH-AF—locking up key patents, releasing an improved mobile app, and raising more than $18 million in venture funding. We caught up with Dr. Albert, the former chief clinical scientist at GE HealthCare with more than 30 issued patents, to discuss these developments and what is next on his plate.

Dr. Ben Freedman, professor of medicine and cardiology at the University of Sydney in Australia, had his group perform an atrial fibrillation (AF) screening study in 10 community pharmacies in the Sydney metropolitan area. The pharmacists recorded 30-second ECG rhythm strips using the AliveCor ECG and our automatic AF diagnosis-in-the-cloud capability in slightly more than 1,000 people. The only entry criterion was that the person was older than 65 years.

Of the 1,000 participants, 45 were found to have AF with 35 being previously diagnosed. However, that means 10 (or 1%) of those screened were found to have previously undiagnosed AF. This was very powerful because the University of Sydney group also performed an economic analysis showing that it was cost effective. These data were presented at the annual Cardiovascular Society of Australia and New Zealand scientific sessions. Both the clinical and economic studies have been submitted to major journals. These would be the first published data showing that AF screening could be done in a cost-effective manner in a public setting. That is very exciting news for us.

We have several thousand medical professionals and more than 1,000 patients using our device and we have yet to really begin selling it.

We view this venture as a marathon and not a sprint, but we will be announcing a number of new products and services, which we believe will increase adoption. Of course all of this is dependent on proving clinical value, which is why our clinical trial efforts are so important.

Our product has already received the CE mark and we currently sell it in the United Kingdom and Ireland. We will be exploring distribution partnerships across the European Union as our resources allow.

AliveCor will be introducing various new products and services over the next few months. Those certainly sound like ones we should consider.

In addition to our Enhanced Filter, we introduced an improved menu structure. We continue to try to improve our user experience for both physicians and patients. The advanced noise filtering was developed in response to patients and physicians asking us to make P wave identification easier. It has certainly done that, and given the use of our device in patients with AF, being sure you don’t see P waves is very important.

We don’t comment on our competition. We assume we will have more competitors in the future, and, as with any market, the success belongs to those who deliver the best solutions. Our latest software update and our upcoming products, as well as our clinical validation efforts, demonstrate our efforts to be the leader in personal ECG technology.

While we don’t comment on upcoming products, all you need to do is look at the major clinical issues in cardiology to find areas where we might have research and development efforts—problems like STEMI and congestive heart failure look like opportunities for innovation.

AliveCor wants to bring personal ECG recording and monitoring—and the clinical value it can provide—to medical professionals and patients all over the world. You can be assured we will be delivering on that goal.

Shiv Gaglani is an MD/MBA candidate at the Johns Hopkins School of Medicine and Harvard Business School. He writes about trends in medicine and technology and has had his work published in Medgadget, The Atlantic, and Emergency Physicians Monthly.