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New iPhone ECG App: Interview with Dr. David Albert
In this feature interview, we speak with Dr. David Albert, creator of this new application and device, which was recently showcased at the Consumer Electronics Show in Las Vegas.
Tell us about the components of the AliveCor iPhone ECG.
The iPhone ECG fits the Apple iPhone 4. There are 2 components. There is a case for the iPhone 4 that is as small as any of the cases you would buy to protect your iPhone. It is very sleek and slim, and on the back, it has 2 stainless-steel electrodes about 2.5 inches apart. 
There is also an app that runs on the iPhone. By combining the iPhone app and the case together, you have a real-time, single-lead, cardiac lab recording quality ECG device that comes at an extremely low cost. It turns the iPhone 4 into a clinical quality ECG rhythm diagnostic device. It has the same specifications as any cardiac event recorder that would be prescribed by an EP or cardiologist to a patient with an unknown arrhythmia. It displays the ECG and processes it in real time. It also does beat identification, so it can tell normal beats from ventricular beats, PVCs. It allows the detection of atrial fibrillation after a certain amount of time. In addition to that, it stores all the ECGs on the iPhone itself, as well as transmits it in real time securely to our servers, where you can review it through a web browser — either all the stored files, or you can view it in real time through a web browser.
In addition to the ECG data, it transmits the bpms per patient in real time, the 3X accelerometer data, and the gyroscope data. So you know if the patient is lying down, if they’re standing up, or if they’re sitting.
I’ve been contacted by people at academic medical centers all over the world. The 
cardiology community is literally all awhirl in the US. People see this as a tool they can use to very quickly assess a patient without pulling in an ECG machine and hooking it up. You put it on the patient’s chest and have an instant rhythm diagnosis (for example, if a patient is having runs of ventricular tachycardia or is in atrial fibrillation) literally within 30 seconds. It’s like an ECG stethoscope, which could be very useful for anybody from EPs to family medicine doctors or nurses, to EMTs.
It can also be used by patients to record their rhythm. You can hold it in your hands, and that gives you a standard lead 1 (left arm minus right arm), or you can put it on your chest. So 
you can either get a frontal precordial lead (V1, V2) or you can hold it in your hands and get a standard lead 1. It depends on the patient, but in many people you get very clear P waves if they’re there. Obviously we can put up calipers and do measurements. You can freeze it and measure things like P-R interval or R-R. This is not a device to diagnose an acute MI — it’s not a 12-lead ECG. It’s not a device to look for diagnostic long QT as a result of drugs or some kind of congenital problem. Those require 12-lead ECG. This is not that. This is a very fast, very simple, wireless Internet-connected, inexpensive rhythm assessment device.
What made you come up with the idea to create this product? Why is there a need for such a product?
Well, I’ve been in the area of cardiovascular assessment technology for a long time. Most companies in the ECG business have either licensed my technology or bought it from me. In 2001, GE Healthcare purchased my company, Data Critical. We owned PaceArt, and we owned several different types of technologies, and in 2004, I essentially retired as Chief 
Scientist of GE Cardiology. I was very involved with Guidant, Medtronic, and others. So after I left Duke University, where I was in medical school and biomedical engineering grad school, I spent the 1980s working in research labs with a number of prominent physicians. For example, I worked with Dr. Galen Wagner and Dr. Eric Prystowsky, who are very good friends of mine. So I’ve worked with many of the senior EPs around the country. I’ve been watching this, and I’ve been building and developing technology that’s always more compact, more expensive, and more sophisticated. Clearly we all understand that our healthcare system is under some stress, and cost is a major issue, whether it’s for atrial fibrillation, pulmonary vein ablation, or cardiac resynchronization therapy. All of these are very big public policy issues, not just medical issues. Unfortunate, but true. And so, I sat here and said, how can I improve healthcare, whether it’s in Africa or in a rural village in India, and bring the kind of knowledge I have and the technology I have to be just as valuable in a rural village in Africa as it is at Duke Medical Center?
What I capitalized on was the incredible power of the iPhone. I would say every EP in the 
country has a smartphone today, and relies on it. In the third world, it’s the only technology infrastructure that exists — there’s no running water, there’s no wired telephones, there’s no electricity, there’s only cell phones. That’s it. There are millions of cell phones in China in areas where they don’t even have running water. And it’s the same way in India and in Southeast Asia. So I will tell you that by capitalizing on the power of the smartphone and bringing some relatively clever technology, we are able to bring acute rhythm diagnosis to places where it hasn’t existed before, at a price people can afford.
Then once people are treated, whether it’s with dronedarone, ablation, weight control, or anticoagulation, we’re going to be able to allow those patients to follow themselves at a much reduced cost for the rest of their lives, which we now know is probably mandatory.
How soon before we see one commercially available, and what cost would it be like?
First, the final price of the device hasn’t yet been determined, but I can tell you that it will be a fraction of anything available today, period, because it relies on the smartphone that people already have, so most of the cost is in the iPhone or in the Android phone. So what we deliver will be at a very low cost. Second, the device hasn’t been cleared yet, so we are in the middle of doing the studies and preparing for the FDA to settle. I’ve done many, many FDA studies, and while you can never tell, I think it’s pretty clear to everyone the clinical value of this technology, and as I told you, there’s no compromise on the quality of the ECG. It’s as good as any cardiac event recorder. I’d even go as far as to say it’s better, because we have much more power and can do much more processing than conventional event recorders. So there’s that capability, and then as I said, because it’s on the iPhone, we can wirelessly transmit that ECG to our server, so an EP in a university medical center literally on the other side of the world can be consulting with a primary caregiver somewhere very isolated. This is another very powerful concept, and how that’s delivered is to be determined, but it will be available. The hardware will be available in the second quarter of this year. We hope to have this on the market in the United States by the middle of the year, but that will be dependant on our status with the FDA.
Are there plans to make it compatible with other smartphones?
There is an Android version already working, so it will be for the iPhone first and then Android. I can tell you that when I went to the Consumer Electronics Show, other smartphone manufacturers were very interested in talking with us, as you might imagine. So we’ll be evaluating supporting this technology to other platforms as we believe it’s a smart business move.
What kind of feedback have you received, including at the Consumer Electronics Show?
Well, as I was getting prepared to go to the Consumer Electronics Show, there were 5 companies that told me they were not going to have representatives at the show. So my 11-year-old son, who is a YouTube expert, taught me how to use a webcam to make a video and upload it. So I did that, and I posted the link to that video on my LinkedIn page, which goes to my Twitter account. Well, I only had about 100 Twitter followers, so I didn’t expect anything. However, that evening I had 4,000–5,000 views of that video, and I was shocked! The next morning, I had 25,000 views. Then the website engadget.com picked it up, so I’m up to 170,000 views. I’ve been on CBS, ABC, CNN, and Fox. There have been hundreds of stories all over the world, translated. Cardiologists in the US and from all over the world have been writing me. Doctors have been contacting me to ask when they can have the device.
Of course, I’ve also had about half a dozen people telling me it’s absolutely impossible and a complete fake. But my son said, “Dad, you haven’t really made it until you have your YouTube haters. Now you know you’ve made it!” There’s a blog in Czechoslovakia that one of my partners sent me, and it’s in Czechoslovakian, and these people all talk about how it’s completely fake. They even add that we never landed on the moon, it was done on a stage. So it’s pretty humorous. I guess I should be flattered that they believe what we’ve done is so cool.
We’ve had phenomenal response. We’ve had many cardiologist bloggers cover this. The Heart Rhythm Society (HRS) has tweeted about this device, and they’re going to be doing our clinical trials, including the initial ones here at the University of Oklahoma Medical Center. So it has been very exciting. We’ve got to try to bring our 21st century technology at a reduced cost people can afford without breaking the system, and that was our goal all along.
Tell us about the biofeedback capability.
The device bears a second application that will be available since it doesn’t require FDA approval. The app basically uses clinical-quality ECG and performs beat-to-beat heart rate — in essence, it takes heart rate variability, graphs it on the iPhone screen, and then allows you to listen to relaxation audios through your headphones while you’re getting your immediate heart rate feedback. So I can send you a picture of me putting my heart rate into what we could call a parasympathetic band. Through deep breathing and relaxation, you’re able to allow your parasympathetic nervous system to dominate over your sympathetic nervous system. These are all very well understood techniques. You’re able to lower your heart rate and make the heart rate variability a very narrow band as the vagus dominates over the sympathetic nervous system. It’s useful to all kinds of people who have potentially sympathetic dysarrhythmias. There are such devices available today over the counter, and this will be available as soon as our device ships in the second quarter.
For more information, please visit www.youtube.com/watch?v=dY7ZQM5eah8 and
www.youtube.com/watch?v=Am-yqoRqF_M&feature=related
There is also an app that runs on the iPhone. By combining the iPhone app and the case together, you have a real-time, single-lead, cardiac lab recording quality ECG device that comes at an extremely low cost. It turns the iPhone 4 into a clinical quality ECG rhythm diagnostic device. It has the same specifications as any cardiac event recorder that would be prescribed by an EP or cardiologist to a patient with an unknown arrhythmia. It displays the ECG and processes it in real time. It also does beat identification, so it can tell normal beats from ventricular beats, PVCs. It allows the detection of atrial fibrillation after a certain amount of time. In addition to that, it stores all the ECGs on the iPhone itself, as well as transmits it in real time securely to our servers, where you can review it through a web browser — either all the stored files, or you can view it in real time through a web browser.
In addition to the ECG data, it transmits the bpms per patient in real time, the 3X accelerometer data, and the gyroscope data. So you know if the patient is lying down, if they’re standing up, or if they’re sitting.
I’ve been contacted by people at academic medical centers all over the world. The 
cardiology community is literally all awhirl in the US. People see this as a tool they can use to very quickly assess a patient without pulling in an ECG machine and hooking it up. You put it on the patient’s chest and have an instant rhythm diagnosis (for example, if a patient is having runs of ventricular tachycardia or is in atrial fibrillation) literally within 30 seconds. It’s like an ECG stethoscope, which could be very useful for anybody from EPs to family medicine doctors or nurses, to EMTs.
It can also be used by patients to record their rhythm. You can hold it in your hands, and that gives you a standard lead 1 (left arm minus right arm), or you can put it on your chest. So 
you can either get a frontal precordial lead (V1, V2) or you can hold it in your hands and get a standard lead 1. It depends on the patient, but in many people you get very clear P waves if they’re there. Obviously we can put up calipers and do measurements. You can freeze it and measure things like P-R interval or R-R. This is not a device to diagnose an acute MI — it’s not a 12-lead ECG. It’s not a device to look for diagnostic long QT as a result of drugs or some kind of congenital problem. Those require 12-lead ECG. This is not that. This is a very fast, very simple, wireless Internet-connected, inexpensive rhythm assessment device.
What made you come up with the idea to create this product? Why is there a need for such a product?
Well, I’ve been in the area of cardiovascular assessment technology for a long time. Most companies in the ECG business have either licensed my technology or bought it from me. In 2001, GE Healthcare purchased my company, Data Critical. We owned PaceArt, and we owned several different types of technologies, and in 2004, I essentially retired as Chief 
Scientist of GE Cardiology. I was very involved with Guidant, Medtronic, and others. So after I left Duke University, where I was in medical school and biomedical engineering grad school, I spent the 1980s working in research labs with a number of prominent physicians. For example, I worked with Dr. Galen Wagner and Dr. Eric Prystowsky, who are very good friends of mine. So I’ve worked with many of the senior EPs around the country. I’ve been watching this, and I’ve been building and developing technology that’s always more compact, more expensive, and more sophisticated. Clearly we all understand that our healthcare system is under some stress, and cost is a major issue, whether it’s for atrial fibrillation, pulmonary vein ablation, or cardiac resynchronization therapy. All of these are very big public policy issues, not just medical issues. Unfortunate, but true. And so, I sat here and said, how can I improve healthcare, whether it’s in Africa or in a rural village in India, and bring the kind of knowledge I have and the technology I have to be just as valuable in a rural village in Africa as it is at Duke Medical Center?
What I capitalized on was the incredible power of the iPhone. I would say every EP in the 
country has a smartphone today, and relies on it. In the third world, it’s the only technology infrastructure that exists — there’s no running water, there’s no wired telephones, there’s no electricity, there’s only cell phones. That’s it. There are millions of cell phones in China in areas where they don’t even have running water. And it’s the same way in India and in Southeast Asia. So I will tell you that by capitalizing on the power of the smartphone and bringing some relatively clever technology, we are able to bring acute rhythm diagnosis to places where it hasn’t existed before, at a price people can afford.
Then once people are treated, whether it’s with dronedarone, ablation, weight control, or anticoagulation, we’re going to be able to allow those patients to follow themselves at a much reduced cost for the rest of their lives, which we now know is probably mandatory.
How soon before we see one commercially available, and what cost would it be like?
First, the final price of the device hasn’t yet been determined, but I can tell you that it will be a fraction of anything available today, period, because it relies on the smartphone that people already have, so most of the cost is in the iPhone or in the Android phone. So what we deliver will be at a very low cost. Second, the device hasn’t been cleared yet, so we are in the middle of doing the studies and preparing for the FDA to settle. I’ve done many, many FDA studies, and while you can never tell, I think it’s pretty clear to everyone the clinical value of this technology, and as I told you, there’s no compromise on the quality of the ECG. It’s as good as any cardiac event recorder. I’d even go as far as to say it’s better, because we have much more power and can do much more processing than conventional event recorders. So there’s that capability, and then as I said, because it’s on the iPhone, we can wirelessly transmit that ECG to our server, so an EP in a university medical center literally on the other side of the world can be consulting with a primary caregiver somewhere very isolated. This is another very powerful concept, and how that’s delivered is to be determined, but it will be available. The hardware will be available in the second quarter of this year. We hope to have this on the market in the United States by the middle of the year, but that will be dependant on our status with the FDA.
Are there plans to make it compatible with other smartphones?
There is an Android version already working, so it will be for the iPhone first and then Android. I can tell you that when I went to the Consumer Electronics Show, other smartphone manufacturers were very interested in talking with us, as you might imagine. So we’ll be evaluating supporting this technology to other platforms as we believe it’s a smart business move.
What kind of feedback have you received, including at the Consumer Electronics Show?
Well, as I was getting prepared to go to the Consumer Electronics Show, there were 5 companies that told me they were not going to have representatives at the show. So my 11-year-old son, who is a YouTube expert, taught me how to use a webcam to make a video and upload it. So I did that, and I posted the link to that video on my LinkedIn page, which goes to my Twitter account. Well, I only had about 100 Twitter followers, so I didn’t expect anything. However, that evening I had 4,000–5,000 views of that video, and I was shocked! The next morning, I had 25,000 views. Then the website engadget.com picked it up, so I’m up to 170,000 views. I’ve been on CBS, ABC, CNN, and Fox. There have been hundreds of stories all over the world, translated. Cardiologists in the US and from all over the world have been writing me. Doctors have been contacting me to ask when they can have the device.
Of course, I’ve also had about half a dozen people telling me it’s absolutely impossible and a complete fake. But my son said, “Dad, you haven’t really made it until you have your YouTube haters. Now you know you’ve made it!” There’s a blog in Czechoslovakia that one of my partners sent me, and it’s in Czechoslovakian, and these people all talk about how it’s completely fake. They even add that we never landed on the moon, it was done on a stage. So it’s pretty humorous. I guess I should be flattered that they believe what we’ve done is so cool.
We’ve had phenomenal response. We’ve had many cardiologist bloggers cover this. The Heart Rhythm Society (HRS) has tweeted about this device, and they’re going to be doing our clinical trials, including the initial ones here at the University of Oklahoma Medical Center. So it has been very exciting. We’ve got to try to bring our 21st century technology at a reduced cost people can afford without breaking the system, and that was our goal all along.
Tell us about the biofeedback capability.
The device bears a second application that will be available since it doesn’t require FDA approval. The app basically uses clinical-quality ECG and performs beat-to-beat heart rate — in essence, it takes heart rate variability, graphs it on the iPhone screen, and then allows you to listen to relaxation audios through your headphones while you’re getting your immediate heart rate feedback. So I can send you a picture of me putting my heart rate into what we could call a parasympathetic band. Through deep breathing and relaxation, you’re able to allow your parasympathetic nervous system to dominate over your sympathetic nervous system. These are all very well understood techniques. You’re able to lower your heart rate and make the heart rate variability a very narrow band as the vagus dominates over the sympathetic nervous system. It’s useful to all kinds of people who have potentially sympathetic dysarrhythmias. There are such devices available today over the counter, and this will be available as soon as our device ships in the second quarter.
For more information, please visit www.youtube.com/watch?v=dY7ZQM5eah8 and
www.youtube.com/watch?v=Am-yqoRqF_M&feature=related 
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