AliveCor's iPhone ECG is not an FDA-approved medical device

Dr. David Albert is one of wireless medicine's old guards. As he puts it: "I did what AirStrip is doing 15 years ago with the first Nokia smartphone. I also have a patent that is probably the seminal patent for handheld ECGs, but GE owns that now since they acquired my company. I'm an old pro in this business."

If you hadn't heard about Albert's mobile health pedigree from 15 years ago, you might know him as the inventor of iPhone ECG, which was the headline grabbing story from the CES event in Las Vegas last week -- not just for health-related news, but one of the most popular stories coming out of the year's biggest technology show overall, too. Albert's device was featured in reports from NBC, CBS, Fox, CNN and more.

In an expansive interview with MobiHealthNews, Albert explained the many uses cases for his single lead ECG device; why he thinks there are too many complaints about FDA regulation of mHealth; next steps for the iPhone ECG device; and more.

Albert also let it slip that his ECG case for the iPhone is already working with at least one other smartphone.

The Android version is already done: "We have it working on the least expensive Huawei Android device," Albert said. "We will make a credit card sized device that will allow this to work with any tablet, any smartphone, any laptop in the future."

The many use cases of iPhone ECG

Albert rattled off a laundry list of use cases for the iPhone ECG, some of which his team conceptualized after reading through emails from various health care providers and consumers who explained how they believed the device could meet their needs.

"I thought that this was a device for general practioners to use as an 'ECG stethoscope' with which they could immediately assess a cardiac rhythm," Albert said. "Today you can listen with a stethoscope or take a pulse, but you really have no idea what rhythm somebody is in. I also thought it would be of interest to patients: Patients today are given single channel cardiac event recorders and they have been given those for the past 25 years."

Albert is clear on what iPhone ECG is not: "This is not a device for diagnosing acute MI (myocardial infarction)," he said. "It is not a device for detecting long QT. Both of those require a 12 lead electrocardiogram. This is a single lead rhythm script device. It is clinical quality -- ours is not a sub-quality, sub-standard ECG -- it's just a single lead."

Albert said that hundreds of people, mostly emergency medical technicians (EMTs), have suggested that the iPhone ECG could become an integral tool for emergency responders. While EMTs today carry devices like the LifePak 15, Albert said EMTs told him those devices are no good when a patient is unconscious and trapped inside a vehicle, stuck in a hole, or at the bottom of a cliff face. A smaller device like the iPhone ECG might be easier to use in tight spots, Albert argued.

"These [EMTs] told me that this is a tool that not only let's them know the patient's rhythm status, but it also gives them the ability to transmit that information back to the physician in the emergency room."

A particular group of empowered patients also emailed about the iPhone ECG, according to Albert. "I had about 30 retired physicians who now have atrial fibrillation write me and say that they know they go in and out of rhythm but they are too embarrassed to go into the emergency room unless they could be sure," Albert said. "There are billions of people around the world who are cardiac patients who do not want to complain about the symptoms to their doctors. They want real clinical data, because otherwise when they go in the doctors will think they are crazy. You have no idea how often that happens. There is a very real use case here that this product, which is so inexpensive at under $100, that these patients could use it to sample their rhythm and provide it to an eCardio, Lifewatch, CardioNet in between those mobile cardiac telemetry sessions" their payers are sometimes willing to provide them once or twice a year, Albert said.

Albert stressed that his device does not replace MCT offerings like those from CardioNet and Lifewatch, but he argues that his device has some additional features MCT offerings typically don't: "This is a cardiac event recorder that just happens to be intelligent, wireless and GPS-enabled. Understand, we send the GPS data with the ECG along with accelerometer and gyroscope readings. That means we know when someone is laying down. This makes for a tremendous amount of data that a traditional event recorder doesn't have."

The final use case that Albert mentioned during the interview was with in pharma drug studies. The FDA is interested in seeing more collection data during Phase IV followup with drugs for some atrial defibrillation patients. "Pharma companies working in this field are going to be very interested in deploying this kind of device to hundreds of thousands of patients," Albert said. "It's really disruptively inexpensive."

Mobile health amateurs are creating the FDA noise

"The people who complain about the FDA just don't understand how the FDA works," Albert said. "I'm a free enterprise guy and I believe lawyers can be and should be as free enterprise as anyone else. The fact is that this shouldn't be that complex. I expect zero issues when it comes to FDA clearance of our device," he said. "Mobile healthcare is a strange place and we have a lot of newbies. The newbies are confused by the arcane rules from people like the FDA, other weird things and healthcare acronyms. For old people like us, it's just standard operating procedure."

The FDA has been reviewing mobile health devices for a good many years: "In 1997 I got a 510(k) on a product called Rhythm Stat XL which displayed ECGs on a Scion PDA," Albert said. "Is the cell phone now regulated? Yes, the cell phone is a component of our medical device. There are a lot of medical devices that have cellular connections in them and there have been for a long time. Just look at defribillator monitors with all kinds of cellular, WiFi or Bluetooth embedded."

Albert raised an interesting point on regulating the iPhone versus regulating the many Android devices: "When AirStrip got its most recent clearances for Android there were three specific Android devices mentioned," Albert noted. "A device will never be approved for 'Android,' it will be much more specific. Those three Android devices were verified, validated, corrobated and tested. By the way the Verizon version of the iPhone is different from the AT&T version of the iPhones. They are separate devices. So, we will have to test those separately with iPhone ECG and we will."

Albert concludes that the iPhone 4, the sleeve or device's case, the app and even the company's server are all components of the medical device. Albert mentioned future plans to generate PDFs of the ECG data via the iPhone ECG app and send that PDF directly to a printer. "That printer is now part of the device," he said.

"The AirStrip team clearly followed the rules and have done it right. So Mazel Tov to them!" Albert said. "My point is that there is a process already in place here. The iPhone is definitely a component of that medical device along with the other components. When that data makes it to the physician, the FDA wants to be sure it has not been distorted."

What's next for AliveCor's iPhone ECG?

Albert's team is already piloting the iPhone ECG in intensive care units under institutional review boards, he said. Albert has already begun his discussion with the FDA to get the device cleared as a medical device in the US, and his manufacturer expects to have a CE Mark that makes iPhone ECG available sometime in the second quarter of this year in other countries, including the European Union.

The US market will likely encounter iPhone ECG in a different form factor first: "We are going to have a continuous monitor, a chest strap that is better and cheaper and works with any smartphone," Albert said. "People can wear the monitor while they are exercising or while in cardiac rehab. It will open up a whole bunch of new applications but with exactly the same hardware."

Albert hopes to have the product cleared with 510(k) in the next few months. His team is compiling the clinical data and he expects some of it to be published soon. He expects to investigate the new applications that the tidal wave of publicity brought to his attention, including the EMT applications also.

Albert is also bullish that incumbent medical device makers and heart monitor services companies will be lining up to add iPhone ECG to their current offerings as a complementary one.

"I really didn't think this thing would go viral," Albert said of his YouTube video demo, which has more than 160,000 views as of this writing. "We never thought anybody would see this but the companies we were talking to. It was an accident -- maybe a propitious accident -- but an accident nonetheless."

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