Eric Topol, prominent San Diego cardiologist and chief academic officer at Scripps Health has already used AliveCor twice on commercial airlines to successfully diagnose passengers with irregular heart rhythms.  He believes that the device should be carried on commercial airplanes.  The AliveCor Heart Monitor, founded in 2010 by David Albert, Kim Barnett and Bruce Satchwell is the only FDA cleared mobile ECG recorder that supports both iPhone and Android mobile devices. AliveCor is a privately-held company with headquarters in San Francisco and its investors include top healthcare technology investors Khosla Ventures and Qualcomm Ventures.

I was lucky enough to get to try out the device for myself and have an interview with Iman Abuzeid, Senior Product Manager of AliveCor.  I received the device in the mail and found the setup very easy, after a few minutes I was already viewing my own ECG, something I had never done outside of the hospital.  Next, after reviewing the help section I was able to take my own lead II ECG without previously even knowing what a lead on an ECG was.  After the ECG was completed, I had the ability to email the ECG, print the ECG or get an ECG Analysis.  AliveCor provides three levels of ECG analysis, clinical analysis and report by a U.S. Board Certified Cardiologist ($12), preliminary finding by a U.S. based Cardiac Technician with a thirty-minute turnaround time ($5) and preliminary finding by a U.S. based Cardiac Technician with a twenty-four hour turnaround time ($2).  The app is very user-friendly and contains an education section which teaches users about cardiac anatomy, common heart arrhythmias and ECG technology.

Below is my ECG, which was taken with an AliveCor Heart Monitor

Interview with Senior Product Manager, Iman Abuzeid, MD 

HealthIT & mHealth: Can AliveCor detect heart attacks?

Iman Abuzeid: The AliveCor Heart monitor that is currently on the market cannot detect heart attacks, because it is a single lead device, which means it is only taking one view of your heart.  The device would need at least six leads to detect a heart attack.

HealthIT & mHealth: How many leads can AliveCor currently detect?

Abuzeid: AliveCor can currently detect different leads depending on where you place the electrodes. Lead I uses your fingers, lead II uses one hand and a knee and the chest lead uses your chest.  All leads have the same accuracy.

HealthIT & mHealth: What is AliveCor best used for right now?

Abuzeid: It is best used for heart arrhythmias, such as atrial fibrillation or supraventricular tachycardia; an ECG can detect abnormal rhythms from just a single lead.  Atrial fibrillation is the most common heart arrhythmia in the population

HealthIT & mHealth: How many algorithms do you have?

Abuzeid: We currently have three algorithms, atrial fibrillation, interference and normal.  All three algorithms have FDA clearances and atrial fibrillation is currently in our product that is on the market.  The atrial fibrillation algorithm detects if atrial fibrillation is present in the ECG.  If detected an alert will appear and the user would need to confirm the diagnosis with their provider or the ECG analysis service.  The interference algorithm tells you if your recording is noisy and the app will suggest that you record the ECG again.  The normal algorithm will tell you if your heart rhythm in that ECG is normal.  The Normal and interference algorithms will be included in the app in the next coming weeks and will be available to patients and providers.

HealthIT & mHealth: How accurate is your atrial fibrillation algorithm?

Abuzeid: It is 98% specific and 97% sensitive

HealthIT & mHealth: How does the technology work?  Is it similar to an LED heart rate monitor?

Abuzeid: The technology is actually quite different from the LED heart rate monitors.  When you place your fingers on the electrodes on the heart rate monitor it creates high frequency sounds, which are picked up by the microphone of the mobile device. The app then, converts the sound into a digital signal, which is the waveform that is seen in the AliveCor app.  Unlike AliveCor, LED heart rate monitors are not regulated by the FDA, so their quality can vary.  Light technology, especially LED technology can be less accurate if the user has cold fingers or poor circulation.

HealthIT & mHealth: What is the best way to get an accurate ECG reading with AliveCor?

Abuzeid: Be relaxed, place your hands on a flat surface and then rest the heart monitor on your fingers.  It does take a little bit of getting used to in the beginning, however the more you use it, the more you get accustomed to it.

HealthIT & mHealth: What FDA clearances and patents do you currently have?

Abuzeid: We have FDA clearance on the hardware itself and our algorithms, each algorithm needs to be FDA cleared.  We are in the class II medical device category, and our FDA clearances are 510(K)s.  We also have multiple patents on the technology of monitoring cardiac performance with mobile devices.

HealthIT & mHealth: What EHR’s do you integrate with?

Abuzeid: We currently integrate with Practice Fusion via HL7 to send results into the EHR.  If you are a provider that utilizes Practice Fusion with an integration with AliveCor, as soon as you record an ECG, an alert will appear and ask if you would like to send the reading to the EHR as a PDF.

HealthIT & mHealth: What are your reimbursement codes?

Abuzeid: Our customers report using the CPT 93040 code for 1-3 lead ECG tracing.  This code can be used if the device is used in a provider’s office or at the bedside.

HealthIT & mHealth: Who are you partnered with?

Abuzeid: For our US distribution efforts, we are partnered with GreatCall, a company that creates mobile phones for the elderly, Omron Healthcare a leading manufacturer of home blood pressure monitors for retail pharmacies, and our device is available through Amazon

HealthIT & mHealth: What hospitals are you doing studies with?

Abuzeid: Cleveland Clinic, UCSF, USC, Columbia University, Massachusetts General Hospital, Oklahoma University, the University of Sydney, and many more

HealthIT & mHealth: Where can customers purchase AliveCor?

Abuzeid: In the US, they can purchase through Amazon or through AliveCor’s website