AliveCor receives FDA 510k approval in just 80 days

San Francisco-based AliveCor (@AliveCor) announced at the 4th Annual mHealth Summit that they have received FDA 510K approval for their portable ECG iPhone case, which makes the device available to physicians and patients in the US at a starting price-point of $199. Pre-orders can be placed at the company’s website and expectations are high for the device.

Dr. Dave Albert, AliveCor co-founder and inventor of the device, told me at the mHealth Summit that AliveCor received FDA approval in just 80 days, and he credits this quick turn around to the extensive research his team conducted prior to submitting the device.

Several of the abstracts from that research were made available to conference attendees, including a study conducted in collaboration with Dr. Leslie Saxon of the USC Body Computing Lab. In that study, 54 attendees of Saxon’s annual Body Computing Conference participated in an 8-week study to determine how they each used the device. Results showed participants (43± 11 yrs, 77% male, 15% physicians, 61% business, 13% media/entertainment, 11% engineers) transmitted 36± 53 30-second recordings weekly (range 3-298) for 8 weeks.

In another study provided, the device is compared to standard 12-lead ECGs with gel-based electrodes in 67 patients. Five patients with pacemakers had the iPhone placed directly to their chest as well to record a V3-V4 rhythm strip, and two physician reviewers cross-validated these strips for pacing spikes. In 62 patients, two physicians found the QRS morphology to be the same between device recordings, though the iPhone ECG had more baseline noise than the standard ECG. In the five patients with pacemakers, pacing spike artifacts were clearly identified in all 5 enabling verification of pacing capture.

“We believe that mobile ECGs and other breakthroughs in mobile health can significantly change the way medicine is delivered,” Dr. Albert said in a press release. Albert and his co-founders, Bruce Satchwell and Kim Barnett, were also awarded US Patent No. 8,301,232 for the device and technology.

“Our goal is to make health care cheaper, easier and more readily available without losing quality of care,” said AliveCor President and CEO Judy Wade. “Our aspirations are significant; we’re out to make a real difference.”

I first tried the AliveCor device a few weeks ago when Dr. David Lee Scher, Senior Medical Advisor at Happtique, showed me his demo case while we both attended the M3 Mobility Exchange in San Diego. As an ePatient, I was immediately struck by the device’s simplicity and ease of use. I can’t imagine an easier way to quickly capture my own ECG and transmit it to a physician discretely and securely.

The current version of the device is only available for the iPhone 4 and 4S, but now that they have achieved FDA approval for their first case, I suspect it won’t be long before they release a model for the iPhone 5 as it will likely not need to undergo the same degree of regulatory scrutiny.



Brian Edwards

Senior mHealth Analyst

Follow Me

Click to view 4 Comments

4 Responses to AliveCor receives FDA 510k approval in just 80 days

  1. Marc-Emile Plourde December 18, 2012 at 10:00 pm #

    I think this is cool, but can someone tell me what this could be used for? I mean, to change a patient’s management? Why would a patient want to use a portable one lead ECG?
    I’m just trying to understand…

    • Iltifat Husain, MD December 18, 2012 at 11:19 pm #

      Yea there appears to be a ton of hype with this. So we are actually going to test it out and see what we can find out.

  2. Setty February 13, 2013 at 4:19 pm #

    Please kindly explain whether this EKG can identify the heart location of the start of my Arrhythmias such as from Atrial or Ventricle etc. Very much Appreciated. Thank you.

    • R Bradbury, EMT-Paramedic March 26, 2013 at 3:31 pm #

      Yes, you can get an Rx for this device and it will allow your cardiologist to see the strip remotely via the Internet. You would have to verify that your MD is willing, but I don’t see a reason why they wouldn’t if you have A-Fib, A-Flutter, or some other arrhythmia concern. The device is FDA approved and should clearly allow analysis of atrial versus ventricular ectopy – PVC, PAC, heart blocks, etc. When holding with two hands, it just shows lead I, but with other placement, you could review other leads also. Theoretically, if you hold one electrode in your right hand and the other on your left thigh, you would see lead II or near AVF. With it held over the chest, you could see forms of V leads. Reading the strip can differentiate atrial or ventricular pacemakers, but you’ll need a complex study to find the exact ectopic focus for ablation.

Leave a Reply