AliveCor competitor gets OTC clearance from FDA

By: Jonah Comstock | Mar 12, 2013        

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ECG Check

Cardiac Designs' FDA-cleared ECG Check, not yet commercially available.

A new ECG device for the iPhone 4s called ECG Check received over-the-counter clearance from the FDA last month. The device, which would be the first product from Park City, Utah-based Cardiac Designs, appears very similar to the AliveCor Heart Monitor, which is currently only cleared for prescription use. The device was submitted to the FDA July 23, 2012, one week before AliveCor’s July 30 submission.

Cardiac Designs is an apparent newcomer whose website has been registered since 2011 to N88 Consulting, a company run by Karim Marrouche. According to the FDA documents, Marrouche is the Managing Director of Cardiac Designs. The company’s website describes the ECG Check as coming soon, and says that it will be available for the iPhone 5 as well as the 4S, although the FDA filing mentions only the 4S. (AliveCor is presently only cleared for the iPhone 4 and 4S.) Marrouche was unable to field an interview before deadline.

It’s unclear how close the product is to actual market release. To secure 510(K) clearance, a company doesn’t necessarily need a fully developed product or any clinical data.

The filing describes the device as a “1-lead ECG Event Monitor specifically designed to operate with an iPhone 4S handset.” The device will record a preset amount of ECG activity, typically 30 seconds, and analyze the reading, returning a “stoplight” result: red, yellow, or green. The device automatically transmits results via Bluetooth to the phone, and from there can send it to the company or a care provider. The filing doesn’t mention HIPAA, but does give a nod to data security.

“The data can then be stored locally and/or transmitted to the ECG Check web center for analysis and assessment by qualified professionals,” the filing reads. “The ECG Check web center provides privacy and protection for user medical information and the ability to interact with Cardiac Designs, LLC technicians and engineers, as well as with their own caregivers.”

But although the device is cleared for over-the-counter use, the filing places significant restrictions on the functionality of the over-the-counter version.

“With a physician prescription, the user will be provided access to be able to trend their results and generate reports to provide to their physician or other caregivers,” the filing says. “…Users without a physician prescription will not be able to view the waveform.”

Neither ECG Check nor AliveCor is marketed as a diagnostic device, possibly for reasons related to FDA clearance. ECG Check’s filing documents list it specifically as non-diagnostic, while AliveCor says in the FAQ section of its website that AliveCor’s Heart Monitor does not provide a diagnosis at this time — a trained professional must interpret the results.

AliveCor’s Dr. Dave Albert told MobiHealthNews that he expects the over-the-counter version of AliveCor to be available in mid-2013. Albert said “part and parcel” of the FDA’s over-the-counter category restriction is that the device can only provide metrics, as opposed to raw data. This is a likely explanation for Cardiac Design’s “stoplight” functionality for non-prescribed users. Albert said that how AliveCor intends to deal with that restriction is “an AliveCor secret.”

UPDATE: Marrouche got in touch with MobiHealthNews via email and explained the product’s over-the-counter functionality.

“Upon purchase, the user will have access to immediate feedback of heart rate values and status (green/yellow/red),” he wrote. “Once a consultation can be done with a physician, the ECG and findings can be displayed for the user. This is the way the FDA’s OTC clearance allows currently, but future iterations will enhance functionality for the user’s benefit.”

Marrouche said the company is pursuing partnerships for the diagnostic interpretation of ECG Check’s data. He said the company has not locked in any partners. MobiHealthNews has learned that Marrouche has worked with eCardio in the past through his N88 Consulting company, but he told MobiHealthNews that ECG Check is not currently pursuing a relationship with eCardio.

  • NikhilJGeorge

    Are you sure that AliveCor is not a diagnostic device? A diagnostic device is not one that renders a diagnosis, but rather one that aids in diagnosis. If the AliveCor ECG was not a diagnostic device, doctors would not use it to render an opinion, it would be a toy that would be sold without any FDA clearance.

  • Need and ECG

    Have you seen the HeartCheck PEN, an OTC, ECG device from CardioComm Solurtions? They have fully FDA cleared software independent of the OTC device being cleared.

  • Paul

    Its funny. With all this buzz about these new iphone apps, people fail to realize that the FDA cleared ECG pen from heartcheck is already available without a prescription….AND it comes with the GEMS software (Global ECG Management System) where users can send their ECG recordings to a physician for online analysis. Heartcheck’s parent company, Cardiocom (a publically traded company), has been developing ECG management software for hospitals/clinics for years. Why do people blindly trust anything iphone?

  • Mark

    The thing with these iphone EKG devices is that you can’t even use a regular case with your phone if you get one. Its not very practical if you think about it.

  • http://twitter.com/HugoOC Hugo Campos

    The ECG pen requires its users to install proprietary software on a PC and use a USB cable to connect the pen to a computer whenever an ECG needs to be uploaded. According to a video on their web site, after uploading the data, a report is prepared and made available through the proprietary software installed in the PC. Couldn’t be more impractical if they tried.

  • brad

    Both AliveCor and ECG Check require propertary software be installed on the users smartphone…

  • Cory heard

    Well Alivecor just got beat to market! If I was an investor in Alivecor of be worried! Time to rethink!

  • http://www.facebook.com/tom.fitzsimons3 Tom Fitzsimons

    Can someone please explain to me why I need a prescription or the FDA’s permission to see my own ECG waveform?

  • Faruk

    I tried ECG Check and it sucks! One good thing about ECGCheck. You don’t have to worry about closing the app. Crashes with a 100% strike rate for every time I open the app.

  • Paul smith

    All of these are cheap knock offs of alivcor’s tech. U know what they say “imitation is the most sincere for of flattery.”

  • Errol

    The ECG Check device works well. Both cases (for the iPhone 4s and 5s) have worked well. My wife has a cardiac arrhythmia (several actually). With ECG Check we can control her rate and rhythm with medications at home. We have been able to keep her doctor visits to once or twice a year. The app works well, however the initial registration was frustrating because neither of us had ever used an iPhone until we ordered the ECG Check.