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.