AliveCor's iPhoneECG device, which was the talk of CES in 2011, is close to securing a CE Mark, paving the way for the device to roll out commercially in Europe. At least one speaker at the HIMSS event last week and at least one report coming out of the Burrill Digital Health Meeting earlier this month, claimed that the iPhone ECG's CE Mark was already secured. AliveCor founder Dr. David Albert told MobiHealthNews this week that the company is in the final steps of the process, but that it is not yet secured.

The company is also pursuing FDA clearances for its iPhone ECG case and iCard device, which works with both iOS and Android devices. FDA clearance is expected soon, too. AliveCor has stated in the past that it expects its device to retail for $99 and that it will find a user base among heart patients, general practitioners, emergency room technicians and more.

“I thought that this was a device for general practitioners to use as an ‘ECG stethoscope’ with which they could immediately assess a cardiac rhythm,” AliveCor founder Dr. David Albert told MobiHealthNews in an interview last year. “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 said patients could use his device to sample their rhythm and provide it to an eCardio, Lifewatch, CardioNet in between their mobile cardiac telemetry sessions, which payers generally only reimburse for once or twice a year, he said.

Albert had made clear in the past that the iPhone ECG is not a device for diagnosing acute MI (myocardial infarction) or detecting long QT, since both of those require a 12 lead electrocardiogram. AliveCor's devices are single lead rhythm script devices. Albert says that they are "clinical quality" though.

The AliveCor devices also send GPS data with the ECG along with accelerometer and gyroscope readings from the user's device. That way those reviewing the information know whether the user was laying down. AliveCor expects to offer a free iPhone app for patients, with a paid version for physicians.

Last year AliveCor announced $3 million in its first round of funding, with participation from Burrill & Company, Qualcomm Ventures and the Oklahoma Life Sciences Fund. At the time the company said it planned to use the investment to expand its team, gain regulatory approval and market the device worldwide. In August 2011, at the time of the funding announcement, the company stated that it expected to commercially launch its iPhone ECG case and possibly its wireless iCard late in 2011.

The iPhone ECG first got notice in late December 2010 when Albert uploaded a video demo of the device to YouTube. The video went viral and made the device one of the most talked about at the Consumer Electronics Show in January. The video has since received more than 350,000 views.

Interestingly, while the iPhone ECG strongly associated with the iPhone, Dr. Albert’s AliveCor Australian co-founders Bruce Satchwell and Kim Barnett began working on the ECG device in 2005, which is well before the iPhone launched. The Oklahoma City Chamber of Commerce originally helped bring the business to Oklahoma City in 2008, according to the company.

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