The FDA has granted a 510(K) Class II clearance to San Francisco-based AliveCor's iPhone-enabled heart monitor, which has been commonly known as the "iPhoneECG" since it first made an appearance at CES two years ago. The company announced the clearance as the mHealth Summit kicks off this week in the Washington DC area. AliveCor will begin pre-selling the $199 clinical-quality, ECG monitor, which has the form factor of an iPhone case that fits iPhone 4 and 4S devices, directly from its website starting today, December 3rd.

AliveCor CEO Judy Wade told MobiHealthNews that within a few months the heart monitor will be made available in three different ways. Starting this week physicians can buy them from AliveCor's website for $199, and the site will require them to provide the medical identification numbers to prove that they are indeed a physician. Wade said that pricepoint is less expensive than most electronic stethoscopes. Starting early next year the company plans to encourage physicians to make the device available to their heart patients via prescription. While the specific details, including pricepoint for prescribed devices, has not yet been fully worked out, Wade told MobiHealthNews the price of the device could hover somewhere around $99 for patients whose doctor prescribes one. Finally, assuming the company secures its next 510(k) clearance, Wade expects the over-the-counter version of the heart monitor to become available sometime during the second quarter of 2013.

Wade said there are a couple of initial use cases for the device: Patients who feel like they have a heart arrhythmia problem, but are asymptomatic and it doesn't show up when they visit their doctor's office. This device can be at the ready if the patient has it with them, and it can be used to record the heart rhthym strip the next time the patient feels something. Another use case is for someone who has already been diagnosed with atrial fibrillation and has been treat with ablation and/or medications. Wade said a physician could prescribe the device for at-home use so that they could monitor the patient remotely and determine whether the therapy was effective or is working. The device is also a preventive medicine tool since it detects arrhythmias, which can be a problem in and of themselves sometimes but can also be associated with something else -- like an imminent heart attack.

Wade said that longterm the company sees a lot of power in recording and analyzing peoples' EKGs. AliveCor refers to this as the "deep data" opportunity, as opposed to the more commonly used "big data".

"Our vision is for everyone to have their health at their fingertips. Hopefully, before long, we will have millions of [ECG] recordings that we will be able to contextualize around simple things like your age and height. In the future the platform won't only be interpretive it could be predictive as well. That's why we have been very active in participating in clinical research and trials with the device because hopefully a lot of interesting research will come out of it."

This week's FDA clearance enables AliveCor’s Heart Monitor to be sold and marketed to "licensed medical professionals to record, display, store, transfer, and evaluate single-channel electrocardiogram (ECG) rhythms," according to the company. "The rhythm strips can be of any duration, and are stored on the iPhone and securely in the cloud for later analysis, sharing and printing through AliveCor’s secure website. The ECG data is sent wirelessly from the Heart Monitor via AliveCor’s low-power, proprietary communication protocol, and requires no pairing between the iPhone and the device."

Here's how the device works: "The device incorporates electrodes into a case that snaps onto the back of an iPhone 4 or 4S. The Heart Monitor is used by launching the corresponding AliveECG app on the iPhone, holding the device in a relaxed state, and pressing fingers from each hand to each of the two appropriate electrodes on the device. The device can also be used to obtain an ECG by placing it on the chest."

AliveCor expects to launch its Heart Monitor in the form of a "universal module" (that is similar but different to the credit card-sized prototype the company has demo'd in the past) that will work with iOS and Android devices by Q3 next year. Following that the company plans to launch a "pad" version of the heart monitor that is big enough to place your entire hand on. This form factor could be placed in health kiosks or doctor's offices. Each of the form factors would likely require additional clearances from the FDA.

The company also secured its CE Mark and a European launch for the initial form factor is expected early next year.