New medical device, ECG on IPhone

Would you as a heart patient consider this device? One of the issues to understand is how a 12 lead ECG works vs. a single lead ECG. To understand this, pick up a piece of paper, look at it from every conceivable angle…front, back, top, bottom, side views. This gives a one directional view of the heart, so it really depends on where the issue lies if you are trying to pick up ischemia…lack of blood flow to heart muscle. An ECG has limited ability to diagnose heart attacks, that is why we use serial blood tests to measure enzyme troponin release to diagnose. Now don’t get me wrong, in many heart attacks there are EKG changes, but they don’t always show in a single lead ECG.

I think this tool is beneficial, especially for capturing arrhythmias or irregular heart rhythms. The second issue is if you use this device, who will read the data and what action will they take? Do you download and send to your cardiologist, your primary care physician, or the ER. Then who is responsible, and from their perspective who gets paid for reviewing. Many physicians are overworked and to add interpreting medical device data to their day won’t go over well in today’s environment. I perceive the future will have more devices like this, but the medical community needs to change current practices, and change is slow.

A new device and app is taking the mhealth capabilities of the iPhone to a whole new level.

San Francisco-based AliveCor announced Monday that it has received clearance from the U.S. Food and Drug Administration to market its heart monitor. Now, U.S. users of the iPhone 4 and iPhone 4S can shell out $199 (taxes and shipping are extra) to preorder the device, which begins shipping in January. Oh, and in case anyone was wondering, the iPhone does not come included, the company’s website notes handily. (Looks the like final device ended up costing more than the $100 that founder and physician David Albert at one time envisioned.)

So how does it work? The small wireless device comprising two electrodes can snap on to the back of an iPhone and then the souped-up iPhone can be placed next to the heart, against the skin to deliver clinical quality electrocardiograms. It functions like any iPhone cover intended to protect the smartphone.

Before the FDA clearance, prominent cardiologist Eric Topol used the device on an air plane to determine that a fellow traveler was having a heart attack, ordering the plane to land.

While interest in mhealth is exploding, this device appears to be mhealth on steroids, given that it is actually a physical device aiming to give medical data. The device has been eagerly anticipated by mhealth watchers and it will be interesting to see how well the product is adopted.

Perhaps this is the beginning of what Silicon Valley VC and provocateur Vinod Khosla proclaimed when he said that machines will one day replace 80 percent of middling doctors. No surprises that Khosla Venture, his VC firm, is an investor in AliveCor.

In June, the company raised $10.5 million in a series B round from Khosla Ventures as well as existing series A investors like Burrill & Company, Qualcomm Ventures and Oklahoma Life Sciences fund.

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