Quick -- you're watching House, M.D. with a friend and he suddenly complains of lightheadedness and heart palpitations, then passes out on your couch. Is it a common atrial fibrillation, or is it a third-degree atrioventricular block needing emergency atropine and an electrical pacer?
Soon, assuming you're either a medical professional skilled in electrocardiography or you play one on TV, you'll be able to make the differential diagnosis using just an iPhone 4 and the AliveCor iPhonECG.
The iPhonECG is a sleek, low power case that turns the iPhone 4 into a wireless, clinical quality cardiac event recorder. It was invented by Dr. David Albert, a self-described "serial entrepreneur and inventor who happens to be an engineer and a physician with 30 years in cardiology." Dr. Albert sold his last company, Data Critical, to GE Medical Systems, where he then worked as Chief Scientist of GE Cardiology.
Albert's goal was to make heart monitoring affordable both for chronic heart patients and third world caregivers. Instead of devices costing tens of thousands, he wanted to make a device anyone could afford.
"I've made a lot of very expensive equipment," says Albert. "I don't care where you stand politically, the bottom line is the United States has a fundamental healthcare problem called 'How're we gonna pay for it?' And I've been part of the problem.
"So what I decided is that I could make a contribution by taking the things I knew, and capitalize on the smartphone wave, to make a device that gives a guy in a rural village in India capability that they've not had before."
When asked if Dr. House could use the iPhonECG to solve a case, Albert says his kids love House and asked him the same thing. But the House scenario is not the point. "We're making this at a price not just appropriate in Dr. House's hands at a university medical center, but just as appropriate in a family medicine office or a nurse practitioner's hands in rural Mexico."
In a YouTube video that went viral over the New Year holiday, Albert demonstrates how easy it is to use.
Dr. Albert, who works in Oklahoma City, says it took a global effort to make an ECG/EKG the world can afford, with manufacturing in China, software development in the gold coast of Australia and business partners in Seattle, adding up to a manufacturing cost per device of less than US$15, allowing a retail price under $100.
Typically, patients with chronic heart conditions can only get Medicare coverage for a couple heart checkups a year. Albert aims not just for an affordable device, but affordable proactive monitoring.
"What we're offering is much higher sampling volume at no additional cost for the rest of their life," Albert says. "So every day, for literally 30 seconds, a person holds this in their hand or puts it on their chest, and somebody who knows, or the device itself, can tell if they have atrial fib. Plus, we can upload it immediately and a CCU nurse can say, 'Mr. Jones is back in atrial fib' or 'he's having heart block back again and his pacemaker's not capturing, so that's why he feels funny.' It can do that at a cost anybody can afford. That's disruptive."
Medical devices in the United States need an FDA approval known as a 510(k). The iPhonECG apps showing an ECG chart, analyzing it and uploading it, each require a 510(k). AliveCor is in clinical studies in cardiac care units, making sure what patients' bedside ECG monitors show is exactly what the iPhonECG shows. AliveCor aims to file for the FDA approvals by March, applying both as a product used by caregivers (doctors, nurses, EMTs) and as a product used by patients. These healthcare apps will become available as AliveCor receives the clearances.
If AliveCor gets to market and gets FDA approvals, it could change the cost of heart screening, with the retail price of the iPhonECG about the same as Medicare would reimburse for just five tests. Aetna's Cardiac Event Monitors policy bulletin offers a background on cardiac screening hardware, with discussion about what would likely be covered by Medicare. The 2011 Medicare handbook, page 35, says Medicare will pay for a one-time screening EKG if ordered by your doctor. American College of Emergency Physicians says doctors can get reimbursed for ECG interpretations. This could potentially cover the "Lead I" rhythm strips shown in the iPhonECG video.
Medical professionals or patients interested in updates about the iPhonECG can register for product updates at AliveCor.
While its professional apps are pending clearance, AliveCor plans to release the iPhonECG case with consumer apps for beat-to-beat heart rate and biofeedback. The case should be about a quarter the size and weight of a Mophie Juice Pack Air, making it convenient to carry, while higher quality than other recorders.
Dr. Albert said he's "overwhelmed" by the sudden attention to a YouTube video he expected only five friends would see. But with 80,000 views so far, and 4,000 views an hour and climbing, he's enthusiastic.
"I've had people say to me, is this going to be 10% as good as a regular EKG machine? I say, no, it's 100% as good. In fact, it's better than many of the cardiac event recorders that are out there. I know -- I've made them. This can be a global device, bringing cardiac event recording to remote places that never had it, at a price even they can afford."