Wireless, ultrasonic personal health monitoring system: Instantaneous and personal health information at your fingertips—that is the oft-imagined innovation that could change medicine. Physician-inventor David Albert, chief medical officer of AliveCor, headquartered in San Francisco, first envisioned a portable, easy way to measure personal heart health when Palm Pilots debuted in the late 1990s. Smartphone processors, however, were not powerful enough until the latest generation of devices such as the Droid and the iPhone.

After several clinical trials, the U.S. Food and Drug Administration approved Patent no. 8,301,232 for use last November. The patent describes an electrocardiogram (ECG) device that snaps in place around a smartphone, currently the iPhone 4 or 4S, like a protective cover. The case is embedded with sensors and electronics that measure the electrical activity of the heart. Users can record their heart rate by placing their fingers on the sensors. An ultrasonic signal relays data from the monitor to the smartphone and the AliveECG app. A distant physician can examine the pattern over a secure wireless connection. The readout is not as complete as a typical 12-lead ECG, but the smartphone version provides an accurate proxy in tests.

“The ECG is a valuable and extremely well understood way of assessing the heart and allowing us to diagnose problems,” Albert says. “We wanted to put that power into the pocket of any physician, nurse, EMT—and ultimately give power to the patient as well.”

The display still requires a trained eye to decipher, but the company is rolling out improvements. For example, one pending patent details a software enhancement that automatically detects atrial fibrillation—a common arrhythmia responsible for one third of all strokes.

This article was originally published with the title Patent Watch.

3 Comments

1. 1. SAReadersince67 07:06 PM 2/24/13

   Nothing can replace the skilled physician or nurse for taking a blood pressure measure, or listening to a heart. A useful and reliable blood pressure, pulse, or heart rhythm check requires interpretation in the context of the patient presenting to the physician or nurse. While there may be a role for biomedicine, it should not be a substitute, but a aid only to hands-on practitioner monitoring of cardiopulmonary function. Blood pressure gadgets and the like are subject to error and misinterpretation even when used by physicians, and such devices operated by patients or unskilled persons can give results subject to misinterpretation. There are many ways to reduce the costs of Health (Sick) Care, but where the subtle characteristics of cardiac and some other functions are involved better to have the services of a skilled practitioner. Looking for savings by reducing this essential aspect of Health Care is to raise the probability of false economies, as short run savings are likely to lead to longer term costs, where disease processes are concerned. Of course, medical technology operated by skilled persons can be both effective and efficient. But let us not be distracted by the technology when it is well established that the application of skills and insights of your Doctor or nurse standing beside you is good medicine.

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2. 2. SAReadersince67 in reply to SAReadersince67 08:04 PM 2/24/13

   My previous comment should have read:
   ... While there may be a role for telemedicine, it should not be a substitute, but an aid only to hands-on practitioner monitoring of cardiopulmonary function.
   
   Spell checker does not like the word "telemedicine" but I have seen the term for many years. I first noticed the word employed in a program to develop Health Services for rural Newfoundland about 3 decades ago.. But I don't think it was a new "coinage" then..."

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3. 3. arkadyg 11:35 AM 2/25/13

   There is an in-accurate statement in the beginning of the second paragraph: “After several clinical trials, the U.S. Food and Drug Administration approved Patent no. 8,301,232 for use last November”.
   
   There are two in-accuracies in this statement:
   1)The FDA does not approve the patents, but rather approves or clears the devices. The design of the device may be, but does not have to be, based on a patent.
   2) The mentioned device is Class II per FDA classification, and therefore was cleared rather than approved by the FDA (FDA clearance letter K122356, November 19, 2012).
   
   The suggested correction to the statement is by clarifying that the design of the device is based on a 8,301,232 patent, and that it was cleared by the FDA last November:
   
   “After several clinical trials, the U.S. Food and Drug Administration CLEARED THE DEVICE DESIGNED BASED ON Patent no. 8,301,232 for use last November”

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