AliveCor today announced that its smartphone compatible ECG monitor has been approved by the FDA for over the counter use.

For those not familiar with the AliveCor device, this smartphone peripheral enables users to capture single lead ECG tracings on demand similar to some traditional event recorders. The elegant and simple design of the AliveCor Heart Monitor, however, separates it from most of the currently available devices.

iMedicalApps did an in-depth review of the AliveCor Heart Monitor in which we looked at not only the device itself but the potential real-world applications. Overall, we were quite impressed with the design of the device and its associated app. We did however feel that many applications being advertised for the device, such as routine atrial fibrillation screening, were of questionable validity in terms of providing meaningful benefits on a population level. However, there are some more targeted situations where the device has real potential benefits like monitoring for paroxysmal symptomatic arrhythmia. In addition, there are highly health literate patients for whom such data helps them feel more in control of their health.

Overall, the availability of this device over the counter is in all likelihood a double edged sword. Innovative users may, for example, help discover or develop novel applications for this technology that have meaningful benefits. For others, the availability of the device over the counter may drive over-testing or increased healthcare utilization driven by device artifact or benign findings (think “nonspecific ST-T wave change”).

At the end of the day, a combination of individual experimentation and systematic evaluation will be needed to guide how devices like the AliveCor Heart Monitor can be used in the right situation with the right patient to improve outcomes.