AliveCor Heart Monitor for smartphones now approved by the FDA

Smartphone health apps may have revolutionized personal health monitoring for a lot of people though regular health monitors still like hot cakes. However, the new smartphone Heart Monitor by AliveCor seeks to combine the ease of health app use with a hardcore hardware back monitor that makes it easier for folks with heath condition to keep track of their ECG rhythms without carrying an extra monitor around with them.

AliveCor Heart Monitor for smartphones now approved by the FDA
AliveCor Heart Monitor for smartphones now approved by the FDA

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AliveCor Heart Monitor for smartphones now approved by the FDA
AliveCor Heart Monitor for smartphones now approved by the FDA

The case is designed to attach to the back of the iPhone 4 or 4S and syncs with an app on the device keeping track of your heart rate and rhythms. To create a Lead I ECG through the case, the user has to rest the fingers of both hands on the electrode built into the case. As the case inputs the data for the patient, the app records, monitors and rates heath rates and rhythms for evaluation.

The case is designed to connect to the phone wirelessly and the self-powered Class II medical device has been found to be around 94-100 percent accurate in generating single-channel ECGs in clinical studies. AliveCor is currently researching the effectiveness of the health monitor in diverse applications such as rhythm morphology changes induced by stress, preventive pediatric care, PA/RN data collection, QT duration response monitoring induced by medication, multi-specialty care integration, long-term atrial fibrillation monitoring and post-ablation follow up monitoring.

However, in its current form, the health monitor has been approved for sale by the US FDA. The health monitoring smartphone case is currently available for pre-order at $199 a pop and is scheduled to make its market launch in January 2013 in the United States. International release and pricing for the health monitor has not been announced just yet.

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