AliveCor iPhone Based EKG Heart Rate Monitor Approved for Sale to Patients

February 18, 2013

The iPhone based EKG Heart Monitor from ALiveCor has been approved by the FDA (US Food and Drug Administration) for sale to patients directly. However, the iPhone add-on, a class II medical device, can only be sold on a prescription from a physician. The device snaps onto the iPhone 4 or 4S like a case and wirelessly communicates with the app on the phone. No pairing between the iPhone and the Heart Monitor is required.

AliveCor-ECG-HeartRateMonitor

The device was approved for sale to physicians and licensed medical professionals in the US earlier. AliveCor says that its Heart Monitor has been used in several clinical trials along with rigorous testing through numerous medical professionals and in many on-going studies at the University of Oklahoma Health Sciences Center, USC’s Center for Body Computing, and other institutions.

Abstracts were presented in 2012 at three major cardiology meetings, demonstrating usability, accuracy, and the ability to use the device for community screening.

AliveCor’s Heart Monitor is cleared by the FDA for sale in the U.S. to licensed medical professionals and prescribed patients, to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms.

The device is (1) easy to use, (2) found to be accurate in clinical trials, (3) powerful and portable, and (4) costs only $199 per piece. Note that the price does not include the iPhone.

The Heart Monitor does not use power from the iPhone, but utilizes a 3.0V coin cell battery that will take up to roughly 10,000, 30-second ECGs before needing replacement, claims the company. The Heart Monitor also uses AliveCor’s proprietary wireless communication protocol to communicate with the app, and requires no pairing between the iPhone and the Heart Monitor. For more information, please visit the Alivecor website.

The device may be a great addition to seniors with cardiac conditions who are living in their homes and using home health care assistance. If you think that you or your loved one may use the device, check with your physician. This is yet another example of a contribution from recent mHealth initiatives aiding elders Aging In Place.

 

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