AliveCor heart monitoring smartphone case cleared by FDA
AliveCor’s smartphone Heart Monitor has received FDA approval and will go on sale to healthcare professionals in the United States in January 2013. The AliveCor Heart Monitor allows the recording, display, storing, transferring, and evaluation of single-channel electrocardiogram (ECG) rhythms using an iPhone 4 or 4S.
The Class II medical device consists of a self-powered case that attaches to the back of an iPhone, which is running the associated heart monitor app. The phone and case communicate with one another wirelessly, though the phone doesn't need to be paired to the device. To generate a Lead I ECG, the patients rests the fingers of each hand on the electrodes on the rear of the device and, once the connection is made, the app monitors and records heart rhythms and rates for evaluation.
Clinical studies have shown an accuracy of the device in single-channel ECGs of 94 to 100 percent. The company is continuing research on the device regarding its effectiveness in monitoring post-ablation follow up, long-term atrial fibrillation monitoring, multi-specialty care integration, medication-induced QT duration response monitoring, expanding PA/RN data collection abilities. preventive pediatric care and stress induced rhythm morphology changes.
The AliveCor Heart Monitor is priced at US$199 and is currently available for pre-order for U.S. customers ahead of the January 2013 release date.