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FDA approves mobile ECG for iPhone
AliveCor Inc. today announced FDA 510(k) clearance and CE mark conformity for its iPhone-compatible mobile ECG that allows physicians to remotely monitor patients’ CV health.
The mobile ECG is intended for use by licensed medical professionals to record, display, store, transfer and evaluate single-channel ECG rhythms, according to a press release issued by the manufacturer. The rhythm strips can be of any duration and are stored on the iPhone and securely in the cloud for later analysis, sharing and printing through the secure AliveCor website. The ECG data are sent wirelessly from the device via a low-power, proprietary communication protocol and does not require pairing between the iPhone and the device.
The device incorporates electrodes into a case that snaps onto the back of an iPhone 4 or iPhone 4S. The ECG is then used by launching the corresponding AliveECG app, holding the device in a relaxed state and pressing fingers from each hand to each of the two appropriate electrodes on the device. Physicians can also use the device to obtain an ECG by placing it on the chest, according to information in the release.
For more information, visit the AliveCor website.