AliveCor mobile heart monitor receives FDA clearance

San Francisco-based AliveCor announced yesterday that its mobile ECG heart monitor has received FDA 510(k) clearance. Compatible with the iPhone 4 and 4S, clinical studies of the device have demonstrated its ability to record, display, store, transfer, and evaluate single-channel electrocardiogram (ECG) rhythms to accurately screen for cardiac arrhythmias, including atrial fibrillation.

Researchers tested the app running on an iPhone that allows for wireless recordings of rhythm strips of any duration, which are stored on the device and securely in the cloud for later analysis. AliveCor's low-power, proprietary communication protocol enables ECG data to be sent wirelessly from the heart monitor to the iPhone without pairing necessary between the iPhone and the device. 

The heart monitor currently is available for pre-sale to medical professionals in the U.S., with a price tag of $199. In early 2013, the company plans to begin selling the device in Europe. Announcement

Suggested Articles

The newly launched Center for Connected Health will be largest telehealth hub in the Philadelphia region, according to Penn Medicine.

The FDA commissioner wants to use additional funding under Trump's budget to advance digital health initiatives and integrate real-world data.

The FDA's approval of an app that uses AI to notify specialists of a potential stroke offers new possibilities for triage software that uses CDS.