AliveCor Heart Monitor Receives Over-the-Counter Clearance

Provides individuals a way to participate in their heart health


February 13, 2014
AliveCor Heart Monitor FDA EP Lab ECG Cardiac Diagnostics Mobile Remote
February 13, 2104 — The U.S. Food and Drug Administration (FDA) granted AliveCor Inc. over-the-counter (OTC) clearance for the AliveCor Heart Monitor, a single-channel ECG (electrocardiogram) recorder, previously available by prescription only. The device is available for pre-order purchase with shipments beginning in March.
The AliveCor Heart Monitor provides people with suspected or diagnosed heart conditions, and those at risk of heart conditions, the ability to track their heart health anytime, anywhere, at an affordable cost. Health professionals and patients have reported using the device to detect, monitor and analyze irregular heart rhythms.
The AliveCor Heart Monitor’s medical-grade ECG recordings can be shared directly with a user’s physician, or sent to a U.S. board-certified cardiologist or a U.S. based cardiac technician. It does so through AliveInsights, an analysis service that offers expert review of ECGs directly through the free AliveECG app. Recordings are then reviewed and analyzed providing users with a more complete picture of their current heart health.
The AliveCor Heart Monitor is a FDA cleared mobile ECG recorder that supports both iPhone and Android smartphones. It records, displays, stores and transfers single-channel ECG rhythms wirelessly. With secure storage in the cloud, users can access their data confidentially anytime, anywhere, and can grant access to their physician. The Heart Monitor is available for purchase in the United States by health professionals, patients with prescriptions and now over-the-counter.
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