FDAnews Device Daily Bulletin

AliveCor Releases Smartphone ECG System

Nov. 21, 2013

San Francisco-based AliveCor Monday announced the U.S. launch of its AliveInsights app, which allows patients to receive feedback on electrocardiogram data gleaned from the company’s heart rate and rhythm monitor. The data can then be shared with a physician, a cardiac technician or a U.S. board-certified cardiologist.

The ECG device itself consists of a case or a single-use, double-sided universal adapter that can be connected to a smartphone or tablet, said AliveCor spokeswoman Janice Jones. The user starts by downloading the AliveCor ECG app from the Apple app store or Google Play, then creates an account and places their hands over the adapter. The adapter read the user’s heart rate and rhythm and stores that information.

A clinical analysis and report by a certified cardiologist costs $12 and is provided within 24 hours, Jones told Device Daily Bulletin. A preliminary finding by a cardiac technician can be provided in about 30 minutes for $5; the same preliminary report is available for just $2 on a 24-hour turnaround.

The ECG adapter for Apple received 510(k) clearance from the FDA in October 2012 and is also available in the UK and Ireland. AliveCor expects the Android version, cleared in September, to become available next month. – Lena Freund

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