AliveECG large AliveCor iPhone ECG Receives FDA Clearance


by SHIV GAGLANI on Dec 4, 2012 • 2:06 pm

By now most Medgadget readers are probably familiar with the iPhone ECG, now known as the AliveCor Heart Monitor, a case that wirelessly connects to your smartphone and sends it one-lead electrocardiogram data. If you’d like a quick refresher, here’s the demo we received at last year’s mHealth Summit and an article describing the clinical findings that AliveCor presented at the American Heart Association’s annual meeting earlier this year.

AliveCor ECG AliveCor iPhone ECG Receives FDA Clearance

We recently learned from AliveCor that they have received FDA 510(k) Class II Medical Device clearance. Powered by a 3.0V coin cell battery that can “take up to 12,000, 30-second ECGs before needing replacement,” the case is now available for pre-order on AliveCor’s website for $199. This is the same price as their veterinarian- and pet owner-targeted product, which came out earlier this year.

In terms of use cases beyond the “cool factor,” it enables healthcare providers to have quick and near-ubiquitous access to one-lead ECG and heart rate data. They are continuing to work on expanding the use cases and hope to have a consumer version that may be “prescribed” and potentially sold for a lower price point (~$99). According to the company:

Research studies currently in progress to explore effectiveness in the following:

  • Post-Ablation follow-up
  • Long-term Afib remote monitoring
  • Multi-specialty care integration
  • Medication-induced QT duration response monitoring
  • Expanding PA/RN data collection abilities
  • Preventive pediatric care
  • Stress induced rhythm morphology changes

Product page: AliveCor’s Heart Monitor…

Press release: AliveCor’s Heart Monitor for iPhone Receives FDA Clearance


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