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An exciting personal ECG device gets FDA Clearance

personal ecg device fda clearance

In a first, KardiaMobile – the first personal ECG device which can detect three kinds of heart arrhythmias, has been cleared by the FDA. The device is from AliveCor, a leading healthcare and AI company which has been innovating with ECG hardware and software.

The personal ECG devices till now have mostly been able to detect only one type of heart arrhythmia: atrial fibrillation. But AliveCor’s KardiaMobile is capable of more as it can detect two other kinds of heart conditions: Bradycardia (heart rate dips under 50 BPM) and Tachycardia (heart rate jumps over 100 BPM). These symptoms sometimes indicate an underlying heart condition and will prove helpful for the general public and patients.

Although the technology is still not as sophisticated as ECG it would be still useful and reduce the number of inconclusive ECG results. AliveCor’s CEO Ira Bahr in statement said: “Until today, patients have been frustrated when devices label their ECG reading as 'unclassified' or 'inconclusive.' Starting today, KardiaMobile is the first personal ECG device that can begin to materially reduce the number of those determinations. Critically, KardiaMobile is also the only personal ECG that can detect Atrial Fibrillation at heart rates above 120, and heart rates below 40.”

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