The Food and Drug Administration (FDA) has cleared KardiaMobile (AliveCor), a personal ECG device, for use in detecting bradycardia and tachycardia.
This portable EKG reader, which works with smartphones and tablets, was first cleared by the FDA in 2017 for detection of normal sinus rhythm and atrial fibrillation. When paired with the Kardia app, the device now provides instant analysis for 3 of the most common cardiac arrhythmias. Through the KardioPro platform, clinicians are able to remotely monitor patients, which the Company believes helps support clinical decision making and may help reduce unneeded in-person visits.
“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,” said AliveCor Chief Executive Officer, Ira Bahr. “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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For more information visit Alivecor.com.
This article originally appeared on MPR
