FDA Grants AliveCor Clearance to Detect Bradycardia and Tachycardia on KardiaMobile
Posted on April 24, 2019 by Medtech[y] Staff
AliveCor, developer of consumer ECG devices, announced two additional 510(k) cleared indications for their KardiaMobile, which now allow the device to detect the three most common heart rhythms.
Originally cleared to detect Atrial Fibrillation (AFib) and normal sinus rhythm, the device can now detect and show ECG results for Bradycardia and Tachycardia. Bradycardia is an arrhythmia that means "slow heart" and is between 40-50 beats per minute while tachycardia means "fast heart" and is between 100-140 beats per minute.
Getting the two additional 510(k) cleared indications make KardiaMobile the only consumer ECG device FDA cleared to detect the three most common heart arrhythmias.
"No other consumer ECG device in the world, can tell you more about your heart than KardiaMobile," said AliveCor Chief Executive Officer, Ira Bahr. "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."
Bradycardia and Tachycardia are often benign but the arrhythmias can be an indication of other heart disease or conditions such as thyroid disease.
As a current KardiaMobile user without a history of AFib, but with a history of Tachycardia, having the ability to identify these abnormal heart rhythms and send them to my cardiologist for feedback is a game changer. From there, the physician can potentially make a clinical determination without me having to come in for an office visit.
According to the Kardia App update notes, the update will also be added to the KardiaBank in early May. Additionally, the company announced that device replacement is included for Premium Users in the U.S. and a lost or stolen device can be replaced for $19.99.
"Tachycardia and bradycardia are common because they are often the body's natural response to everyday life, from physical activity and sleep to emotions and overall health," said Dr. Jacqueline Shreibati, CMO of AliveCor. "While we have traditionally focused on the patient empowerment that comes from increased awareness of atrial fibrillation, we are excited to give all of our users more actionable insights into their heart health."
AliveCor also recently announced that they have signed an agreement with Beijing Dream Tree Medical Technology to to distribute ECG technology to patients in China.
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