AliveCor said yesterday that it won expanded FDA 510(k) clearance indications for its KardiaMobile personal ECG device, now cleared for detecting bradycardia and tachycardia.
The Mountain View, Calif.-based company’s KardiaBand is a wrist-worn electrocardiogram device previously cleared to detect atrial fibrillation and normal sinus rhythm.
“No other consumer ECG device in the world, can tell you more about your heart than KardiaMobile. 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,” CEO Ira Bahr said in a press release.
AliveCor said that the device can now provide instant analyses to indicate arrhythmias that are not AF and that are between 40-50 beats per minute, or bradycardia, or between 100 and 140 beats per minutes, or tachycardia.
“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. 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,” CMO Dr. Jacqueline Shreibati said in a prepared statement.
In January, AliveCor landed a $20 million loan from Oxford Finance.
