AliveCor has received two additional FDA 510(k)-cleared indications for its personal ECG device. KardiaMobile is the only consumer ECG device with clearance to detect the three most common heart arrhythmias, atrial fibrillation (AFib), bradycardia, and tachycardia.
Devices that indicate an ECG reading as “unclassified” or “inconclusive” can cause frustration or concern for patients. KardiaMobile is the first personal ECG device that can reduce the number of such determinations. In addition, it is the only personal ECG device also able to detect AFib at heart rates above 120 and below 40 beats per minute.
Nearly all adults experience either bradycardia or tachycardia. Although these arrhythmias are often harmless, they can indicate heart disease or other conditions such as thyroid disease. A slow or fast heart rate may be asymptomatic or it may cause symptoms including dizziness or shortness of breath. Now, patients using the KardiaMobile device will be able to detect these arrhythmias and use the information during discussions with their physician.
Source: BioSpace, April 23, 2019