Tuesday, May 21, 2024

FDA clears KardiaMobile, an ECG device to detect three heart arrhythmias

Some months ago, when an Apple Watch Series 4 came out with an in-built ECG (electrocardiogram) monitor, most people were overjoyed, especially Apple Watch wearer and fitness enthusiasts. ECG monitor detects irregular heart rate and this early detection of atrial fibrillation (AFib) could prevent a serious medical event.

Now, AliveCor- the leader in FDA-cleared consumer electrocardiogram technology (ECG), has received FDA clearance for two more analyses on its AI-powered KardiaMobile electrocardiogram (ECG) device. It is a personal device that detects two other relatively common conditions, bradycardia (where your heart rate dips to 40-50BPM) and tachycardia (a jump to 100-140BPM).

KardiaMobile, a portable ECG reader works with smartphones and tablets. When the device first launched, it used to detect Atrial Fibrillation (AFib) and Normal Sinus Rhythm. But now the two more additions make it the first of its kind.

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.

A slow or fast heart rate may be asymptomatic or cause symptoms such as dizziness or shortness of breath. With KardiaMobile, people will now be able to detect these arrhythmias and use the insight to inform conversations with their doctor.

How does it work?

The device is very easy to use. All you need to do is just put your fingers on Kardia Mobile’s pads—no wires, patches or gels required. That’s it, you are all set to take a medical-grade ECG in just 30 seconds. Results are delivered right to your smartphone.

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.

However, AliveCor also highlighted that this will only help you in an informal conversation with your doctor, not replace them.