AliveCor has secured approval from the US Food and Drug Administration (FDA) for its KardiaMobile six-lead personal electrocardiogram (ECG) device.
Claimed to be the world’s first six-lead personal ECG device, the KardiaMobile 6L will provide physicians with a detailed view of patients’ hearts, including visibility into certain arrhythmias that are major indicators of cardiovascular disease.
AliveCor CEO Ira Bahr said: “KardiaMobile 6L is the most clinically valuable personal ECG ever created, and another significant step in AliveCor’s march to making heart care more convenient, more accessible, and less expensive than ever before.”
KardiaMobile six-lead device is said to be consistent in design with AliveCor’s existing KardiaMobile.
An additional electrode on the bottom is provided, in addition to the two electrodes on the top of the device.
The user has to place thumbs on each of the two top electrodes, while the bottom electrode on her left knee or ankle.
In cardiology, this formation is called as the Einthoven Triangle, which enables cardiologists to view electrical activity in the heart from six perspectives or leads.
A six-lead ECG offers physicians with a better view of the heart compared to a single lead ECG, helping to detect a wide range of arrhythmias and other heart conditions.
The company plans to make KardiaMobile 6L device available to the customers in June.
Scripps Research Translational Institute director and founder Dr Eric Topol said: “I am impressed with the quality and simplicity of 6-lead smartphone ECG tracings which will unquestionably sharpen our ability to diagnose heart rhythm and conduction abnormalities. It’s a welcome and needed step forward for mobile heart diagnostics.”
AliveCor is involved in the creation of FDA-cleared machine learning techniques to facilitate proactive heart care.
KardiaMobile is a major clinically validated mobile ECG solution recommended by cardiologists and used by people for accurate ECG recordings, said the company.
When paired with the Kardia app, the KardiaMobile offers instant analysis to detect atrial fibrillation, bradycardia, tachycardia and normal rhythm in an ECG.