Medical Device Firm AliveCor’s Six-Lead Smartphone ECG Device Gets FDA Clearance

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Medical_Device-Firm-AliveCors-Six-Lead-Smartphone-ECG-Device-Gets-FDA-Clearance Medical Device Firm AliveCor's Six-Lead Smartphone ECG Device Gets FDA ClearanceAliveCor, a California-based medical device company that provides ECG hardware and software for consumer mobile devices, has received FDA clearance for its long-tested six-lead ECG device, KardiaMobile 6L. The iOS and Android-compatible KardiaMobile 6L will be available to customers by June this year. The device generally follows the standard KardiaMobile and leverages a similar app-driven interface.

According to the reports, KardiaMobile 6L can record heart activity on six different leads at once – I, II, II, aVL, aVR, and aVF, as well as it can identify atrial fibrillation (AFib), bradycardia – abnormally low heart rate and tachycardia – abnormally high heart rate.  It also promises to detect other arrhythmias that could indicate heart disease. In a statement, AliveCor CEO Ira Bahr said that “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 6L will have the similar functionalities that available in the single-lead KardiaMobile, the KardiaAI bradycardia, and tachycardia detection features, which was introduced last month, as reports noted.

The new device has three electrodes, requires each hand’s thumbs to make contact with that, and an ankle or knee on the bottom. The device takes the 30-second reading time that can be shared with a caregiver subsequently. AliveCor also created the first Apple Watch ECG watch strap, Apple included ECG on the watch itself a year before. For enterprises, there are huge purchases options will be available for the iOS and Android-compatible KardiaMobile 6L device, while it’s currently available to preorder online for USD149 to consumers.