FDA clears world’s first credit-card-sized personal ECG device

USA – AliveCor has launched KardiaMobile Card, the latest generation of personal electrocardiogram (ECG) technology.

At the size of a credit card, it is the thinnest, lightest ECG device ever created and fits in any wallet. The approval follows the most recent launch of Philips’ first full-service, at-home 12-lead electrocardiogram (ECG) solution for use in decentralized clinical trials.

The FDA-approved KardiaMobile Card detects six of the most common heart arrhythmias in 30 seconds, which no other personal ECG can do, making it the most important card in your wallet.

The single-lead KardiaMobile Card, which fits in a wallet for on-the-go ECG readings, offers medical-grade detection of six of the most common types of cardiac arrhythmia, including atrial fibrillation, bradycardia, and tachycardia.

With the FDA’s 510(k) approval, the KardiaMobile Card is now available in the United States from AliveCor’s website for US$149, plus a US$99 annual fee for continued access to KardiaCare after the first year.

The FDA approval granted to the Silicon Valley startup is the latest in a steady stream of regulatory approvals.

It received approval just a few months ago, in July, to add QT prolongation monitoring to its six-lead KardiaMobile 6L device, which was first cleared in 2019.

In the months since, AliveCor has worked hard to raise its profile as a pioneer in ECG technology development.

It launched AliveCor Labs in October, an independent diagnostic testing facility that provides reimbursable cardiac monitoring services to healthcare providers in the United States.

And, just last month, it began the new year by announcing the hiring of several new executives, including a chief clinical officer from HP and a senior vice president of services from Amazon Care’s founding team.

How Kardiamobile card works

The KardiaMobile Card connects via Bluetooth to a smartphone to detect six of the most common arrhythmias. It provides users with access to cardiologist-assisted ECG analysis, monthly heart health reports, and automatic sharing of ECG recordings.

AliveCor based the device’s algorithm on its AI-enabled Kardia technology and designed the device to withstand weather, water, and wear and tear, making it the company’s most durable ECG offering to date and allows users to take an ECG recording at any time and from any location.

The KardiaMobile Card platform includes a one-year subscription to KardiaCare, a heart health service that provides over 130,000 members with a suite of advanced features to help them manage and understand their health.

KardiaMobile Card is being launched at a critical juncture in which both heart arrhythmias and hypertension, a risk factor for atrial fibrillation and other arrhythmias, are on the rise.

These cardiac conditions have far-reaching economic consequences. The annual cost of hypertension to the US healthcare system is estimated to be US$316 billion.

Furthermore, it is estimated that 80 percent of all cardiovascular disease is preventable, emphasizing the importance of making real-time data available to patients.

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