AliveCor's credit-card-sized ECG snags FDA clearance for 30-second arrhythmia detection

Thin is in for AliveCor: The personal electrocardiogram maker scored FDA clearance for its slimmest heart monitor yet, which is the size and shape of a credit card and aptly named the KardiaMobile Card.

Able to fit in a wallet for on-the-go ECG readings, the single-lead KardiaMobile Card offers medical-grade detection of six of the most common types of cardiac arrhythmia including atrial fibrillation, bradycardia and tachycardia. The device is designed to withstand weather, water and other regular wear and tear, which AliveCor says makes it the company’s most durable ECG offering yet.

Like many of AliveCor’s other portable heartbeat monitors, the slimmed-down device works by analyzing a user’s pulse through two designated thumb pads. Each reading is automatically sent via Bluetooth to the user’s smartphone, where it’s analyzed by AliveCor’s artificial intelligence algorithm.

Additionally, through the KardiaCare platform on their smartphones, users can compile their past readings and share them with their healthcare providers, track their weight, blood pressure and medication intake and access a comprehensive heart health report.

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With the FDA’s 510(k) green light—the agency’s first for a personal ECG of this size, according to the company—the KardiaMobile Card can now be purchased in the U.S. from AliveCor’s website for $149 plus an annual fee of $99 after the first year for continued access to KardiaCare.

“KardiaMobile Card delivers the most sophisticated AI in the most convenient form factor ever, putting the power of real-time ECG analysis directly in patients’ wallets and furthering our vision of becoming the 24/7 virtual cardiologist for patients when they’re not in front of their physician,” said AliveCor CEO Priya Abani.

In multiple studies of the KardiaMobile arrhythmia-detecting algorithm, the AI has demonstrated high accuracy levels, with one study producing a sensitivity rate of 96.6% and specificity of 94% in spotting signs of atrial fibrillation.

The studies have also shown that the portable ECG readers are straightforward enough for individual use. Almost 94% of participants in the same 2018 study reported they found AliveCor’s original KardiaMobile device easy to use, and about 64% said they’d prefer to continue using the device for their ECG needs rather than standard 12-lead ECG monitors.

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The Silicon Valley startup’s recent FDA clearance is the latest in a fairly constant stream of regulatory OKs. Just a few months ago, in July, it got the go-ahead to add QT prolongation monitoring to its six-lead KardiaMobile 6L device, which was first cleared in 2019.

In the months since, AliveCor has been busy upping its profile as a leader in ECG tech development. In October, it launched AliveCor Labs, an independent diagnostic testing facility offering reimbursable cardiac monitoring services to healthcare providers in the U.S. And just last month, it kicked off the new year by announcing the addition of several new executives including a chief clinical officer hailing from HP and a senior vice president of services plucked from the founding team of Amazon Care.