The KardiaMobile 6L builds upon its predecessor with a third electrode placed on its back side, allowing cardiologists better insight into device owners' arrhythmias.

FDA clears AliveCor's six-lead smartphone ECG

By Dave Muoio
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Mobile consumer ECG maker AliveCor announced today that its long-teased six-lead ECG device has been cleared by the FDA and will be available to customers in June of this year.

“[The KardiaMobile 6L clearance] is a big deal for us, and it’s important for patients and physicians because they will be able to get a materially improved view into patients’ hearts,” Dr. Jacqueline Shreibati, chief medical officer at AliveCor, told MobiHealthNews. “It allows visibility into certain arrhythmias that was never available to consumers until now.”

The KardiaMobile 6L generally resembles the standard KardiaMobile and uses a similar app-driven interface. However, in addition to placing their thumbs on the device’s front electrodes, a third node on the back is pressed against the user’s knee or ankle. By creating this so-called “Einthoven Triangle” (named after the ECG’s inventor), the device is able to provide cardiologists with six different perspectives on the heart’s electrical activity, helping them better identify arrhythmias and diagnose heart conditions.

“We heard from our users and from physicians over the years that while they appreciate the convenience and accessibility and the ease of KardiaMobile, there are scenarios where there are clear limitations of these single-lead ECGs, and we are responsive to that type of feedback,” Shreibati said. “For some customers — particularly those under the care of a cardiologist, who are being monitored with suspected arrhythmia or known arrhythmia — we are answering that feedback with this device that provides more insights into the heart.”

The new device will have the same software functionalities available for the single-lead KardiaMobile, including the KardiaAI bradycardia and tachycardia detection features announced by AliveCor last month. Shreibati also noted that the company’s algorithms will allow the new personal health tool to become even more useful to consumers and physicians with each use.

“With [KardiaMobile 6L’s] use, we will be able to develop improved AI to help physicians with improved informed decision making [and] improved diagnostics,” she said. “It’s a pretty exciting feedback loop of users recording their ECGs, and that can inform the data analytics to improve the diagnostic capabilities of our software. It’s great for physicians and our end users alike.”

The six-lead product will replace the standard KardiaMobile as the default device for thoses who subscribe to AliveCor’s KardiaPro service, Shreibati said, and bulk purchase options will be available for enterprise customers. For consumers, the device is currently available to preorder online for $149.

WHY IT MATTERS

While AliveCor may have been a frontrunner in the personal ECG space, the company has recently been joined by Apple, Withings and others looking to include more health features into their consumer wrist-worn devices. While Shreibati noted that her company still sees value in wearable ECGs and is “making improvements” and “working diligently” on updates to its own Kardia Band product, the release of a smartphone-compatible six-lead device will help AliveCor stand out in the fast-paced market.

“Over the past couple months, you can see that we’ve been very busy at AliveCor, and we think that the delivery of more and more medical services outside of the clinical environment is inevitable,” Shreibati said. “It's inevitable as Amazon, as inevitable as Uber, and really the only question is going to be which companies are able to deliver the right products at the right time. As long as we continue to innovate as we have, I think we’re going to be in great shape.”

WHAT’S THE TREND

In addition to the past few months’ clearances, AliveCor’s platforms were highlighted in a number of research studies presented at the American Conference of Cardiologists in March. In particular, one of these was a Mayo Clinic investigation of the six-lead device that placed it on par with a traditional 12-lead ECG.

The last few months also saw former CEO Vic Gundotra step down from his position as the company’s head, citing personal reasons, and an announcement that the company had received debt funding from Oxford Finance to secure its continued growth.

And, as mentioned before, AliveCor’s devices are seeing stiff competition from the latest version of the Apple Watch, which was updated with its own ECG reading and irregular rhythm detection capabilities in December.

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