AliveCor gets FDA clearance for measuring QTc intervals using KardiaMobile 6L

Kardiamobile 6L EKG

AliveCor announced this morning that it has received FDA clearance for the measurement of QTc interval.

US Food and Drug Administration provided 501(k) clearance for the use of KardiaMobile 6L device to calculate patient’s QTc interval.

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The QTc is a heart rate corrected interval that reflects the integrity of the heart’s electrical recharging system. QT prolongation can stem from congenital long QT syndrome, many disease states or electrolyte abnormalities. 

Patients with a prolonged QTc are at greater risk for their hearts to go into a potentially dangerous arrhythmia called Torsades de Pointes which can lead to sudden cardiac arrest.

QT prolongation is a potential side effect of more than 100 FDA-approved medications including certain antiarrhythmic medicines, cancer therapies, antifungals, antipsychotics, antidepressants, antibiotics, multiple sclerosis (MS) medications, and opioids, among other categories.

QT or QTc intervals that are long, suggest abnormal effects on the myocardium.AliveCor 6 lead ECG

The AliveCor 6L device is an FDA-cleared device available for $150, that allows users to record an EKG anytime.

The six leads on the device provides you more heart data making it easy to detect aFIB, Bradycardia and Tachycardia.

Save your EKGs on your phone or send them to your doctor for review remotely. Use your EKGs to track your heart activity over time and discuss with your care team at your convenience.

Users can purchase using an FSA or HSA account (please confirm coverage with your insurance provider) in the US.

Apple Watch and QT intervals

Other wearables such as the Apple Watch have been used as well for determining QT interval. During the peak of the pandemic, studies recommended using Apple Watch for remote monitoring of QT intervals. Apple Watch 6 lead ECG readings

Although the Apple Watch does not have 6 leads, one could still get accurate readings by placing the watch on different parts of the body.Apple Watch QTc calculator

There are also third-party apps on the Apple store that allows users to calculate QTc based on the data from their Apple Watch

.AliveCor and Apple have been engaged in a patent dispute over the Apple Watch ECG functionality. AliveCor has recently filed a case with the International Trade Commission against Apple.

I am a technologist with years of experience with Apple and wearOS products and have a Bachelor’s degree in Computer Science. In my day job, I advise fortune 500 companies with their digital transformation strategies and also consult with numerous digital health startups in an advisory capacity. I'm VERY interested in exploring the digital health&fitness-tech evolution and keep a close eye on patents, FDA approvals, strategic partnerships and developments happening in the wearables and digital health sector. When I'm not writing or presenting, I run with my Apple Watch or Fossil Gen 5 LTE and keep a close eye on my HRV and other recovery metrics.

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