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The FDA approves a new EKG Reader in the form of an Apple Watch Band that detects abnormal heart rhythm and AFib



According to a new report published this morning, the Food and Drug Administration has just cleared AliveCor's Kardiaband EKG reader as the first medical device accessory for the Apple Watch. Up until now, there was AliveCor's KardiaMobile device that worked with your iPhone and paired with an app to detect abnormal heart rhythm and atrial fibrillation (AFib). The new Apple Watch accessory, Kardiaband, clicks into a slot on the Watch band to do the same thing as noted in the video below.  



While Europe has been able to use a version of the Kardiaband for Apple Watch for some time now, that convenience is now availabel State side thanks to the new FDA approval. The device can now be used in the U.S., marking the first time an Apple Watch accessory will be able to be used as a medical device in the States.


Performing an ECG


Kardia for Apple Watch is designed to let you take an ECG anywhere, for any reason. Using your Kardia Band sensor, you can immediately take an ECG and in 30 seconds receive a result from our FDA-cleared ECG analysis algorithms. You can also forward your ECG to your doctor for a professional opinion.  

2 alivecor

KardiaBand is a self-contained, FDA-cleared, miniaturized ECG device. Powered by an internal lithium battery with a lifetime of 1-2 years, the sensor in KardiaBand is always ready to use - with the recording screen open on your Apple Watch, simply touch your index finger to the KardiaBand sensor to start a recording.


The live view shows your ECG in real time, and after a 30 second recording, our FDA-cleared machine learning algorithms run directly on Apple Watch and immediately report a result: Normal if our algorithms indicate your ECG is normal, Possible Atrial Fibrillation if our algorithms detect signs that you may be experiencing AF, Unclassified if the signal falls outside the range we can confidently classify, and Unreadable if there was too much interference or motion artifact in the signal to analyze.


Beyond detection of arrhythmias, AliveCor is working on other technologies that utilize the power of machine learning and wearable ECG devices like KardiaBand to expand the clinical and diagnostic significance of the ECG even further. For example, in partnership with the Mayo Clinic, we're working towards reliable detection of life-threatening electrolyte abnormalities, like hyperkalemia, directly from an ECG, and screening tools that may one day enable detection of genetic abnormalities, like congenital long QT syndrome. The ECG has been around for more than 100 years. New techniques like machine learning may enable us to see what was formerly invisible to human eyes, and this may save millions of lives.


3 Artial Fibrillation  Apple Watch 3

Apple's COO Jeff Williams highlighted some of the new Apple Watch Series 3 features on the Apple Watch Series 3 in respect to the heart app monitoring, he announced that Apple was starting a new 'Apple Heart Study.' It will use data from Apple Watch 3 and analyze arrhythmias including AFib and notify users. This study is being conducted by Standford Medicine and Apple is working with the FDA. The first phase of the Apple Heart Study in the U.S. only on the App Store.


Today's news of the FDA approved Kardiaband will go a long way in assisting Apple Watch 3 user's heart health and advancing Apple's work regarding atrial fibrillation.


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