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It’s great that you’re keeping track of your heart health, and it’s only right that you want to know how accurate your results are. At FibriCheck, our continuous efforts to live up to the high standards of our medical certification and our team of experienced reviewers guarantee the accuracy of your measurements. In this article, we’ll run you through what that means, and how you can be sure that your measurements are trustworthy.

FibriCheck is a CE-class IIa app and is FDA-cleared, but what does that mean?

FibriCheck is the world’s first medically certified application capable of detecting atrial fibrillation and other heart rhythm disorders, which decreases the risk of serious consequences such as stroke.

Medical certification is important, as it ensures you that our app is safe to use and that it provides accurate and reliable information. We received our medical certification label after undergoing a series of tests and evaluations by medical professionals, who reviewed our app and tested it for a number of criteria, such as: 

  • safety
  • accuracy
  • quality
  • efficacy
  • accessibility 
  • user-friendliness
  • data privacy
  • security

The certifications for medical devices are usually granted by regulatory bodies such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), who have established guidelines and standards for evaluating health apps. After going through the process, our app has been CE-certified and FDA cleared.

How does FibriCheck analyse the measurements?

FibriCheck can detect the presence of atrial fibrillation and other cardiac arrhythmias with the help of its clinically validated and certified algorithm. Through ongoing clinical studies and the input of new data, our algorithm keeps learning and gets better all the time. Intervention from our clinical reviewers provides the necessary oversight to ensure that the measurements live up to the highest standards.

Got any more questions regarding the accuracy of our medical application? Our support team is happy to help!

Created on June 28th, 2023 at 03:17 pm

Last updated on October 23rd, 2023 at 12:32 pm

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