FibriCheck is ready to enter the U.S. market with FDA-clearance!

After a rigorous investigation procedure by the Food and Drug Administration, FibriCheck is now FDA-cleared (K232804). This is an important milestone which supports our further development in the U.S. market. The FDA-clearance allows us to improve current U.S. care pathways and to provide millions of Americans with the ability to just use their smartphone to obtain easy and accurate heart rhythm measurements. These measurements can enable the early detection and monitoring of heart rhythm conditions such as atrial fibrillation.

FibriCheck’s FDA-clearance

The Food and Drug Administration provided its FDA-clearance for the entire FibriCheck ecosystem, including our patient-facing smartphone application, our algorithm powered by the latest generation of AI that has been trained on more than a million datasets, and our healthcare provider portal. This FDA-clearance allows healthcare providers in the U.S. to redraw their current pathways by offering a digital first solution, enabling hybrid care models which support them in better clinical decision making.

FibriCheck is the only FDA-cleared smartphone application with ECG equivalence in the U.S. 

During the past year, several algorithm updates provided substantial improvements to FibriCheck. Independent external validation studies showed that FibriCheck’s accuracy for detecting AF is excellent, with a sensitivity of 98.3% and a specificity of 99.9%. These significant performance gains and improved capabilities led to another meaningful achievement, as FibriCheck outperformed rivaling state-of-the-art devices for heart rhythm monitoring, such as the Apple watch ECG and the KardiaMobile 6-lead handheld ECG.

Thanks to the outstanding performance of 99% accuracy compared to gold-standard ECG in a recent clinical trial (NCT06282380), FibriCheck was FDA-cleared within the category of smartphone ECG devices, named the DXH category. This makes FibriCheck the only smartphone application using PPG-technology that is FDA-cleared with equivalence to ECG. Our patented technology also demonstrated an equal performance across different comorbidities and skin tones. 

Our next steps in the U.S. market

Since the beginning of this year, we have increased our presence in the U.S. by opening a New York office, participating in the world renowned MedTech Innovator and by collaborating with renowned European and U.S. hospitals such as Northwestern Medicine Chicago, the New York Presbyterian, the University of Oklahoma College of Medicine, Hospital East-Limburg and Antwerp University Hospital.

This FDA-clearance is an important stepping stone for the further development of our U.S. business activities. FibriCheck can now be prescribed in the U.S. and reimbursed using existing reimbursement codes. The clearance of the FDA for prescription use also plays an important part in our future goal to support the entire patient journey and to be able to offer FibriCheck over-the-counter in the United States. This would make it possible for anyone in need to follow up on their heart rhythm and the symptoms they’re experiencing, with or without their physician involved.

About FibriCheck

Our medically certified technology redefines the way cardiac arrhythmias are detected and managed. FibriCheck transforms consumer devices such as smartphones into FDA-cleared medical devices capable of detecting atrial fibrillation and other arrhythmias, without logistical challenges or a need for additional hardware. 

The data from FibriCheck’s intermittent and remote PPG-measurements is analyzed by our AI algorithm. The data is shared immediately with our physician portal, where healthcare providers can get an overview of their patients’ measurement results and gain insights into the heart rate, heart rhythm, and AF phenotype of their patients, including AF load, symptoms, symptom severity and symptom-rhythm correlation. 

Our technology is currently being used by over 1 million users and has been implemented in over 20 different clinical pathways throughout numerous hospitals all over Europe, the UK, Australia and the Middle East, thereby supporting healthcare providers in their clinical decision making. FibriCheck has proven to be clinically superior to traditional care pathways and has demonstrated to be a user-friendly and scalable digital solution that is able to decrease wait lists, reduce costs, and improve efficiency both for healthcare providers and patients.