FibriCheck Enters US Market with FDA Clearance

FibriCheck is now the only FDA-cleared smartphone application for heart rhythm monitoring with ECG equivalence in the U.S.

July 24, 2024 — After a rigorous investigation procedure by the Food and Drug Administration, FibriCheck is now FDA-cleared (K232804). This is an important milestone which supports FibriCheck’s further development in the U.S. market. The FDA-clearance also allows FibriCheck 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

Qompium announced the FDA-clearance and commercial launch of FibriCheck for heart rhythm and heart rate measurements on the 24th of July 2024. With the FDA-clearance of the FibriCheck ecosystem, U.S. patients can now access FibriCheck on demand when prescribed by their physician. The FibriCheck ecosystem consists of a patient-facing smartphone application, an algorithm powered by the latest generation of AI that has been trained on more than a million datasets, and a healthcare provider portal. The FDA-cleared FibriCheck ecosystem allows healthcare providers to follow up on the heart health of their patients remotely without the need for additional hardware. The results of the heart rhythm measurements performed with the FibriCheck application are shared directly through FibriCheck’s physician portal. This allows healthcare providers to redraw their current pathways by offering a digital first solution, enabling hybrid care models to 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%.1 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.2

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. FibriCheck’s patented technology also demonstrated an equal performance across different comorbidities and skin tones.

FibriCheck ready to expand in the U.S. market

Since the beginning of this year, FibriCheck has increased its 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 FibriCheck’s 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 FibriCheck’s future goal to support the entire patient journey and to be able to offer FibriCheck over-the-counter in the U.S. 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.

Lars Grieten (CEO and co-founder) comments: “Receiving FDA clearance for a software-only application using consumer devices was a difficult challenge, but it showcases the competence and excellence of our team. This is just the beginning. Our achievement serves as a foundation for future growth as we continue to expand our capabilities based on our AI advancements. We are dedicated to redrawing the blueprint of heart rhythm disorder monitoring and management by paving the way to a healthier future, delivering the right diagnosis to the right person at the right time. Together, we dream of making solutions that are not dependent on specific hardware or devices, so that digital health can truly fulfill its promise.”

For more information: www.fibricheck.com