News & Insights

July 24, 2024
The Food and Drug Administration (FDA) cleared the FibriCheck application and portal for heart rhythm monitoring FibriCheck is now the only FDA-cleared smartphone application for heart rhythm monitoring with ECG equivalence in the U.S. FDA-clearance is an important stepping stone for FibriCheck’s further U.S. business development HASSELT - 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.