FibriCheck Gains FDA Clearance for its Heart Rhythm AI Tech

The U.S. Food and Drug Administration (FDA) has cleared FibriCheck’s algorithm that turns a smartphone into a heart rhythm measurement tool. 
 
The FDA’s clearance covers the entire FibriCheck ecosystem, including the company’s patient-facing smartphone application, its AI-powered algorithm (trained on more than 1 million datasets), and its healthcare provider portal. This authorization enables U.S. healthcare providers to redraw their current pathways by offering a digital first solution that fosters hybrid care models and helps improve clinical decision-making.
 
FibriCheck is a smartphone application that allows people to check their heart rhythm without any medical equipment. The app is registered as a full-fledged medical device and is easy to use: Patients simply place a finger over their smartphone’s camera for 60 seconds and the company’s algorithms evaluate results for signs of heart rhythm conditions such as atrial fibrillation (AF). 
 
FibriCheck reportedly is the only FDA-cleared smartphone application with ECG equivalence in the United States. 

“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,” FibriCheck CEO Lars Grieten said. “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.”
 
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 98.3% sensitivity and a 99.9% specificity. These performance gains and improved capabilities led to another achievement, as FibriCheck outperformed rival devices for heart rhythm monitoring, such as the Apple watch ECG and the KardiaMobile 6-lead handheld ECG, according to company executives.
 
FibriCheck’s patented technology also demonstrated an equal performance across different comorbidities and skin tones. 
 
Since the beginning of this year, Belgium-based FibriCheck has increased its U.S. presence by opening a New York office, participating in the MedTech Innovator, and collaborating with renowned European and U.S. hospitals such as Northwestern Medicine Chicago, New York Presbyterian, the University of Oklahoma College of Medicine, Hospital East-Limburg and Antwerp University Hospital.
 
FibriCheck’s 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 the firm’s AI algorithm. The data is shared immediately with FibriCheck’s physician portal, where healthcare providers can find an overview of patients’ measurement results and gain insights into their heart rate, heart rhythm, and AF phenotype, including AF load, symptoms, symptom severity, and symptom-rhythm correlation. 
 
FibriCheck’s technology is currently being used by more than 1 million users and has been implemented in over 20 different clinical pathways throughout numerous hospitals in Europe, the United Kingdom, Australia, and the Middle East.