FibriCheck—a smartphone or smartwatch app capable of measuring a patient’s heart rhythm and detecting possible arrhythmias—has been cleared by the US Food and Drug Administration (FDA).
The clearance in the DHX category of smartphone electrocardiogram (ECG) devices means that US patients can access FibriCheck on demand when prescribed by their physician.
FibriCheck consists of a patient-facing smartphone application, an algorithm powered by artificial intelligence (AI) trained on more than one million datasets and a healthcare provider portal. Data from FibriCheck’s intermittent and remote photoplethysmography (PPG)-measurements is analysed by FibriCheck’s AI algorithm.
The data are shared with FibriCheck’s physician portal, where healthcare providers can get an overview of their patients’ measurement results and gain insights into the heart rate, heart rhythm, and atrial fibrillation (AF) phenotype of their patients, including AF load, symptoms, symptom severity and symptom-rhythm correlation.
Lars Grieten, CEO and co-founder of FibriCheck, commented: “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 fulfil its promise.”
