FibriCheck, a spin-out from the DigitalHealth.London Accelerator, announces Food and Drug Administration (FDA) clearance and commercial launch of its technology in the United States. Its medically certified technology uses consumer devices and redefines the way cardiac arrhythmias are detected and managed..
After a rigorous investigation process by the Food and Drug Administration (FDA), FibriCheck is now FDA cleared (K232804). With 99% accuracy compared to the gold standard electrocardiogram (ECG) in a recent clinical trial (NCT06282380), FibriCheck has been cleared by the FDA specifically in the category of smartphone ECG devices, namely the DXH category. FibriCheck is now the only FDA-cleared smartphone app with ECG equivalence.
With FDA clearance, U.S. patients can now access FibriCheck on-demand, with a prescription. The FibriCheck ecosystem consists of a smartphone app for patients, an algorithm based on the latest generation of artificial intelligence (AI) trained on over a million datasets, and a portal for healthcare providers.
Getting FDA clearance for a software application using consumer devices was a difficult challenge, but it demonstrates the skill and excellence of our team. This is just the beginning. Our success serves as a foundation for future growth as we continue to expand our capabilities based on our advancements in AI. We are committed to reshaping the paradigm of monitoring and managing heart rhythm disorders by paving the way for a healthier future, providing the right diagnosis to the right person at the right time. Together, we dream of creating solutions that are not dependent on specific hardware or devices, so that digital health can truly deliver on its promise.
Lars Grieten
CEO and Co-Founder of FibriCheck
FibriCheck transforms consumer devices such as smartphones into medical devices capable of detecting atrial fibrillation and other arrhythmias, without logistical hassles or additional hardware. FibriCheck’s intermittent and remote photoplethysmography (PPG) measurement data is analyzed by FibriCheck’s AI algorithm, which is then shared with FibriCheck’s medical portal, where healthcare providers can gain insight into their patients’ measurement results. Staff can gain insights into their patients’ heart rate, heart rhythm, and AF phenotype, including AF burden, symptoms, symptom severity, and symptom-rhythm correlation. Their patented technology has also demonstrated equal performance across different comorbidities and skin tones.
Over the past year, several algorithm updates have brought substantial improvements to FibriCheck. Independent external validation studies have shown that FibriCheck’s accuracy in detecting AF is excellent, with a sensitivity of 98.3% and a specificity of 99.9%These significant performance gains and improved capabilities have led to another significant achievement, as FibriCheck outperforms leading competing devices for heart rhythm monitoringsuch as the Apple Watch ECG and the KardiaMobile 6-lead wearable ECG.
With over 1 million users, FibriCheck has been implemented in over 20 different clinical pathways in many hospitals across Europe, the UK, Australia and the Middle East, supporting healthcare providers in their clinical decision-making. It has proven clinically superior to traditional care pathways, demonstrating that it is a user-friendly and scalable digital solution that can reduce waiting lists, reduce costs and improve efficiency for both healthcare providers and patients.
Since early 2024, FibriCheck has strengthened its presence in the United States by opening an office in New York, participating in the world-renowned MedTech Innovator and collaborating with European and American hospitals such as Northwestern Medicine Chicago, New York Presbyterian, University of Oklahoma College of Medicine, East-Limburg Hospital and University Hospital Antwerp.
FibriCheck is a graduate of the DigitalHealthLondon Accelerator program.
THE DigitalHealth.London Accelerator The programme is funded by the UK Government through the UK Shared Prosperity Fund (UKSPF). It is delivered by the Health Innovation Network (HIN) South London in partnership with the Office of Life Sciences, CW+, Medicity, NHS England and the Mayor of London.
For more information, please visit https://www.gov.uk/government/publications/uk-
Shared Prosperity Fund prospectus.
