FibriCheck Gains FDA Clearance for Launch in the US

FibriCheck, a DigitalHealth.London Accelerator alumnus company, announce their Food and Drug Administration (FDA) clearance and the commercial launch of their technology within the US. Their medically certified technology utilises consumer devices and redefines how cardiac arrhythmias are detected and managed.

After a rigorous investigation procedure by the Food and Drug Administration (FDA), FibriCheck is now FDA-cleared (K232804). With 99% accuracy compared to gold-standard electrocardiogram (ECG) in a recent clinical trial (NCT06282380), FibriCheck was FDA-cleared specifically within the category of smartphone ECG devices, namely the DXH category. FibriCheck is now the only smartphone application that is FDA-cleared with equivalence to ECG.

With the FDA clearance, US 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 artificial intelligence (AI) trained on more than a million datasets, as well as a healthcare provider portal.

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.

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 challenges or additional hardware. The data from FibriCheck’s intermittent and remote photoplethysmography (PPG) measurements is analysed by FibriCheck’s AI algorithm, which is then shared with FibriCheck’s physician portal, where healthcare providers can get an overview of their patients’ measurement results. Staff can gain insights into their patient’s heart rate, heart rhythm and AF phenotype, including AF load, symptoms, symptom severity and symptom-rhythm correlation. Their patented technology has also demonstrated an equal performance across different comorbidities and skin tones.

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%. These significant performance gains and improved capabilities led to another meaningful achievement, as FibriCheck outperformed rivalling state-of-the-art devices for heart rhythm monitoring, such as the Apple Watch ECG and the KardiaMobile 6-lead handheld ECG.

With over one million users, FibriCheck has been implemented in over 20 different clinical pathways throughout numerous hospitals all over 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 how it is a user-friendly and scalable digital solution that can decrease wait lists, reduce costs and improve efficiency for both healthcare providers and patients.

Since the beginning of 2024, FibriCheck has increased its presence in the US by opening a New York office, participating in the world-renowned MedTech Innovator and collaborating with European and US hospitals such as Northwestern Medicine Chicago, the New York Presbyterian, the University of Oklahoma College of Medicine, Hospital East-Limburg and Antwerp University Hospital.

FibriCheck is an alumnus company of the DigitalHealthLondon Accelerator programme.

The DigitalHealth.London Accelerator programme is funded by the UK Government via 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.