FibriCheck's 2024 wrap-up

FibriCheck entered the U.S. market with FDA-approved heart monitoring technology

2024 was a transformative year for FibriCheck as we achieved FDA clearance (K232804) for our entire ecosystem, including our patient-facing app, AI-powered algorithm, and healthcare provider portal. The FDA-clearance allows us to deliver accurate (96.3% sensitivity, 99.3% specificity) heart rhythm measurements while offering healthcare providers a billable, scalable solution that enhances workflows, patient outcomes and revenue streams.

This milestone marked our official entry into the U.S. market, supported by a new office in New York and collaborations with leading institutions like Northwestern Medicine, the University of Oklahoma College of Medicine and New York Presbyterian. With recognition from prestigious programs such as the MedTech Innovator and the HITLAB Innovator Summit, FibriCheck is poised to revolutionize cardiac care pathways, empowering providers and patients in the U.S. with innovative, accessible heart rhythm monitoring solutions.

Integrations are a centerpiece of our valuable collaborations in 2024

In 2024, FibriCheck expanded its global reach through impactful collaborations. Partnering with Ultrahuman, we integrated our AF detection technology with their wearable Ring AIR, enabling continuous nocturnal monitoring and personalized cardiac care. With patientMpower, we combined FibriCheck’s certified technology with their virtual care platform, empowering remote monitoring for patients with cardiovascular conditions in Ireland.

In South East London, we launched an innovative atrial fibrillation detection initiative with local pharmacies, facilitating early diagnosis and seamless care coordination. We are also proud to look back at our ongoing collaboration with Ziekenhuis Oost-Limburg, where FibriCheck now also became part of a heart failure care pathway, allowing patients to track vital signs and symptoms to provide clinicians with real-time insights that help support their clinical decision making. These collaborations support our mission to transform cardiovascular care and improve patient outcomes worldwide.

Strengthening our collaborations with healthcare insurers

Our collaborations with healthcare insurers are also of high importance to us. They allow us to empower a higher number of people, which leads to earlier detection of abnormalities and improved patient outcomes. Insurers on the other hand can increase member engagement, provide their members with peace of mind, decrease the amount of claims and save costs by adding FibriCheck to their offering.

Over the past year, FibriCheck deepened its partnerships with healthcare insurers to expand the access to heart health solutions. In Belgium, our collaboration with Helan entered its third year. We also renewed our partnership with CM and initiated a new collaboration with VNZ, offering their members reimbursement for the use of FibriCheck to promote early detection and monitoring of heart rhythm conditions. Through these collaborations, more than half of all Belgians can easily access remote heart rhythm monitoring.

Internationally, we joined forces with Zilveren Kruis in the Netherlands, where telemonitoring with FibriCheck is now also reimbursed under NZa code 039133. In Spain, our partnership with Sanitas, part of the Bupa Group, enabled users to monitor their heart health and connect with healthcare providers when necessary. In the U.S., our services are also billable, which underlines the added value of our accurate heart rhythm measurements.

Increased insights through product development

Over the past year, FibriCheck introduced key innovations to enhance remote heart health monitoring, focusing on addressing critical cardiovascular risk factors and improving user and provider experiences. A major milestone was the integration of a weight logging functionality, enabling users to track their weight and calculate their BMI, providing deeper insights into heart health. This addition complements the blood pressure feature launched in 2023, which has seen 100.000 blood pressure measurements logged since its introduction. Both weight and blood pressure significantly impact conditions such as atrial fibrillation (AF) and heart failure. With these functionalities, healthcare providers gain valuable data which they can use to optimize patient care while empowering users to take proactive steps toward improving their cardiovascular health.

Additionally, FibriCheck launched a treatment and diagnostics logging feature, enabling providers to document interventions like ablation and diagnostics such as Holter monitors directly in the portal. This feature allows comparison of patient symptoms, rhythms, AF load and AF severity before and after procedures. With this new feature, healthcare providers can gain comprehensive insights into treatment effectiveness. On the technical side, significant AI algorithm updates improved our diagnostic accuracy and reduced the amount of low quality measurements, saving users approximately 330 hours annually. These product advancements underscore FibriCheck’s commitment to leveraging real-world data and innovative technology to deliver better heart health outcomes.

5 key messages from our clinical studies last year

At FibriCheck, clinical research is the driving force behind everything we do. In 2024, various studies underscored the added value of our technology to gain insights into heart health.

A study by Gruwez et al confirmed that the various updates to our AI-powered algorithm led to a significant improvement in our performance and accuracy, with a sensitivity of 98.3% and a specificity of 99.9% in free-living conditions.
Another independent validation study performed by Wouters et al., concluded that FibriCheck was best in class when compared to rivaling state-of-the-art devices for heart rhythm monitoring, such as the Apple watch ECG and the KardiaMobile 6-lead handheld ECG!
A prospective observational study by Kamsani et al., compared ECG to FibriCheck’s PPG monitoring over 30 days in patients post-cryptogenic stroke. The findings showed that PPG is feasible for AF detection after stroke and that it may offer a cost-effective alternative for rhythm management to prevent secondary strokes.
A study at the Maastricht University Medical Center + concluded that the use of FibriCheck for opportunistic screening within a population suffering from COPD is feasible. This screening is important, as COPD patients are at risk of developing AF and should therefore follow up on their heart rhythm. With this digital approach, the recommended AF screening in COPD populations can be translated into practice in an easy and efficient way using FibriCheck.
A study by Saleh et al. demonstrated the effectiveness of virtual AF wards integrating FibriCheck with electronic health records. Overseen by specialist nurses, the system safely triaged patients, reduced rehospitalization rates, shortened inpatient stays by four days, and lowered costs by up to £990 per patient. The study also reported 95% patient engagement with remote monitoring and positive feedback.

We want to thank the pioneers that carried out these studies! Thanks to your work and efforts, we can continue to improve cardiac care.

There are also several ongoing studies that have recently been started to increase our scientific footprint, such as the VIR-SAAF study, which is a groundbreaking clinical trial exploring whether at-home sleep apnea testing could boost the quality of life for people with AFib. Another one to look forward to is the CRAAFT-HF study, which investigates the potential benefits of ablation procedures for patients with heart failure. As part of the study, FibriCheck will play a key role in collecting real-world data, providing critical insights to evaluate the clinical outcomes. We’re looking forward to the results of these studies in 2025!

We’re looking forward to 2025!

We’re excited to continue supporting our users and healthcare professionals throughout 2025, and are eager to share our developments in the U.S. market with you. Subscribe to our newsletter and follow us on social media to stay up to date with our latest projects and product improvements!