FibriCheck

by Qompium nv  · Based in Belgium → — Redefining the way cardiac care is delivered.
Cardiology Family Medicine Internal Medicine
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Available via subscription for end-users (monthly/yearly) or through licensing agreements for healthcare providers and clinical centers.
Regulatory Status Disclosed

Overview

FibriCheck is a medically certified digital health solution developed by Qompium nv, designed to detect and monitor cardiac arrhythmias, including Atrial Fibrillation (AFib), using photoplethysmography (PPG) technology via a smartphone camera. The FibriCheck ecosystem comprises a patient-facing mobile application, an extensively validated AI-powered algorithm for analysis, and a dedicated portal for healthcare professionals. This integrated approach provides actionable insights for clinical decision-making, streamlines workflows, and supports remote patient monitoring. It allows patients to take 60-second measurements of their heart rhythm and rate, log blood pressure and weight, and receive immediate, actionable results that can be easily shared with their physicians. The platform is designed to enhance efficiency, improve diagnostic accuracy, and empower patients in managing their cardiovascular health.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Smartphone camera-based PPG technology for heart rhythm measurement
  • AI-powered algorithm for arrhythmia detection and analysis
  • Healthcare professional portal/dashboard for patient monitoring
  • Patient-facing mobile application
  • Detection of Atrial Fibrillation (AFib) and other arrhythmias
  • Immediate and actionable results
  • Ability to log blood pressure and weight
  • Customizable monitoring rules for healthcare providers
  • Automated reports and insights
  • Medical expert review for anomalous measurements (optional/premium)

Use Cases

  • Early detection of Atrial Fibrillation (AFib)
  • Remote monitoring of cardiac patients
  • Post-intervention follow-up (e.g., after ablation, cardioversion)
  • Outpatient AF management
  • Pre-screening high-risk patients
  • Supporting clinical decision-making

What Physicians Need to Know

Arrhythmia Detection Accuracy
FibriCheck is clinically validated and FDA-cleared for the detection of heart arrhythmias, particularly Atrial Fibrillation (AF), with a reported accuracy of 98.5%. It demonstrates a sensitivity of 96.3% (95% CI: 94.4-97.7%) and a specificity of 99.3% (95% CI: 98.8-99.7%) for AF detection. The algorithm can distinguish between regular rhythm, unclassified rhythm, and possible AF. Its performance remains consistent across various smartphone devices and in patients with comorbidities such as heart failure, vascular disease, hypertension, diabetes, or stroke. However, sensitivity may be reduced in individuals with darker skin tones and higher BMIs, which can be addressed through technician verification.
Heart Failure Risk Prediction
While FibriCheck allows for manual input and storage of systolic and diastolic blood pressure, weight, and height (for BMI calculation), classified according to the 2018 ESC/ESH Guidelines for the Management of Arterial Hypertension, the mobile application itself does not perform further detection or analysis for heart failure risk prediction based on these values. However, by enabling early detection of undiagnosed AF, it can indirectly contribute to mitigating the risk of AF progressing to stroke or heart failure.
Cardiac Monitoring Integration
FibriCheck offers API-based integration into existing Electronic Health Records (EHRs), Remote Patient Monitoring (RPM) platforms, and population health systems, designed to complement existing care ecosystems. It includes a provider portal for reviewing patient data, managing alerts, and accessing clinical insights. FibriCheck has integrated with RPM providers like Smart Meter to deliver heart rhythm data within healthcare providers' workflows.
Real-Time Alert Capability
FibriCheck provides immediate results after each measurement. The provider portal enables healthcare professionals to review patient data and manage alerts, offering timely and actionable insights. Patients receive a detailed report with advice, and irregular measurements can be reviewed by a team of medical experts.
Physician Tip

FibriCheck is a valuable tool for the early detection and ongoing remote monitoring of atrial fibrillation, particularly for patients with suspected arrhythmias, those experiencing palpitations, or post-procedure. Its high accuracy and FDA-clearance provide confidence in its diagnostic capabilities for AF. Physicians can leverage its remote monitoring features to gather longitudinal data, potentially reducing the need for frequent in-person visits and supporting more informed clinical decision-making. While the app provides immediate insights, all interpretations should be reviewed by a medical professional for definitive clinical decisions. Be mindful of potential reduced sensitivity in patients with darker skin tones and higher BMIs, and consider technician verification in such cases.

FibriCheck is designed for seamless integration into existing healthcare ecosystems. It offers API-based integration with Electronic Health Records (EHRs), Remote Patient Monitoring (RPM) platforms, and population health management systems. This allows for efficient data flow and incorporation of heart rhythm data into current clinical workflows. The platform supports customizable API endpoints for tailored functionality, including compatibility with standards like HL7/FHIR. FibriCheck has a proven track record of integration with numerous healthcare systems and RPM providers, facilitating scalable deployment and enhanced patient management.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Available via subscription for end-users (monthly/yearly) or through licensing agreements for healthcare providers and clinical centers.
  • Essential €6.99/month; Premium €24.99/month (yearly subscriptions offer 40% savings); Optional medical expert review for anomalous measurements at €9.99/measurement
  • For patients prescribed by a doctor: €10 for 7 days; €15 for 14 days; €25 for 30 days
DeploymentCloud-based digital application
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

FibriCheck is FDA-cleared (K232804) as a smartphone application with ECG equivalence for heart rhythm monitoring. This clearance covers its entire ecosystem, including the patient-facing app, AI-powered algorithm, and healthcare provider portal, for detecting and monitoring arrhythmias, including AF, using PPG technology.
Integrations
EHR Not specified
Specialties Cardiology, Family Medicine, Internal Medicine

What the Web Says

FibriCheck is a mobile application designed for the detection of atrial fibrillation (AFib) and other heart rhythm disorders using a smartphone's camera. Reviews indicate it's a user-friendly tool for remote monitoring, often praised for its convenience and the ability to share data with healthcare professionals. While generally well-received for its accessibility, some discussions touch upon the need for clear interpretation of results and its role as a screening tool versus a definitive diagnostic device.

Overall: Positive

Strengths

  • Convenient and accessible remote monitoring from a smartphone
  • User-friendly interface and easy to perform measurements
  • Provides detailed reports that can be shared with physicians
  • Can help in early detection of AFib, potentially preventing strokes
  • CE medical device certified and FDA cleared, indicating regulatory approval
  • Offers peace of mind for individuals concerned about heart health

Limitations

  • Requires consistent user engagement for effective monitoring
  • Potential for user misinterpretation of results without medical guidance
  • Not a replacement for professional medical diagnosis or traditional ECGs
  • Accuracy can be affected by user technique or phone model in some cases
  • Subscription model may be a barrier for some users
  • Some users report occasional technical glitches or app crashes

Based on reviews from: Reddit, G2, Capterra, Healthcare IT News, Medical device review sites, Physician forums and discussions

Last updated: 2026-07-20

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Press & Coverage

DigitalHealth.London
FibriCheck Gains FDA Clearance for Launch in the US
FibriCheck, an alumnus of the DigitalHealth.London Accelerator, announced its FDA clearance (K232804) and commercial launch in the US for its medically certified technology that detects and manages cardiac arrhythmias using consumer devices. The smartphone application is now FDA-cleared with 99% accuracy compared to gold-standard ECG in a recent clinical trial, making it the only one of its kind.
2024-07
DAIC
FibriCheck Enters US Market with FDA Clearance
Qompium announced FibriCheck's FDA clearance and commercial launch in the US on July 24, 2024, allowing US patients to access the smartphone application for heart rhythm and heart rate measurements when prescribed by a physician. FibriCheck is the only FDA-cleared smartphone application with ECG equivalence in the U.S., boasting 99% accuracy compared to gold-standard ECG in a recent clinical trial.
2024-07
FibriCheck
FibriCheck is ready to enter the U.S. market with FDA-clearance!
After a rigorous FDA investigation, FibriCheck received FDA clearance (K232804) for its entire ecosystem, including its patient-facing smartphone application, AI-powered algorithm, and healthcare provider portal. This milestone allows FibriCheck to improve US care pathways and provide millions of Americans with easy and accurate heart rhythm measurements using their smartphones.
2024-07
Medical Design and Outsourcing
FibriCheck Gains FDA Clearance for its Heart Rhythm AI Tech
The FDA has cleared FibriCheck's AI-powered algorithm, which transforms a smartphone into a heart rhythm measurement tool, covering the patient-facing app, the algorithm, and the healthcare provider portal. This clearance enables US healthcare providers to implement digital-first solutions and hybrid care models to enhance clinical decision-making.
2024-08
HITLAB
A Customer Journey Analysis of the FibriCheck App and Portal: FDA-Cleared System for Cardiac Rhythm Monitoring
FibriCheck is an FDA-cleared and CE-marked digital health platform that uses smartphone cameras and photoplethysmography (PPG) to detect cardiac rhythm irregularities with over 98% accuracy. The system integrates into clinical workflows to support the detection and management of atrial fibrillation, backed by over 90 peer-reviewed studies.
2025-05
FibriCheck
FibriCheck joins forces with U.K. private healthcare provider Benenden Health
FibriCheck is collaborating with Benenden Health, a UK private healthcare provider, to offer smartphone-based heart rhythm checks to over 870,000 members. This partnership, following a successful pilot where 87% of members expressed interest, aims to support proactive heart health management through digital technology.
2025-05
ResearchGate
FibriCheck Detection Capabilities for Atrial Fibrillation (FDA u2013 AF): A Multicenter Validation Study
This multicenter, multinational study validated FibriCheck's algorithm for detecting atrial fibrillation (AF) using smartphone PPG signals across ten popular smartphone devices. The study, involving 236 patients, demonstrated high overall accuracy (98.5%), sensitivity (96.3%), and specificity (99.3%) for AF detection, supporting its use as a reliable, low-cost tool.
2025-06
FibriCheck
FibriCheck's 2025 wrap-up
FibriCheck's 2025 wrap-up highlights its recognition by the FDA, inclusion on lists of AI-enabled medical devices, and expansion in the U.S. market, including a pilot program with the Midwest Cardiovascular Institute. The company also improved its algorithm, strengthening its 99% accuracy and boosting AF detection by 2.4%.
2025-12

Videos

Product demos, reviews, and walkthroughs for FibriCheck.

View all on YouTube

Frequently Asked Questions

FibriCheck employs photoplethysmography (PPG) technology via a smartphone camera to capture pulse waves. Its proprietary AI algorithm then analyzes these pulse wave patterns to detect irregularities indicative of atrial fibrillation (AFib) and other arrhythmias, providing a rapid assessment. The AI is trained on extensive datasets to identify subtle variations in heart rhythm.
FibriCheck is a CE-marked medical device and holds FDA clearance, indicating its compliance with stringent medical device regulations. Regarding data privacy, it adheres to GDPR and HIPAA standards, ensuring patient data is encrypted, anonymized where appropriate, and securely stored. Data access is strictly controlled and audited.
FibriCheck offers a convenient, on-demand screening tool that patients can use regularly from home, complementing traditional ECGs which provide more detailed diagnostic information. While other wearables exist, FibriCheck is the only FDA-cleared smartphone application using PPG-technology with ECG equivalence, often providing a more accessible and user-friendly interface for guided measurements.
The pricing model for FibriCheck typically involves a subscription fee, which can vary based on the number of patients, duration of monitoring, or integration needs for healthcare providers. For individual patients, it's often available through a prescription model with a monthly or annual subscription, sometimes covered by insurance depending on regional policies.
While highly accurate, FibriCheck's AI algorithm can be affected by poor measurement technique, motion artifacts, or certain underlying conditions that mimic arrhythmias, potentially leading to false positives. Sensitivity can also be reduced in individuals with darker skin tones and higher BMIs, though technician verification can mitigate this. It's designed for screening and monitoring, and any detected irregularities require confirmation with a clinical ECG.
FibriCheck offers integration capabilities with various EHR systems, allowing for seamless transfer of patient data and monitoring reports directly into the patient's medical record. This integration streamlines clinical workflow, reduces manual data entry, and provides physicians with a comprehensive view of a patient's cardiac rhythm history within their existing platform, enhancing efficiency and supporting better clinical decision-making.
FibriCheck provides support for healthcare professionals, including resources on how to use the platform in practice or hospital settings, information on its technology, and guidance on prescribing. The system is designed for efficient onboarding, and support for interpreting results and managing patient data is available to ensure effective integration into clinical workflows.

Compare FibriCheck

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Bunkerhill AVC and FibriCheck are adjacent tools in cardiology AI, both FDA-cleared and HIPAA-compliant, but serve distinct purposes. Bunkerhill AVC focuses on automating the detection and quantification of…
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FibriCheck and Sleepiz One+ are adjacent competitors in the remote patient monitoring space, both offering FDA-cleared, AI-powered tools for vital sign tracking. FibriCheck focuses specifically on heart rhythm…
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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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