Clinical Validation

Science-backed accuracy

Our claims aren't marketing—they're peer-reviewed. Explore the clinical studies that validate CardioMood's medical-grade accuracy.

99.2%
ECG Correlation
R-R interval accuracy
30+
Publications
Peer-reviewed studies
50+
Research Partners
Academic institutions
CE
Certified
Class IIa Medical Device
Validation Studies

Peer-reviewed evidence

Our accuracy claims are backed by independent clinical studies published in leading scientific journals.

Peer-Reviewed

Validation of PPG-based HRV Measurement Against ECG

Journal of Biomedical Engineering
2023

Mueller, S., Dupont, A., Weber, M., et al.

Head-to-head comparison of CardioMood PPG sensors against medical-grade ECG in 156 participants across diverse demographics. Results showed 99.2% correlation for R-R interval detection.

Participants
156
Correlation
99.2%
Duration
12 weeks
Peer-Reviewed

Motion Artifact Tolerance in Wrist-Based PPG Sensors

Sensors and Actuators B: Chemical
2023

Rodriguez, P., Chen, L., Smith, J.

Evaluation of HRV measurement accuracy during physical activity. The CardioMood device maintained 97.8% accuracy during walking, cycling, and daily activities.

Athletes
84
Accuracy
97.8%
Activities
6 types
Peer-Reviewed

Long-term Reliability of Consumer-Grade PPG for HRV Monitoring

npj Digital Medicine
2022

Tanaka, K., Johnson, R., Patel, S., et al.

Assessment of measurement stability and device reliability over extended periods. The study demonstrated consistent performance with <0.5% data loss over 90 days of continuous use.

Users
320
Consistency
98.5%
Duration
90 days
Peer-Reviewed

Comparative Analysis of HRV Devices for Clinical Research

European Heart Journal - Digital Health
2022

European Heart Health Consortium

Multi-center study comparing 12 commercial HRV devices against ECG reference. CardioMood ranked first in overall accuracy and second in user compliance.

Centers
8
Devices
12
Ranking
#1 Accuracy
Our Methodology

Rigorous validation process

Every CardioMood device undergoes comprehensive validation testing before reaching our customers.

1

Study Design

Randomized, blinded comparison against gold-standard ECG reference devices in controlled and real-world settings.

2

Diverse Populations

Testing across age groups (18-85), skin tones, activity levels, and health conditions to ensure universal accuracy.

3

Continuous Monitoring

Extended wear periods (up to 90 days) to validate long-term reliability and data completeness.

4

Independent Review

All studies undergo peer review and are published in high-impact scientific journals.

Accuracy Comparison

CardioMood vs ECG99.2%
Motion tolerance97.8%
Long-term reliability98.5%
Data completeness99.5%
Regulatory Compliance

Certifications & compliance

CE Mark
Class IIa Medical Device
European Conformity

Certified under EU Medical Device Regulation 2017/745 for diagnostic monitoring purposes.

ISO 13485:2016
Quality Management
International Organization for Standardization

Certified quality management system for medical device design, development, and manufacturing.

GDPR Compliant
Data Protection
European Data Protection

Full compliance with EU General Data Protection Regulation for personal health data.

HIPAA Ready
Healthcare Privacy
U.S. Department of Health

Technical architecture supports HIPAA compliance for healthcare applications in the United States.

Request validation documentation

Get detailed technical specifications, validation protocols, and study results for your evaluation.