CE-MDR Medical DevicePeer-Reviewed Studies

Clinical Validation

CardioMood is powered by Corsano Health's CE-MDR certified medical device. Every vital parameter is clinically validated against gold-standard references, bringing medical-grade accuracy to lifestyle and wellness applications.

Medical-Grade Technology

A Certified Medical Device for Everyday Wellness

Our technology partner Corsano Health manufactures CE-MDR certified medical devices validated in clinical studies at leading research institutions. CardioMood leverages this medical-grade hardware to deliver clinical-level accuracy for lifestyle, wellness, and preventive health applications.

CE-MDR
European Medical Device Regulation
ISO 80601
Medical Electrical Equipment
ISO 81060
Blood Pressure Monitoring
IEC 60601
ECG Equipment Standards

Validated Vital Parameters

Each parameter is validated against gold-standard clinical references in controlled studies. Click to view detailed validation data.

99.2%
correlation

Heart Rate & PPG

Beat-to-beat heart rate detection validated against 12-lead ECG in 180 cardiac patients.

R=0.991
Correlation
±3.8 bpm
Bland-Altman
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98.8%
correlation

Oxygen Saturation (SpO2)

Continuous SpO2 monitoring validated against CO-oximetry in induced hypoxia studies.

2.34-3.06 Arms
Accuracy
94,572
Samples
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<5 mmHg
accuracy

Cuffless Blood Pressure

Non-invasive continuous blood pressure monitoring validated per ISO 81060-2:2019.

±2 mmHg
Bias
97
Subjects
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<2 Arms
accuracy

Respiration Rate

Respiratory rate detection validated across multiple body positions.

0.03 brpm
Bias
6-60 brpm
Range
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±0.3°C
accuracy

Body Temperature

Skin and core body temperature monitoring validated against electronic pill reference.

0.14°C
CBT Bias
34-42°C
Range
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256 Hz
sampling

Electrocardiography (ECG)

Single-lead ECG validated per EN-IEC 60601-2-47:2015 standards.

1-lead
Leads
IEC 60601
Standard
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Research Partners

Validated at Leading Institutions

Clinical validation studies conducted by Corsano Health in partnership with renowned research centers across Europe.

Corsano Health
Amsterdam UMC
Basel University Hospital
CMC Europe

Medical-Grade Accuracy for Your Use Case

Whether you're a health coach, corporate wellness program, or research institution, CardioMood uses Corsano Health's CE-MDR certified wearables to deliver clinical-level accuracy in an accessible platform designed for lifestyle applications.