Our biomarkers

Novel digital biomarkers for cardiovascular care.

Digital biomarkers built on Prolaio’s continuous, multi-modal data. Some are FDA-cleared; others are clinically validated — together surfacing fit-for-purpose evidence across heart failure, cardiomyopathy, and beyond.

Spotlight case study

Digital Biomarker

eVO2peak

CPET-level cardiopulmonary insight without the stress test. A continuous, FDA-cleared estimate of peak oxygen uptake derived from ECG and vital-sign dynamics during activities of daily living.

FDA Cleared
Heart Failure
HCM
CAD
COPD
Fitness assessment

262

Validation cohort
K252204

FDA 510(k)

Learn more

Scatter plot validating estimated peak VO2 against gold-standard CPET, with points clustering along the line of unity

Biomarker library

Search biomarkers

AllFDA ClearedValidated

Showing 12 of 12

eVO2peak

CPET-level cardiopulmonary insight without the stress test — a continuous, FDA-cleared estimate of peak oxygen uptake derived from ECG and vital-sign dynamics during activities of daily living.
- CAD
- COPD
- Functional capacity
- HCM
- HF
FDA Cleared Status
Multivariate Change Index

Composite signal that flags meaningful physiologic change across multiple vitals at once, surfacing decompensation days earlier than any single biomarker.
- Aortic Stenosis
- CAD
- HCM
- HF
- PAH
Case study coming soon

FDA Cleared Status
AFib Burden

Continuous quantification of atrial fibrillation episodes and time spent in AFib, enabling stroke-risk stratification and treatment-response tracking.
- Atrial Fibrillation
- HF
- Stroke Risk
Case study coming soon

FDA Cleared Status
Heart Rate

Continuous, ECG-validated heart-rate measurement across rest, activity, and sleep for safety monitoring in cardiovascular outcome trials.
- CVOTs
- Multi-indication
- Safety monitoring
Case study coming soon

FDA Cleared Status
QRS Complex

Beat-level ECG morphology characterization for arrhythmia detection, conduction-abnormality screening, and drug-effect monitoring.
- Arrhythmia detection
- Cardiac conduction
- CVOTs
- HF
Case study coming soon

FDA Cleared Status
Respiration Rate

Continuous respiratory-rate measurement derived from ECG and patch dynamics, used across HF, PAH, COPD, sepsis, and sleep-stage analysis.
- COPD
- HF
- PAH
- Sepsis
- Sleep disorders
Case study coming soon

FDA Cleared Status
Heart Rate Variability

Beat-to-beat HRV measurement that captures autonomic-function shifts in heart failure, diabetes, and stress states.
- Autonomic function
- Diabetes
- HF
- Stress
Case study coming soon

FDA Cleared Status
Blood Pressure

Continuous blood-pressure tracking integrated with paired wearable signals for hypertension, HF, CAD, CKD, and CVOT safety monitoring.
- CAD
- CKD
- CVOTs
- HF
- Hypertension
Case study coming soon

FDA Cleared Status
Asleep Probability*

Per-minute probabilistic sleep-state estimate used to derive sleep duration, quality, circadian rhythm, and HF/stress correlates.
- Circadian rhythm
- HF
- Sleep quality
- Stress
Case study coming soon

Validated Status
Steps*

Continuous step count from wearable accelerometry, used to quantify mobility and functional capacity in COPD, HF, and CVOTs.
- COPD
- CVOTs
- Functional capacity
- Mobility
Case study coming soon

Validated Status
Gross Activity*

Aggregate daily physical-activity load from accelerometry, used as a recovery proxy and CVOT secondary endpoint.
- CVOTs
- Physical activity
- Recovery
Case study coming soon

Validated Status
Weight*

Connected-scale weight trends with HF-decompensation alerting, used in fluid-retention management, obesity studies, and CVOTs.
- CVOTs
- Fluid retention
- HF
- Obesity
Case study coming soon

Validated Status

*Validated: This algorithm is generally accepted by the FDA, but does not require clearance.

Novel digital biomarkers for cardiovascular care.

eVO2peak

Want to validate a new endpoint?