FDA
Breakthrough Device Designation
- Granted March 2026
How Coredio Works
Patient-specific AI models and device-agnostic sensor-fusion, enables early HF escalation alerts and on-demand actionable intracardiac insights
The Complete Process
Five clear steps from onboarding to clinical action
Patient Onboarding
Patient enrollment with baseline health history, device assignment, and initial clinical assessment.
- Patient consent and enrollment
- Wearable device pairing
- Initial health assessment
One-Time Calibration
A 3-minute clinical session using PPG, ECG, ultrasound, and blood pressure to create a personalized digital twin. The care team collects routine baseline measurements using existing non-invasive clinical tools to personalize the patient-specific model.
- Multi-signal capture
- Ultrasound-informed measurements
- Patient-specific baseline creation
Device-Based Data Capture
Patients use their smartwatch and arm cuff at home or clinic for ongoing cardiovascular signal collection.
- Wearable signal monitoring
- Blood pressure measurements
- Flexible home or clinic use
AI Analysis and Estimation
Advanced algorithms combine physics-based modeling with AI to estimate hemodynamic parameters from collected signals.
- Signal processing
- Physics-informed AI modeling
- Hemodynamic parameter estimation
Clinician Review and Action
Care teams review trends, respond to alerts, and make informed decisions based on continuous cardiovascular insights.
- Dashboard monitoring
- Alert-based workflows
- Trend analysis for intervention
The Complete Process
Five clear steps from onboarding to clinical action
One Time Initialization
The foundation of accurate, personalized estimation begins with a comprehensive personalization session with a quick but robust initialization session.
Wearable Signals
Clinically adopted smartwatches (this filters the non-fda cleared watches and tells FDA we dont aprove ALL DEVICES) , and only Apple and Samsung of the world
Other securely-accessed patient data
Echocardiographic data for structural and functional assessment
Blood Pressure Cuff
Noninvasive blood pressure measurement in-office or at-home
Personalization
Patient-specific AI model generated for hemodynamics estimation
One Time Initialization
The foundation of accurate, personalized estimation begins with a comprehensive personalization session with a quick but robust initialization session.
Change to on-demand daily spot check
Flexible monitoring frequency based on clinical needs
Repeated monitoring without invasive procedures
Continuous cardiovascular visibility over time
CPSE powered Hemodynamic monitoring
Advanced algorithms transform wearable signals into clinical insights
Signal Inputs
- Photoplethysmography (PPG)
- Electrocardiogram (ECG)
- Blood Pressure (BP)
- Patient-Specific Calibration Data
Hemodynamic Outputs
Physics-based modeling combined with machine learning creates a patient-specific digital twin that estimates hemodynamic parameters with catheter-level accuracy, all from non-invasive wearable signals.
Clinical Review & Action
Clinicians access comprehensive dashboards to review trends, monitor patients, and take action earlier.
Clearer Monitoring
Clinically adopted smartwatches (this filters the non-fda cleared watches and tells FDA we dont aprove ALL DEVICES) , and only Apple and Samsung of the world
Faster Follow-Up
Echocardiographic data for structural and functional assessment
Continuous Insights
Longitudinal trend analysis for better care decisions
Frequently Asked Questions
Is Coredio invasive?
A revolutionary approach that doesn’t sacrifice on accuracy and complements care where invasive devices are not accessible
Personalization
A revolutionary approach that doesn’t sacrifice on accuracy and complements care where invasive devices are not accessible
What devices are used?
A revolutionary approach that doesn’t sacrifice on accuracy and complements care where invasive devices are not accessible
Who is the platform designed for?
A revolutionary approach that doesn’t sacrifice on accuracy and complements care where invasive devices are not accessible