Coredio – Coredio website

FDA

Breakthrough Device Designation

Granted March 2026

Non-Invasive Hemodynamic Insight for Heart Failure Care.

Coredio estimates intra-cardiac metrics using wearables, AI, and digital twins

The Challenge

Current cardiac monitoring is fragmented, slow, and invasive.

Inefficient Monitoring

Clinicians use multiple disconnected platforms

Invasive Procedure Burden

Catheterization is the gold standard but carries high costs ($5k-$10k)

Time-Consuming Monitoring

Stable patients require expensive, frequent in-hospital echocardiograms.

The Platform Solution

A non-invasive, patient-specific approach designed to support hemodynamic assessment and clinician review.

The Solution

Coredio gives the solution to all the problems with typical catheterization

Left Ventricular End-Diastolic Pressure

Left Ventricular End-Diastolic Pressure is a marker of left-sided filling pressure and congestion. Elevated LVEDP may help identify worsening heart failure status before symptoms become obvious.

CI

Cardiac Index reflects cardiac output adjusted for body size and helps assess whether blood flow is sufficient for the body’s needs.

CVP

Central Venous Pressure reflects right-sided filling pressure and venous congestion, providing additional context on volume status and right-heart strain.

SVR

Systemic Vascular Resistance reflects the resistance the heart pumps against. Elevated SVR can increase afterload and contribute to reduced forward flow.

Pulse Transit Time (PTT)

Pulse Transit Time reflects how quickly the pulse wave travels through the arteries and can provide insight into vascular tone and blood pressure-related changes.

A complete, connected ecosystem.

Designed for both clinical rigor and patient simplicity.

Cardiologist approved Heart Failure management metrics

Derived directly from non-invasive watch and cuff inputs using our FDA Grade-A digital twin algorithm.

LVEDP

Left Ventricular End-Diastolic Pressure.

CO

Cardiac Output

SVR

Systemic Vascular Resistance.

CVP

Central Venous Pressure.

Monitoring Workflow

A simple four-step workflow from initial personalization to clinician review.

Patient Personalization

1-time Initialization: At the initial visit, the doctor connects patient to routine checkup tools and uses Coredio's platform to make it patient-specific.

Home Setup

The care team sets up the patient’s smartwatch and compatible blood pressure cuff for home use. A compatible device can be provided if needed.

Remote Monitoring

Patients perform daily spot-checks at home or in clinic using their smartwatch and blood pressure cuff. CoreDio estimates hemodynamic status for clinician review.

Clinical Review & Reporting

Care teams review trends, follow up with patients as needed, and generate summary reports to support documentation and workflow needs.

Catheter-correlated estimation

Non-invasive, model-based estimates designed to support clinician review of LVEDP, CVP, CI, and SVR trends.

Precision

CoreDio’s precision
features:

Coredio’s technology features:

Validated against right- and left-heart catheterization.
On-demand CI/LVEDP/CVP/SVR trends across week days
Catheter-correlated estimation

Accuracy

The Sensitivity Of The Device in Finding Accurate Statistics

Accuracy & Validation

Validation: Tested at partner hospitals
Standard Comparison: Rigorously validated against RHC/LHC and echo in ongoing clinical studies
Patient Trials: Studies ongoing at multiple sites

Future Milestones

Regulatory: Clear FDA pathway. Engaged with FDA through the Breakthrough Devices Program and TAP Sprint Discussions
Expansion: Kicked-off 4 internal review board (IRB) approved studies.

Testimonial

Built for the entire care continuum.

CoreDio’s use of wearable-derived signals and physics-informed AI to estimate hemodynamic status noninvasively has the potential to give clinicians a more continuous view of patient physiology and support earlier intervention in heart failure care.

CoreDio has the potential to bring hemodynamic-level data into the home setting without invasive devices or additional clinical visits, helping clinicians monitor and respond to early decompensation during the critical post-discharge period.

CoreDio’s approach of extracting catheterization-comparable hemodynamic data from consumer wearables using physics-based AI has the potential to improve real-time visibility and support earlier, evidence-based decisions for CHF patients.

CoreDio’s digital twin platform uses wearable-derived data to estimate catheterization-comparable hemodynamic measurements, helping address the monitoring gap between outpatient visits for patients with complex and dynamic heart failure syndromes.

Proven Clinical Outcomes

Empowering Health System Executives (CFOs) with tangible value-based care metrics and massive operational cost reductions.

50%

readmission impact to be evaluated in future studies. Invasive hemodynamic monitors have demonstrated significant readmission reduction in randomized trials (e.g., CHAMPION). CoreDio is in active clinical evaluation to assess analogous benefits.

Validated

in multiple hospitals against catheterization

6-10X

Projected 6-10X ROI