FDA

Breakthrough Device Designation

  • Granted March 2026
Learn More
Contact

Non-Invasive Hemodynamic Insight for Heart Failure Care.

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

Request a Demo

The Challenge

Current cardiac monitoring is fragmented, Slow , and invasive

Insufficient Monitoring

Clinicians use 5+ platforms to view patient data

Limited Accessibility

Stable patients require expensive, frequent in-hospital echocardiograms.

Invasive & Costly Care

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

The Challenge

Current cardiac monitoring is fragmented, Slow , and invasive

Insufficient Monitoring

Clinicians use 5+ platforms to view patient data

Limited Accessibility

Stable patients require expensive, frequent in-hospital echocardiograms.

Invasive & Costly Care

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

The Platform Solution

AI digital twins: Personalizing and enhancing invasive procedures
Learn more
Patient
Eligibility
Quick Personalization
Quick Initialization

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.

Cardiac Index

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

Central Venous Pressure

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

Systemic Vascular Resistance

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

The ecosystem

A complete, connected ecosystem designed for both clinical rigor and patient simplicity
Learn more

Monitoring Workflow

Simplifying the complexities of standard catheterization through smarter monitoring

  1. Patient Personalization

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

  2. 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.

  3. 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.

  4. Clinical Review & Reporting

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

Precision

Coredio’s technology features
Validated Heart Catheterization
Spot Checking Hemodynamic Trends
Catheter-Based Estimation

Estimation

Non-invasive hemodynamic trend estimates.

Accuracy & Validation

Validation and
Test

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

FDA-engaged via Breakthrough & TAP programs.

Expansion

Kicked-off 4 internal review board (IRB) approved studies.

Testimonial

Built for the entire care continuum
Dr. Singh - Electrophysiologist at MGH

“CoreDio’s wearable-derived signals and physics-informed AI could help close the gap between hospital-based measurements and at-home heart failure monitoring, giving clinicians earlier visibility into patient physiology. FDA Breakthrough Device Designation reflects the clinical need this technology addresses.”

Dr. Jagmeet P. Singh Mass General Brigham

“CoreDio could bring hemodynamic-level insight into the vulnerable post-discharge period without invasive devices or extra clinic visits. By using a smartwatch and blood pressure cuff at home, it may help clinicians detect early decompensation and respond sooner.”

Dr. Farrukh Jafri White Plains Hospital

“CoreDio’s ability to estimate catheterization-comparable hemodynamic data from consumer wearables could give clinicians real-time visibility between visits. This may support earlier intervention, stronger evidence-based decisions, and better outcomes for heart failure patients.”

Dr. Jennifer Monti — MaineHealth

“CoreDio’s digital twin approach may help estimate key hemodynamic metrics from wearable devices, including filling pressures, cardiac index, and vascular resistance. Its FDA Breakthrough Device Designation and TAP Pilot acceptance highlight the promise of non-invasive monitoring.”

Dr. Ioannis Mastoris Mass General Brigham

Proven Clinical Outcomes

50%

Clinical studies underway to evaluate readmission reduction impact.

Validated

in multiple hospitals against catheterization

6-10X

Projected 6-10X ROI

Frequently Asked Questions

No. Coredio works with a consumer smartwatch you wear on your wrist — no implants, no needles. Our AI and physics-based algorithms are designed to extract deep cardiac insights from your existing wearables, giving your care team a clearer picture of your heart health from home.

Every heart is different. Coredio is designed to track your individual cardiac trends over time and surface them to your clinician — so your treatment plan adapts to you, not a generic protocol. The goal: earlier, smarter interventions before a small change becomes a big problem.

Upon Coredio officially launches, you will work with your care team to identify if your smartwatch is compatible, and you will receive a standard blood pressure cuff. That’s it. No specialized medical equipment, no complicated setup. If you don’t own a compatible watch yet, your care team can help you get one.

Both sides of the care relationship. Cardiologists, primary care physicians, Nurses and rest of the care team use Coredio’s dashboard to remotely spot-check heart failure patients and catch concerning trends early. Patients use a smartwatch and our app to stay connected to their care team from home. Caregivers and family members often help with initial setup and patient adherence.

Join the clinicians who are exploring the future of cardiovascular monitoring

Connect
with Coredio Team!
Request a Demo
Contact

FDA

Desclaimer: CoreDio CPSE™ has received FDA Breakthrough Device Designation. The device is not yet cleared by the FDA for commercial use. The Indications for Use are subject to FDA review during the 510(k) process.

Contact