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Breakthrough Device Designation
GrantedMarch 2026
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Noninvasive hemodynamic insight for heart failure care

Coredio estimates catheter grade intracardiac hemodynamics using wearables, AI, and digital twins

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Patient using Coredio wearable monitoring
Coredio clinical interface
Coredio device

The challenge

Cardiac monitoring today is fragmented, costly, and invasive

Clinician overwhelmed at a monitoring station

Insufficient monitoring

Patients waiting anxiously in a clinic

Limited access between visits

Gloved hands with cash and a syringe

Invasive and costly

The platform solution

Enabling noninvasive, personalized heart monitoring through AI digital twins and wearables.

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Clinician measuring a patient's blood pressure

Patient eligibility

Patient eligibility

The solution

Coredio brings catheter-grade hemodynamics to anywhere

LVDEP

Left Ventricular End-Diastolic Pressure (LVEDP) predicts worsening heart failure before symptoms start.

Our ecosystem

A connected ecosystem designed for clinical rigor and patient simplicity.

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Coredio

Monitoring workflow

A simple workflow, that enables disease management without added complexity

Patient personalization

During routine initial checkups, Coredio automatically builds a personalized patient model in the background.

Home setup

We'll set up your smartwatch and BP cuff for home use and provide a watch if you don't have one.

Remote monitoring

Coredio estimates hemodynamic status from daily smartwatch and blood pressure readings.

Clinical review & reporting

Care teams review patient-specific alerts, and intervene early.

Precision

Coredio’s technology features

Validated Against Catheterization

Spot-Check Hemodynamic Status

Catheter-Grade Estimates

Testimonial

Built for the entire care continuum

Dr. Jagmeet P. Singh, 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, MGH

Mass General Brigham

Validated

Validation in progress against right and left heart catheterization at U.S. partner sites.

Validation at U.S. partner sites
FDA

Frequently asked questions

No. Coredio is entirely noninvasive. It relies on wearable sensors such as a smartwatch and a blood-pressure cuff — there are no implants, catheters, or surgical procedures involved.

Every heart is different. Coredio builds a model from your own baseline measurements, then tracks your individual cardiovascular trends over time and shares them with your clinician. The aim is earlier, smarter intervention before a small change becomes a serious one.

A compatible smartwatch and a blood-pressure cuff. If you don't already have a watch, we'll provide one as part of your home setup.

Coredio is designed for clinicians managing heart-failure patients and for the patients themselves who benefit from at-home hemodynamic monitoring.

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with Coredio team!

Join the clinicians who are exploring the future of cardiovascular monitoring

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