FDA

Breakthrough Device Designation

  • Granted March 2026

The Coredio Platform

Save patients, improve quality metrics, while reducing cost of care and hospital burden

Track estimated HF outcome trends to support clinician decision-making

Help identify patients who may need earlier follow-up

Powered by Coredio CPSE (put trademark sign) Cardiac performance simulation engine.

Secure Data Flow

From multiple wearables and clinician web portals, with highest security standards

Physics Based AI

Enables early HF escalation alertsv

EHR Interoperability

Easy integration and smooth workflow

Actionable insight

Hemodynamics data that impacts care

Four Essential Pillars

The Coredio platform is built on a foundation of personalized care, continuous monitoring, and clinical decision support.

CVP

Central Venous Pressure (CVP) measures right heart pressure to track fluid status and volume overload, signaling risks of dysfunction early.

CI

Cardiac Index (CI) measures heart performance relative to body size, helping clinicians detect poor organ perfusion before symptoms appear.

LVEDP

Left Ventricle End Diastolic Pressure (LVEDP) is an early indicator of heart failure congestion, often rising before symptoms appear.

Pulse Transit Time (PTT)

PTT measures how long a pulse wave takes to travel through the arteries. Changes in PTT reflect shifts in blood pressure and vascular tone.

Hemodynamic Estimation

AI-powered analysis of cardiovascular metrics

Clinical Decision Support

Real-time alerts and trend analysis for care teams

Ongoing Monitoring

Continuous data collection from wearable devices

Personalized Calibration

Patient-specific setup for accurate baseline measurements

Watch App

Single-button data collection and transfer

Realtime sync

Full cardiac signal extraction

Simplest patient engagement

Dashboard

See impact of med management

Actionable alerts

All-in one view of patient health

Secure data flow and reports

Mobile App

basic mode operates with 0-1 click

advance user can see details

MD notes and insight

Designed for maximum adherence

Monitoring Workflow

Simplifying the complexities of standard catheterization through smarter monitoring

Remote Monitoring

Track estimated LVEDP, CI, CVP, and SVR trends to support clinician decision-making.

Patient Calibration

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.

Care & Reporting

Communicate with patient and receive a ready to submit report for RPM coding purposes.

Home Setup

Prescribe and instruct patient to use Coredio for home monitoring: Install Coredio on patient wearable and connect to Cuff. If they don't have a compatible wearable, the device can be provided by clinician.

Accuracy

The Sensitivity Of The Device in Finding Accurate Statistics

Heart Failure Spot-Checks

Where it fits:

Tested at partner hospitals

Who use it:

Comparison: Strong correlation with Right and Left Heart Cath and echo

Why it matters:

Trials: Studies ongoing at multiple sites

Cardiology Follow-Up

Where it fits:

Tested at partner hospitals

Who use it:

Comparison: Strong correlation with Right and Left Heart Cath and echo

Why it matters:

Trials: Studies ongoing at multiple sites

Post-Discharge Workflow

Where it fits:

Tested at partner hospitals

Who use it:

Comparison: Strong correlation with Right and Left Heart Cath and echo

Why it matters:

Trials: Studies ongoing at multiple sites

Frequently Asked Questions

A revolutionary approach that doesn’t sacrifice on accuracy and complements care where invasive devices are not accessible

Calibration is performed once during initial setup. The system may recommend recalibration if significant clinical changes occur.

A revolutionary approach that doesn’t sacrifice on accuracy and complements care where invasive devices are not accessible

A revolutionary approach that doesn’t sacrifice on accuracy and complements care where invasive devices are not accessible

Connect with Coredio Team!

Join the clinicians who are exploring the future of cardiovascular monitoring

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.