FDA

Breakthrough Device Designation

  • Granted March 2026
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The Coredio Platform

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.

Four Essential Pillars

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

Accuracy

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