FDA

Breakthrough Device Designation

  • Granted March 2026

Catheter-Grade Non Invasive Heart Failure Management

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

FDA

Breakthrough Device Designation

A complete, connected ecosystem

Designed for both clinical rigor and patient simplicity.

The Challenge

Current cardiac monitoring is fragmented, slow, and invasive.

Inefficient Monitoring

BP cuffs and weight scales often provide inaccurate or late indications of heart failure escalation.

Invasive Procedure Burden

Clinicians use 5+ platforms to view patient data

Time-Consuming Monitoring

Clinicians use 5+ platforms to view patient data

Fragmented Data Systems

Clinicians use 5+ platforms to view patient data

Invasive Procedure Burden

Clinicians use 5+ platforms to view patient data

Time-Consuming Monitoring

Clinicians use 5+ platforms to view patient data

Fragmented Data Systems

Clinicians use 5+ platforms to view patient data

Invasive Procedure Burden

Clinicians use 5+ platforms to view patient data

Time-Consuming Monitoring

Clinicians use 5+ platforms to view patient data

The Challenge

Current cardiac monitoring is fragmented, slow, and invasive.

Inefficient Monitoring

Clinicians use 5+ platforms to view patient data

Limited Accessibility

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

Invasive & Costly Care

Stable patients require expensive, frequent in-hospital echocardiograms.

Fragmented Data Systems

Clinicians use 5+ platforms to view patient data

Invasive Procedure Burden

Clinicians use 5+ platforms to view patient data

Time-Consuming Monitoring

Clinicians use 5+ platforms to view patient data

Fragmented Data Systems

Clinicians use 5+ platforms to view patient data

Invasive Procedure Burden

Clinicians use 5+ platforms to view patient data

Time-Consuming Monitoring

Clinicians use 5+ platforms to view patient data

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.