FDA
Breakthrough Device Designation
GrantedMarch 2026
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Clinical Evidence

Coredio is being validated against right and left heart catheterization, with positive early results.

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Coredio

Ongoing Validation

Under active clinical evaluation for reliability and real-world use.

Hospital Partnerships

Co-designed with cardiologists to fit real-world workflows.

Physiologically Sound

Grounded in cardiovascular physiology, not pattern-matching alone.

Coredio vs. Traditional Assessment

Comparison

Invasiveness

Traditional Invasive

Catheter insertion required

Coredio Approach

Completely noninvasive

Comparison

Frequency of Use

Traditional Invasive

Limited by procedure burden

Coredio Approach

On-demand spot-checks

Comparison

Patient Burden

Traditional Invasive

Hospital visit, recovery time

Coredio Approach

Simple home-based measurements

Comparison

Outside Hospital

Traditional Invasive

Not feasible

Coredio Approach

Designed for use in clinic and at home

Comparison

Continuity

Traditional Invasive

Episodic snapshots

Coredio Approach

Ongoing cardiovascular visibility

Comparison

Monitoring Cadence

Traditional Invasive

Limited to procedure timing

Coredio Approach

On-demand spot-checks, as directed by the care team

Frequently Asked Questions

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

Initial personalization is performed by a clinician before the patient is discharged. System calibration is performed once during initial setup, and the system may recommend recalibration if significant clinical changes occur.

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.

Clinicians managing heart failure patients, and the patients themselves who benefit from at-home hemodynamic monitoring.

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with the Coredio team

Join the clinicians who are exploring the future of cardiovascular monitoring

Device cluster