Breakthrough Device Designation

FDA
Breakthrough Device Designation

Granted March 2026

FDA
Breakthrough Device Designation

Granted March 2026

Breakthrough Device Designation

FDA

Breakthrough Device Designation

Granted

March 2026

Learn more

How Coredio Works

A one time personalization, then on demand hemodynamic spot-checks from a smartwatch and BP cuff

The Process

How Coredio Works
1

Patient Onboarding

Patient enrollment with baseline health history, device assignment, and initial clinical assessment.

Patient consent and enrollment

Wearable device pairing

Initial health assessment

2

One-Time Calibration

A short clinical session using PPG, ECG, and EHR data, and blood pressure to personalize the patient's cardiovascular digital twin.

Multi-signal capture

Auto-extracts patient history

Patient-specific baseline creation

3

Extract wearable data

Patients use their smartwatch and blood pressure cuff, at home or upon clinic visit, to capture cardiovascular signals as directed.

Captures wearable sensor data

Blood pressure measurements

Flexible home or clinic use

4

Physics-based AI Analysis

Advanced algorithms combine physics-based modeling with AI to estimate hemodynamic parameters from collected signals.

Signal processing

Physics-informed AI modeling

Hemodynamic parameter estimation

5

Clinician Alerts and Action

Care teams review trends, respond to alerts, and make informed decisions based on continuous cardiovascular insights.

Interoperable Clinician Dashboard

Alerts when matters

Early and proactive intervention

Frequently Asked Questions

No. Coredio works with a consumer smartwatch you wear on your wrist no implants, no needles. Our AI and physics based algorithms are designed to extract deep cardiac insights from your existing wearables, giving your care team a clearer picture of your heart health from home.

Every heart is different. Coredio is designed to track your individual cardiac trends over time and surface them to your clinician  so your treatment plan adapts to you, not a generic protocol. The goal: earlier, smarter interventions before a small change becomes a big problem.

Upon Coredio officially launches, you will work with your care team to identify if your smartwatch is compatible, and you will receive a standard blood pressure cuff. That’s it. No specialized medical equipment, no complicated setup. If you don’t own a compatible watch yet, your care team can help you get one.

Both sides of the care relationship. Cardiologists, primary care physicians, Nurses and rest of the care team use Coredio’s dashboard to remotely spot check heart failure patients and catch concerning trends early. Patients use a smartwatch and our app to stay connected to their care team from home. Caregivers and family members often help with initial setup and patient adherence.

Connect
with Coredio Team!

Join the clinicians who are exploring the future of cardiovascular monitoring

FDA

Disclaimer: Coredio CPSE™ has received FDA Breakthrough Device Designation. The device is not yet cleared by the FDA for commercial use. Indications for Use are subject to FDA review under the 510(k) process.