FDA
Breakthrough Device Designation
- Granted March 2026
Clinical Evidence
Coredio provides non-invasive cardiovascular insights through rigorous clinical validation.
Clinical Validation
Clinicians use 5+ platforms to view patient data
World Class Hospital Collaborations
Catheterization is the gold standard but carries high costs ($5k-$10k)
Cardiovascular Monitoring Utility
Top-physician and hospital execs involved in testing to guarantee robustness of evidence generation.
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
Clinical Validation
Clinicians use 5+ platforms to view patient data
World Class Hospital Collaborations
Catheterization is the gold standard but carries high costs ($5k-$10k)
Cardiovascular Monitoring Utility
Stable patients require expensive, frequent in-hospital echocardiograms.
Validation Metrics
Quantifying clinical efficacy to reduce procedural risks and improve patient safety
Accuracy
Catheter-validated
Sensitivity
Clinical threshold detection for early intervention
Monitoring Relevance
Continuous visibility between clinical visits
Trial Readiness
Ongoing collaboration with research partners
Coredio vs. Traditional Assessment
Comparison
Comparison
Comparison
Invasiveness
Catheter insertion required
Completely non-invasiveCompletely non-invasive
Frequency of Use
Limited by procedure burden
On-demand daily spot checking
Patient Burden
Hospital visit, recovery time
Simple home-based measurements
Outside Hospital
Not feasible
Clinics+home use (both are in our IFU)
Continuity
Episodic snapshots
Daily
Monitoring Support
Limited to procedure timing
Invasiveness
Frequently Asked Questions
Is Coredio invasive?
A revolutionary approach that doesn’t sacrifice on accuracy and complements care where invasive devices are not accessible
Personalization
A revolutionary approach that doesn’t sacrifice on accuracy and complements care where invasive devices are not accessible
What devices are used?
A revolutionary approach that doesn’t sacrifice on accuracy and complements care where invasive devices are not accessible
Who is the platform designed for?
A revolutionary approach that doesn’t sacrifice on accuracy and complements care where invasive devices are not accessible