FDA
Breakthrough Device Designation
- Granted March 2026
Current cardiac monitoring is fragmented, slow, and invasive.
Clinicians use 5+ platforms to view patient data
Catheterization is the gold standard but carries high costs ($5k-$10k)
Stable patients require expensive, frequent in-hospital echocardiograms.
Clinicians use 5+ platforms to view patient data
Clinicians use 5+ platforms to view patient data
Clinicians use 5+ platforms to view patient data
Clinicians use 5+ platforms to view patient data
Clinicians use 5+ platforms to view patient data
Clinicians use 5+ platforms to view patient data
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
A revolutionary approach that doesn’t sacrifice on accuracy and complements care where invasive devices are not accessible
Tested at partner hospitals
Rigorously validated against RHC/LHC and echo in ongoing clinical studies
Studies ongoing at multiple sites
Clear FDA pathway. Engaged with FDA through the Breakthrough Devices Program and TAP Sprint Discussions
Kicked-off 4 internal review board (IRB) approved studies.
Readmission impact to be evaluated in future studies. Invasive hemodynamic monitors have demonstrated significant readmission reduction in randomized trials (e.g., CHAMPION). CoreDio is in active clinical evaluation to assess analogous benefits.
in multiple hospitals against catheterization
Projected 6-10X ROI
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
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
