FDA
Breakthrough Device Designation
- Granted March 2026
Clinicians use 5+ platforms to view patient data
Catheterization is the gold standard but carries high costs ($5k-$10k)
Top-physician and hospital execs involved in testing to guarantee robustness of evidence generation.
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
Catheter-validated
Clinical threshold detection for early intervention
Continuous visibility between clinical visits
Ongoing collaboration with research partners
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
