FDA
Breakthrough Device Designation
- Granted March 2026
Clinically adopted smartwatches (this filters the non-fda cleared watches and tells FDA we dont aprove ALL DEVICES) , and only Apple and Samsung of the world
Echocardiographic data for structural and functional assessment
Noninvasive blood pressure measurement in-office or at-home
Patient-specific AI model generated for hemodynamics estimation
Physics-based modeling combined with machine learning creates a patient-specific digital twin that estimates hemodynamic parameters with catheter-level accuracy, all from non-invasive wearable signals.
Clinically adopted smartwatches (this filters the non-fda cleared watches and tells FDA we dont aprove ALL DEVICES) , and only Apple and Samsung of the world
Echocardiographic data for structural and functional assessment
Longitudinal trend analysis for better care decisions
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
