Cardiology
CorVista System with PH Add-On
Analytics for Life, Inc.
FDA-cleared AI medical device
Pulmonary hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of pulmonary hypertension for further referral or diagnostic follow-up.
FDA Submission Metadata
- Submission number
- K233666
- Decision date
- April 2024
- FDA panel
- Cardiovascular
- Product code
- SAT
- Clinical task (npj)
- diagnosis
- Data modality (npj)
- Signals
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.