Pulmonary Hypertension Machine Learning-Based Notification Software
FDA product code SAT · 3 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.2380
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2024-04-05 – 2026-08-21
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.
SAT
2026-08-21
SAT
2026-03-28
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
View details →
SAT
2024-04-05
CorVista System with PH Add-On
View details →No matching devices.
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