Cardiology
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Anumana, 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
- K252360
- Decision date
- March 2026
- FDA panel
- Cardiovascular
- Product code
- SAT
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.
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