Cardiology
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Anumana, Inc.
FDA
FDA-cleared AI medical device
Software-as-a-medical-device algorithm that analyzes standard 12-lead electrocardiograms to detect signals associated with pulmonary hypertension, intended to aid clinicians in identifying patients who may warrant further diagnostic evaluation.
FDA Submission Metadata
- Submission number
- K252360
- Decision date
- March 2026
- FDA panel
- Cardiovascular
- Product code
- SAT
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA