Regulatory & Clinical Notice

Medical & Regulatory Disclaimer

Clinical Decision Support (CDS) System Guidelines • Coeur.AI

Important Clinical Notice:Coeur.AI is designed as an assistive screening and decision support tool for healthcare professionals. It does not replace a comprehensive medical history, physical auscultation by an experienced physician, diagnostic echocardiography, or 12-lead electrocardiograms (ECG).

1. Intended Use & User Qualifications

Coeur.AI is intended for use by trained healthcare professionals (including general practitioners, cardiologists, pulmonologists, nurses, and certified community health workers) as an aid in capturing, visualizing, and analyzing phonocardiogram (PCG) acoustic data.

2. Nature of Algorithmic Findings

All confidence metrics, anomaly flags (e.g. murmur presence, arrhythmia indicators, COPD/wheeze patterns), and generated PDF summaries are preliminary diagnostic insights. They must be evaluated in the context of the patient’s overall clinical presentation, vital signs, and diagnostic laboratory findings.

3. Not for Emergency Diagnostics

Coeur.AI is not intended for acute emergency telemetry or continuous life-critical patient monitoring (e.g., intensive care resuscitation or real-time defibrillator triggering). In cases of acute chest pain, dyspnea, or suspected myocardial infarction, immediate emergency clinical protocols must be initiated.

4. Patient Notice

If you are a patient or non-clinician using Coeur.AI, you must never modify, withhold, or discontinue prescribed cardiac or respiratory medications based solely on application findings without consulting your licensed primary care physician.