Cardio-HART
AI-powered cardiac diagnostic system delivering echo-level insights at ECG speed in primary care
Company profile
Company profile
Cardio-Phoenix has developed Cardio-HART, a clinically validated AI-powered cardiac diagnostic system that transforms point-of-care cardiac assessment in primary care. The system builds on standard 12-lead ECG functionality by adding structural and functional cardiac insights traditionally only available through echocardiography in secondary care settings. Cardio-HART uses synchronized electrical, acoustic, and mechanical biosignal sensing combined with AI models to detect electrical abnormalities, structural heart disease, valvular pathology (aortic stenosis, mitral regurgitation), and all three heart failure phenotypes (HFpEF, HFmrEF, HFrEF) during a single 10-minute examination. The system provides quantified left ventricular ejection fraction (LVEF) with severity grading, achieving over 90% agreement with echocardiographic measurements. Validated across 15,000+ patients in 14 European centers, Cardio-HART demonstrates 91.2% sensitivity and 88.6% specificity for heart failure detection, reduces inconclusive ECG results by 94%, and increases confirmed diagnoses by 160% compared to standard ECG alone. The technology enables general practitioners and primary care clinicians to make more confident referral decisions, reducing unnecessary echocardiography referrals by up to 66% while identifying high-priority patients who require specialist assessment. Cardio-HART functions as both a triage and diagnostic support tool, bridging the diagnostic gap between ECG screening and echocardiography, ultimately enabling earlier clinical decision-making before symptoms escalate.
Company description Cardio-Phoenix official website
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01 · Operating footprint
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Company milestones
Real-world nurse-led screening pilot in Spain (2025) with 47 tests in 5 hours detecting 3 early-HF cases. Multi-center post-market study completed (2023) with 15,000+ patients. Clinical validation published in European Heart Journal - Digital Health (2024).
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02 · Flagship portfolio
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AI-powered cardiac diagnostic system delivering echo-level insights at ECG speed in primary care
03 · Research intelligence
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Research
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Clinical validation
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Regulatory
K182790 · 510k · Dec 14, 2018
04 · Company-reported outcomes
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31% to 1.9% inconclusive rate vs standard ECG
10% to 26% diagnostic yield in primary care
All HF phenotypes combined
Correlation r=0.78, RMSE ≈8%
Through improved point-of-care triage
Compared to 50% false-positive rate for NT-proBNP
Multi-disease screening
Nurse-led community cardiac screening for early heart failure detection
47 tests completed in 5 hours with 10-minute turnaround; detected 3 asymptomatic heart failure cases
Clinical validation of AI-powered cardiac diagnostics across diverse patient populations
96% agreement with echocardiography; 94% reduction in inconclusive ECGs (31% to 1.9%); 160% increase in confirmed GP diagnoses (10% to 26%)
Primary care heart failure pathway optimization and reduction of unnecessary echocardiography referrals
35-40% reduction in unnecessary echocardiography referrals
Replacement of standard ECG with Cardio-HART for improved cardiac diagnostics in cardiology practice
High diagnostic confidence with echo confirmation of Cardio-HART findings; potential to reduce unnecessary echos and accelerate patient answers at NHS scale
05 · Leadership
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Marc Bisnaire
CEO & Founder
Dr Teresa Castiello
Clinical Advisor (Cardiology President of Royal Society of Medicine)
06 · Company updates
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07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
Companies applying AI to cardiovascular disease detection, ECG/EKG analysis, heart failure management, cardiac imaging, arrhythmia detection, or cardiovascular risk assessment. Includes AI-powered cardiac diagnostics, non-invasive hemodynamic monitoring, and tools for early detection and personalized management of heart conditions.
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