1CMR Pro
FDA 510(k) cleared and CE Class IIB cardiac MRI analysis software for enhanced speed, accuracy and precision
Software · Cloud SaaSCompany source
Company profile
About Mycardium AI
MyCardium AI is a medical technology company that combines innovation and expertise to revolutionize cardiac imaging through artificial intelligence. The company develops FDA 510(k) cleared and CE Class IIB certified AI software solutions for cardiac diagnostics, including 1CMR Pro for cardiac MRI analysis and EchoConfidence for echocardiography. Their human-in-the-loop AI technology delivers precision analysis across more than 100 cardiac measures, enhancing speed, accuracy, and diagnostic confidence for clinicians. MyCardium AI specializes in multiple cardiovascular conditions including amyloidosis (ATTR-CM), Fabry's disease, cardiomyopathies (HCM, DCM, ARVC), inflammatory cardiomyopathies, heart failure (HFrEF, HFpEF), myocarditis, aortic stenosis, cardio-oncology, and cell/gene therapies. In addition to their AI software products, the company operates CoreLab services that provide expert imaging analysis by doctors utilizing better-than-human AI software with industry-leading data management to support global clinical trials. Their CoreLab services cover site qualification, imaging documents, quality checks, and analysis for cardiac MRI and echocardiography studies. The company is led by world-leading cardiac imaging experts including Professor James Moon (CEO), Professor Charlotte Manisty (Director and Founder), and Professor Mark Westwood (Director and Founder), with Dr. Rhodri Davies serving as AI Development Lead. MyCardium AI maintains partnerships with major healthcare organizations including Optum and Change Healthcare Enterprise Imaging Healthcare.
Company description Mycardium AI official website
Primary marketCardiology & Cardiovascular Health
Commercial modelCommercial information available on request
Company presenceOfficial website
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01 · Operating footprint
Where the Company operates
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Clinical focus
- Amyloidosis (ATTR-CM)
- Aortic Stenosis
- Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
- Cardio-Oncology conditions
- Dilated Cardiomyopathy (DCM)
- Fabry's disease
- Heart Failure (HFrEF, HFpEF)
- Hypertrophic Cardiomyopathy (HCM)
- Inflammatory Cardiomyopathies
- Myocarditis
Who it serves
- Cardiology Clinics
- Clinical Trial Sponsors
- Health Systems
- Research Institutions
Deployment & integration
Cloud Saas · Hybrid deployment with recorded integration context.
Geographic context
MarketsGlobal (clinical trials support) · United Kingdom · United States
Company sourceOfficial website
Company milestones
Platform expansion
FDA 510(k) clearance and CE Class IIB certification for both 1CMR Pro and EchoConfidence products. NICE Draft Guidance 2026 recognition. CMR London conference reinstatement. Early career award SCMR 2024 London for precision diagnosis research.
Partnerships
Recorded partners
- Change Healthcare Enterprise Imaging Healthcare
- Optum
02 · Flagship portfolio
Products, workflows, and platform capabilities
Selected source-backed Company products and the available commercial context.
CoreLab
Expert cardiac imaging analysis by doctors utilizing AI software for global clinical trials
Service · HybridCompany source
EchoConfidence
FDA 510(k) cleared and CE Class IIB AI-powered echocardiography analysis across 100+ measures
Software · Cloud SaaSCompany source
03 · Research intelligence
Research Intelligence evidence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Evidence position
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Publications & preprints
Correction: Distinct circle of willis anatomical configurations in healthy preterm born adults: a 3D time-of-flight magnetic resonance angiography study.BMC medical imaging · Feb 17, 2025
Distinct Circle of Willis anatomical configurations in healthy preterm born adults: a 3D time-of-flight magnetic resonance angiography study.BMC medical imaging · Jan 30, 2025
Clinical validation
Clinical-trial records
No linked records are currently available.
Regulatory
Regulatory records
EchoConfidence (USA)K250670 · 510k · Jun 30, 2025
1CMR ProK242062 · 510k · Nov 15, 2024
04 · Company-reported outcomes
Outcomes and case studies
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
100+ cardiac measures analyzed
Automated analysis across comprehensive cardiac parameters
Better than human AI performance
CoreLab analysis utilizing AI software
Enhanced speed, accuracy and precision
Cardiac MRI and echocardiography analysis
5 minutes to 3 seconds
Echo capacity improvement mentioned in NICE Draft Guidance 2026 article
05 · Leadership
Leadership team
Leadership profiles and professional links from the current Company record.
James Moon
Chief Executive Officer
Charlotte Manisty
Director and Founder
Mark Westwood
Director and Founder
Antony Shimmin
Chief Operating Officer
Ed Critchley
Co-founder and Chief Commercial Officer
James Doherty
Chief Financial Officer
Julian Parker
Non Executive Director
Robert Merrifield
Head of CMR Software Development
06 · Company updates
Updates from Mycardium AI
Recent articles published on Mycardium AI's official website.
Shaping the Future of Health Innovation in our Home City
Read on Mycardium AICMR London Returns: A New Chapter for a Proven Community
Read on Mycardium AIMyCardium AI Becomes Approved Constellia Partner, Expanding Access for NHS and Public Sector
Read on Mycardium AINICE Draft Guidance 2026
Read on Mycardium AI07 · HAIC coverage
Coverage and analysis
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Company sources and channels
Curated official destinations from the active Company record.
09 · Market pathway
Additional Companies in this Market
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Cardiology & Cardiovascular Health
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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Linked research, clinical, and regulatory source pathways.
Expanded product, deployment, integration, and partnership research.
Record-level provenance and review context.