1CMR Pro
by Mycardium AI Limited
· Based in United Kingdom →
— Revolutionizing Cardiac MRI with our FDA 510(k) cleared and CE Class IIB cleared analysis software, enhancing speed, accuracy and precision.
Contact for pricing
Regulatory Status Disclosed
Overview
Mycardium AI’s 1CMR Pro is an advanced AI tool designed for cardiac MRI reporting. It leverages convolutional neural networks, trained on over 700,000 cine images and 60,000 expert segmentations, to identify cardiac structures and generate precise volumetric and functional measurements. Built on over a decade of quantitative CMR research at University College London, it delivers regulatory-grade automation that enhances diagnostic precision, reproducibility, and efficiency in both clinical and research environments. The software ensures clinician control with fully visible and editable contours, allowing verification, adjustment, and approval of every result. Processing runs locally through a secure web-based platform, ensuring no patient data is transmitted beyond the institution.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-enhanced Cardiac MRI Reporting
- Automated volumetric and functional measurements
- Convolutional neural networks trained on extensive datasets (700,000 cine images, 60,000 expert segmentations)
- Local data processing (no patient data transmitted beyond institution)
- Transparent and editable contours for clinician control
- Regulatory-grade automation for enhanced precision and reproducibility
- Achieves up to 40% higher precision than manual analysis
- Validated across multi-centre datasets
- Compatible with 1.5T and 3T CMR acquisitions
- Integration with PACS/EHR for saving results
Use Cases
- Clinical cardiac MRI analysis and reporting
- Cardiac research environments
- Drug development and clinical trials support
- Diagnosis and management of heart failure
- Assessment of cancer therapy heart injury
- Personalized treatment planning based on precise cardiac measurements
What Physicians Need to Know
Cardiac CT/MRI Analysis
1CMR Pro specializes in Cardiovascular Magnetic Resonance (CMR) image analysis, utilizing convolutional neural networks trained on over 700,000 cine images and 60,000 expert segmentations. It provides automated quantification of left and right ventricular volumes and function, as well as atrial areas and strain parameters. The software is compatible with 1.5T and 3T CMR acquisitions and achieves up to 40% higher precision than manual analysis. It is FDA 510(k) cleared and CE Class IIB cleared.
Heart Failure Risk Prediction
While 1CMR Pro directly provides precise volumetric and functional measurements from CMR images, which are crucial for assessing heart failure, the search results indicate that CMR radiomics can offer incremental predictive value for incident cardiovascular diseases, including heart failure, when integrated with machine learning techniques.
Coronary Artery Assessment
1CMR Pro analyzes CMR images, which are a guideline-established multi-parametric imaging modality for assessing global and regional cardiac function, myocardial perfusion, viability, tissue characterization, and coronary artery anatomy. CMR is recognized for its accuracy in detecting stable coronary artery disease (CAD) and is a recommended option for patients with suspected acute coronary syndromes (ACS) at intermediate risk.
Cardiac Monitoring Integration
The software processes data locally through a secure web-based platform, ensuring no patient data is transmitted beyond the institution. It saves results back to Picture Archiving and Communication Systems (PACS) and Electronic Health Records (EHR). 1CMR Pro integrates with GE or Siemens MRI systems.
AHA/ACC Guideline Alignment
1CMR Pro enhances the diagnostic precision, reproducibility, and efficiency of Cardiac MRI, an imaging modality that is well-represented in AHA/ACC guidelines. CMR holds Class I or Class IIa recommendations for various clinical scenarios, including stress CMR for intermediate-risk patients with suspected ACS and known CAD, and for distinguishing myocarditis.
Physician Tip
1CMR Pro offers enhanced precision and efficiency in CMR analysis, providing automated, reproducible outputs. Clinicians maintain full control with transparent, editable contours, allowing verification and adjustment of every result. This can standardize imaging across technologists and locations, reducing variability and potentially aiding in settings where highly experienced CMR interpretation specialists may be limited.
1CMR Pro operates as a zero-footprint Software as a Medical Device (SaMD) that processes patient pixel data strictly in local memory within the hospital network (PACS area). It integrates seamlessly with existing PACS/EHR systems for saving results and is compatible with GE and Siemens MRI systems.
Details
| Category | Cardiology AI |
| Pricing | Contact for pricing — Not publicly disclosed; likely enterprise/quote-based. |
| Deployment | On-premise (software installed on hospital's own computer, processing data locally via a secure web-based platform) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated 1CMR Pro has FDA 510(k) clearance (K242062) as a Class II medical device (21 CFR 892.2050). It is indicated for displaying, analyzing, and transferring DICOM cardiovascular images acquired in Cardiovascular Magnetic Resonance (CMR) scanners, specifically for structure, function, and flow in the heart and major vessels. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Radiology |
Ratings & Reviews
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Press & Coverage
Hardian Health
MyCardium's quadruple regulatory cleared cardiac AI platform
MyCardium AI, a UK-based company, has achieved quadruple regulatory clearance for its cardiac AI platform, including 1CMR Pro and EchoConfidence, with strategic partner Hardian Health. These AI-powered tools aim to improve the consistency and accuracy of cardiac MRI and echocardiography measurements.
2025-11
X-ray Interpreter
1CMR Pro | FDA Radiology AI Device - X-ray Interpreter
1CMR Pro, a medical software tool by MyCardium AI, received FDA 510(k) approval on November 15, 2024. It provides a user interface for viewing and analyzing cardiac MRI images using AI, automating segmentation and quantification of cardiac structure and function.
2024-11
Hardian Health
From AI regulation to NHS adoption: Insights from Hardian Health Tech Summit 2026
Michael Walker from MyCardium AI discussed the company's journey from an academic concept to a globally scaling med-tech company at the Hardian Health Tech Summit 2026. Their AI, including 1CMR Pro, improves test-retest repeatability in cardiac imaging by 40% compared to human experts.
2026-05
FDA
510(k) Premarket Notification - FDA (K242062)
This FDA document details the 510(k) Premarket Notification for 1CMR Pro by Mycardium AI Limited, approved on November 15, 2024. It outlines the device's intended use, technological characteristics, and non-clinical performance testing results, demonstrating its accuracy and precision in cardiac MRI analysis.
2024-11
Metric Search
The Radiology Rundown 6th Edition - Metric Search
MyCardium AI, a UK-based company, received FDA 510(k) clearance for their 1CMR Pro Software in the Echo imaging space, as highlighted in The Radiology Rundown's December edition reviewing RSNA 2024.
2024-12
medRxiv
Acute myocardial infarction releases more troponin per unit of late gadolinium enhancement mass compared to acute myocarditis | medRxiv
A study published on medRxiv in February 2026 utilized 1CMR Pro (MyCardium AI Limited) for CMR post-processing and analysis in research comparing troponin release in acute myocardial infarction and acute myocarditis.
2026-02
Signify Research
Ultrasound Frequency and Funding Heat Up - Signify Research
MyCardium AI's existing cardiology portfolio, which previously focused on MRI imaging with 1CMR Pro, has expanded into ultrasound with the FDA 510(k) clearance of its EchoConfidence product.
2025-08
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing - Innolitics
1CMR Pro by Mycardium AI Limited is cited as an example of an AI/ML SaMD that used independent US-based experts for ground truth validation in its clinical validation process.
2025-09
Frequently Asked Questions
1CMR Pro integrates into your workflow by processing DICOM cardiovascular images from CMR scanners locally through a secure web-based platform, then saving results back to PACS/EHR systems. It automates precise volumetric and functional measurements of left and right ventricles, as well as atrial areas and strain parameters, with all contours remaining visible and editable for clinician review and adjustment.
Yes, 1CMR Pro has received FDA 510(k) clearance (K220624) and has been developed with full consideration and compliance with the EU AI Act's High-Risk criteria. Patient data privacy is ensured as processing runs locally on your institution's secure web-based platform, meaning no patient data is transmitted beyond your facility.
1CMR Pro is built on over a decade of quantitative CMR research from University College London, trained on over 700,000 cine images and 60,000 expert segmentations. It emphasizes transparent, editable contours, allowing clinicians full control and verification of every result, and has demonstrated superior reproducibility, accuracy, and efficiency compared to manual analysis and other approved software.
Specific pricing details for 1CMR Pro are not publicly available in the provided information. For pricing models, subscription costs, or per-use fees, it is recommended to contact MyCardium AI Ltd. directly.
The AI analysis components of 1CMR Pro are not intended for use in patients with known congenital cardiac conditions. While highly accurate, it is designed as an assistive tool, and clinicians retain full control to verify, adjust, and approve all results.
1CMR Pro's performance has been independently validated and published in peer-reviewed literature, demonstrating superior reproducibility, accuracy, and efficiency compared to both clinicians and other approved CMR software. Clinical validation included non-clinical performance testing on independent datasets, confirming acceptable accuracy and precision of output measurements and segmentations.
1CMR Pro serves as an assistive tool designed to enhance diagnostic precision, reproducibility, and efficiency, not to replace physician interpretation. All generated contours and results remain fully visible and editable, ensuring clinicians can verify, adjust, and approve every output.
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| Last Verified: 2026-04-21 | First Added: 2026-04-21