EchoConfidence (USA)
by Mycardium AI Limited
· Based in United Kingdom →
— Empowering echocardiography with world-beating human-in-the-loop AI across 100+ measures.
Not available publicly; likely enterprise/custom pricing.
Regulatory Status Disclosed
Overview
EchoConfidence is an AI-powered Software as a Medical Device (SaMD) developed by Mycardium AI Limited. It is designed to revolutionize cardiac imaging and diagnostics by assisting clinicians in the analysis of transthoracic echocardiogram images. The software automates crucial tasks such as view classification, segmentation of cardiac structures (including left and right ventricles, chamber walls, atria, and great vessels), measurement of cardiac function, and Doppler assessments.
This technology aims to deliver speed, precision, and confidence in every scan, enhancing diagnostic accuracy, streamlining clinical workflows, and improving reporting efficiency for adult and adolescent patients requiring cardiac assessments. EchoConfidence integrates human oversight with AI capabilities to provide faster and more precise cardiac evaluations.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered transthoracic echocardiogram analysis
- Automatic view classification
- Segmentation of cardiac structures (ventricles, atria, walls, great vessels)
- Measures of cardiac function
- Doppler assessments
- Assists in reviewing images and making measurements
- Assists in writing reports
- Human-in-the-loop AI capabilities
- Outputs over 100 measurements
- Allows manual editing of contours
Use Cases
- Enhancing echocardiography analysis in hospitals and clinics
- Improving diagnostic accuracy in cardiac assessments
- Streamlining clinical workflows for echocardiogram interpretation
- Automating heart measurements with super-human precision
- Supporting next-generation treatments in cardiology
- Reducing clinician workload in cardiac imaging analysis
Details
| Category | Cardiology AI |
| Pricing | Not available publicly; likely enterprise/custom pricing. — Not available. |
| Deployment | Software installed on hospital's own computer, connected to imaging systems (e.g., echocardiogram machines/PACS). |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated EchoConfidence (USA) has received FDA 510(k) clearance (K250670) as a Class II Medical Image Management And Processing System (Regulation Number: 21 CFR 892.2050, Product Code: QIH). It is cleared as Software as a Medical Device (SaMD) for analyzing transthoracic echocardiogram images in adults and adolescents. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Critical Care, Emergency Medicine |
Ratings & Reviews
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Press & Coverage
Constat
EchoConfidence (USA) (K250670) u2014 FDA 510(k) evidence - Constat
EchoConfidence (USA), a Software as a Medical Device (SaMD) by Mycardium AI Limited, received FDA 510(k) clearance on June 30, 2025, for its AI-powered analysis of transthoracic echocardiogram images. The clearance was based on a validation study and addresses cybersecurity in medical devices.
2026-07
RadAI Slice
EchoConfidence (USA) | FDA Radiology AI Device - X-ray Interpreter
EchoConfidence (USA) is an AI-powered software that helps clinicians analyze transthoracic echocardiogram images by automatically classifying views, segmenting cardiac structures, measuring cardiac function, and performing Doppler assessments. It received FDA approval on June 30, 2025, after a submission on March 5, 2025.
2025-06
FDA
K250670 - 510(k) Premarket Notification - FDA
This official FDA document details the 510(k) premarket notification for EchoConfidence (USA) by Mycardium AI Limited, confirming its classification as a Class II Medical Image Management and Processing System. The document outlines the substantial equivalence determination and relevant regulatory requirements.
2025-06
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances - Innolitics
EchoConfidence (USA) by Mycardium AI Limited is listed among the 92 AI/ML-related FDA clearances in 2025, specifically within the cardiology AI/ML SaMD category. The article provides an overview of significant clearances in the field for that year.
2026-01
Hardian Health
Mycardium AI Limited - HaRi - Hardian Health
Hardian Health lists Mycardium AI Limited as a manufacturer with devices including EchoConfidence (USA) registered in the US. The company aims to improve healthcare system performance and patient outcomes by analyzing cardiac images using AI algorithms.
2026-07
Innolitics
AI Platform 2.2 (AIP002) (K260217) u2014 FDA 510(k) | Innolitics
This article mentions EchoConfidence (USA) (K250670) by Mycardium AI Limited with a clearance date of June 30, 2025, in the context of other FDA 510(k) clearances for AI/ML medical devices.
2026-02
Videos
Product demos, reviews, and walkthroughs for EchoConfidence (USA).
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Frequently Asked Questions
EchoConfidence (USA) is an AI-powered software designed to analyze transthoracic echocardiogram images, aiming to enhance the efficiency and accuracy of cardiac image interpretation for adults and adolescents. It automatically classifies views, segments cardiac structures, measures cardiac function, and performs Doppler assessments, assisting physicians in reviewing images, making measurements, and generating reports.
EchoConfidence (USA) is an FDA-approved Class II Software as a Medical Device (SaMD), indicating it meets specific regulatory standards for safety and effectiveness. As with any AI tool handling Protected Health Information (PHI), its use must comply with HIPAA regulations, requiring robust data security measures, de-identification of PHI, and potentially Business Associate Agreements (BAAs) with the vendor to safeguard patient privacy.
Yes, the cardiology field has over 200 FDA-cleared AI algorithms, offering various solutions beyond EchoConfidence (USA). Alternatives include Ultromics EchoGo Core for automated cardiac function analysis, Ligence Heart for comprehensive echo reporting, and AI-powered scribes like DeepCura or DeepScribe for documentation. Other AI tools are also emerging for tasks like ECG interpretation to detect structural heart disease.
Specific pricing for EchoConfidence (USA) is not publicly detailed and typically requires direct inquiry to the vendor. However, similar AI solutions in healthcare often operate on a subscription-based model, with some AI scribes for cardiology, for example, costing upwards of $299 per month. The overall cost can vary based on features, integration needs, and the scale of deployment within a practice or health system.
While EchoConfidence (USA) offers significant automation, it still allows for manual editing of contours, implying that physician oversight and judgment remain crucial. General limitations for AI in healthcare include potential issues with dataset diversity and generalizability, and AI tools are not a substitute for a cardiologist's expertise, requiring validation against current guidelines and clinical judgment. Additionally, the clinical evaluation of EchoConfidence specifically considered adults aged 18 and above, without independent evaluation for narrower age subgroups.
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| Last Verified: 2026-04-18 | First Added: 2026-04-18