EchoConfidence (USA)
Mycardium AI LimitedEchoConfidence (USA) is an AI-powered software that helps clinicians analyze transthoracic echocardiogram images. It automatically classifies views, segments cardiac structures, measures cardiac function, and performs Doppler assessments, improving the efficiency and accuracy of cardiac image interpretation for adults and adolescents.
Intended Use
Software as a Medical Device that displays images from a transthoracic echocardiogram, assisting in reviewing images, making measurements and writing a report for cardiac anatomy, structure, and function including automatic view classification, cardiac structure segmentation, cardiac function measures, and Doppler assessments.
Technology
EchoConfidence uses AI to automatically segment and quantify cardiac structures and functions from echo images. The system includes automatic view classification and outputs multiple measurements (>100) including Doppler assessments. It allows manual editing of contours and is based on software verification, validation, and risk management standards (EN ISO 14971, IEC 62304, IEC 62366).
Performance
Performance testing used 200 echocardiographic cases from US CoreLab with measurements by 3 expert readers; accuracy assessed by mean absolute error compared to experts showed AI performed as well or better than variability between experts. Demographic and device vendor variability was analyzed with consistent results. Validation data was separate from training data, supporting substantial equivalence and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/5/2025
3 months - 2
FDA Approval
6/30/2025
Other devices from Mycardium AI Limited
- 1CMR Pro2024 • 510K
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