EchoMeasure
iCardio.aiEchoMeasure by iCardio.ai is an AI-powered software that analyzes previously acquired cardiac ultrasound images to automatically measure key cardiac anatomical parameters. It assists cardiologists and healthcare professionals by providing accurate measurements for clinical decision-making, enhancing efficiency and supporting diagnostic review.
Intended Use
Software to process previously acquired DICOM-compliant cardiac ultrasound images and provide automated estimation of several cardiac measurements to support healthcare practitioners for clinical decision-making in adult patients.
Technology
The software uses machine learning algorithms for echocardiographic view classification, image quality assessment, key frame selection, automated keypoint detection, and segmentation of cardiac structures to compute multiple cardiac parameters from ultrasound images. It integrates these into a browser interface for clinicians to review, accept, or edit the automated measurements.
Performance
The software underwent retrospective standalone performance validation on 200 echocardiography studies from two clinical US sites with diverse patients and ultrasound systems, comparing automated measurements against ground truth from experienced clinicians. Statistical analysis showed the software met predetermined accuracy thresholds for all cardiac measurements with no bias by demographics or equipment and exhibited good agreement with the ground truth annotations.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/21/2024
4 months - 2
FDA Approval
10/10/2024
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