Fetal EchoScan
BrightHeartFetal EchoScan is an AI-powered software tool that assists physicians in analyzing fetal heart ultrasound videos during the second trimester. It helps identify suspicious anatomical findings that may indicate fetal congenital heart defects, enhancing diagnostic accuracy and aiding clinical decision-making without replacing standard care.
Intended Use
Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams.
Technology
The device is a cloud-based software-only AI that uses neural networks to detect suspicious fetal cardiac radiographic findings from fetal ultrasound video clips containing standard cardiac views (4-chamber, left and right ventricular outflow tracts). It outputs frame-by-frame classifications as present, absent, or inconclusive for each suspicious finding.
Performance
Performance was validated using 877 fetal ultrasound exams from multiple centers with pediatric cardiologist truthing. Standalone testing showed high sensitivity (up to 98.7%) and specificity (up to 100%) for detecting suspicious findings. A multiple-reader study showed a significant improvement in reader diagnostic accuracy, sensitivity, and specificity when aided by the software.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/7/2024
3 months - 2
FDA Approval
11/14/2024
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