FETOLY-HEART is a software tool that helps healthcare professionals during fetal ultrasound exams by automatically detecting key fetal heart views and assessing the quality of those views in real-time. It supports clinicians in ensuring a complete and accurate fetal heart examination, particularly in the second and third trimesters of pregnancy, improving diagnostic confidence and workflow efficiency.
Intended Use
Fetoly-Heart is intended to analyze fetal ultrasound image sequences using machine learning techniques to automatically detect heart views and quality criteria within the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images. It is indicated for use during routine fetal heart examination of 2nd and 3rd trimester pregnancy (gestational age: from 17 to 40 weeks).
Technology
FETOLY-HEART is AI software installed on a hardware device connected via HDMI to an ultrasound machine. It analyzes real-time ultrasound images using a frozen deep learning algorithm trained by supervised learning to detect fetal heart views and quality criteria. It displays examination completeness and illustrative image subsets to clinicians.
Performance
Performance testing on 480 patient cases with 2,288 ultrasound images from 7 clinical sites indicated that FETOLY-HEART detects fetal heart views with sensitivity and specificity ≥ 85%, identifies quality criteria with sensitivity and specificity ≥ 90%, and accurately localizes quality criteria bounding boxes with mean IoU ≥ 50%. The testing included diverse clinical subgroups and demonstrated robustness and generalizability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/15/2024
3 months - 2
FDA Approval
9/11/2024
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.