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FETOLY-HEART is intended to analyse fetal ultrasound images and clips 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. FETOLY-HEART is indicated for use during routine fetal heart examination of 2nd and 3rd trimester pregnancy (gestational age: from 17 to 40 weeks).

FETOLY-HEART is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists, and pediatric cardiologists (designated as healthcare professionals i.e. HCPs) to perform fetal ultrasound examinations of the fetal heart in real-time. FETOLY-HEART can be used by HCPs during fetal ultrasound examinations in the second and third trimesters (gestational age window: from 17 to 40 weeks). The software is intended to assist HCPs in the completeness assessment of the fetal heart ultrasound examination in accordance with national and international guidelines. To utilize FETOLY-HEART, the software needs to be installed on a hardware device which is connected to an Ultrasound Machine through an HDMI connection. The software receives ultrasound images captured by the connected Ultrasound Machine in real-time. The software's frozen deep learning algorithm, which was trained by supervised learning, analyzes images of this ultrasound image stream to detect heart views and quality criteria within those views. The software provides the following user-accessible information: - . Examination completeness: the software displays in real-time which heart views and quality criteria are verified by the software during the examination. It is the main and principal output of the FETOLY-HEART device. The verified heart views and quality criteria are accessible by clinicians at any moment of the ultrasound examination, in real-time. - . Completeness illustration: the software selects an image subset that illustrates the verified views and quality criteria. These images can be reviewed by clinicians to verify the views and criteria's presence. This is a secondary output of the FETOLY-HEART device. Optionally, clinicians can display detected quality criteria localization on selected images.