News

Lyon, France – August, 2024. We are pround to announce that Fetoly-Heart, our flagship device, has been cleared by the FDA under the 510(k) pathway.

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.

Recently, [Van Nisselrooij 2019, Pinto-Morris 2020, Pinto-Henry 2020] investigated the reasons behind the fetal heart pathologies missed during 2nd trimester ultrasound examination. They found that in 49% of cases, the lack of skills in acquiring the ultrasound images, i.e. the ultrasound data did not correspond to the medical directives and therefore was not sufficient to make the correct conclusions.

To overcome this challenge and improve the prenatal detection rate of fetal cardiac pathologies, it is essential to empower practitioners with consistent and expert-level accompaniment. This approach aims to reduce user dependency and promote a more homogeneous quality of examination, thereby ensuring more accurate and reliable fetal screening results.

Fetoly-Heart is the first ever real-time software solution ensuring the completeness of fetal cardiac ultrasound examinations across 50+ anatomical heart landmarks which are associated with the majority of fetal cardiac malformations.

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Ivan Voznyuk, CEO of Diagnoly, stated: “Being granted FDA 510(k) clearance for our first flagship device marks a significant milestone for Diagnoly. This achievement reflects years of hard work from our exceptional scientific and regulatory team, and our partners. We are excited to bring this innovation to the OB/GYN market. Following the rigorous FDA approval process, Fetoly-Heart has demonstrated proven effectiveness in the automatic detection of heart views associated with exhaustive quality standards, providing healthcare facilities a reliable solution to enhance the quality of ultrasound examinations. This clearance also paves the way for our future AI-driven products aimed at detecting fetal abnormalities.”