Each year, thousands of fetal pathologies go unnoticed during follow -up ultrasounds. In question: a strong dependence on human expertise, variability in clinical practices and inequality in access to advanced equipment. To respond to this structural flaw, the startup Dianoly is betting on an on -board artificial intelligence capable of analyzing, in real time and without network connection, the whole of a fetal ultrasound examination. An approach that intends to standardize the quality of diagnostics, regardless of the skill level of the practitioner.
Ultrasound examination, an act still too uncertain
Obstetric ultrasound remains a high subjectivity exercise today. The rate of non-detection of cardiac malformations in the fetus remains greater than 50 % in many developed countries. The quality of the images produced, the rigor of the analysis protocol, and the operator’s experience directly influence the reliability of screening.
Unlike other areas of medicine where biomarkers, automated tests or standard examinations make it possible to make diagnostics make, ultrasound remains marked by difficult to compress heterogeneity. In some expert centers, the detection rate reaches 90 %. Elsewhere, it drops to less than 40 %. This variability involves the health of the fetus, the anticipation of care, even the life of the newborn.
An on -board AI, independent of the cloud and the operator
Diagnoly introduces a technological rupture by designing an analysis device for ultrasound images operating directly on a tablet connected to the medical device. The software, baptized Fetolyis based on algorithms that have owned Deep Learning and Computer Vision, designed to operate without internet access, locally, and in real time.
Concretely, Fetoly Analyze the entire video flow of the ultrasound exam, automatically selects the relevant images and generates a structured report. The objective: to guarantee a constant level of precision, regardless of the practitioner and his level of expertise, and to reduce the risk of omission or error.
This approach meets several major constraints in the sector: the low connectivity of ultrasound devices in establishments, the shortage of specialists in fetal medicine, and the need to strengthen prevention rather than reaction.
A standardization by technology
By introducing a layer of algorithmic intelligence at the heart of the medical examination, Diangoly transforms ultrasound into a semi-automated act, where the analysis assisted by IA becomes a guarantor of reliability. This paradigm change does not eliminate the role of the doctor, but offers him homogeneous, constant and verifiable technical support.
The FDA certification and this obtained by the company, as well as its compliance with the ISO 13485 standard, give this technology a level of credibility rarely reached at this stage of maturity in digital medical devices.
A global ambition carried by medical experts
Founded in 2020 by Ivan Voznyuk (Doctor of Applied Mathematics) and Dr. Edwin Quarello (gynecologist-obstetrician specializing in fetal cardiology), Diangoly was born from a concrete clinical need, experienced personally by its founder. The team was quickly supplemented by Camille Dupont, an engineer specializing in computer vision, now CTO.
This triptych – mathematics, medicine, AI – Structure The proposal for the value of diagnoly: converging knowledge to build a robust clinical tool. The company collaborates closely with KOL (Key Opinion Leaders) doctors in perinatality, in order to anchor its development in real field practices.
Financing and perspectives
Diagnoly has lifted 5.5 million euros in April 2025 in a financing round in Seedled by Mutual impactthe impact fund managed by Xange at the initiative of the French mutuality, and by Newfund via his specialized health vehicle Newfund Heka. The historic investor BADGE (Business Angels of the grandes écoles), as well as several expert doctors, have also participated.
This funding aims to strengthen technical teams, accelerate deployment in Europe and the United States, and expand the use of AI to other types of fetal pathologies. It brings the total amount raised by Diagnoly to 6.4 million euros Since its creation.
