Securing Every Pregnancy: Diagnoly Raises €5.5M to Reinvent Ultrasound Through AI
- Around 50% of fetal abnormalities go undetected until birth.
- Thanks to advanced AI, Diagnoly aims to ensure safer fetal ultrasound exams, elevating prenatal screening to an unprecedented level of reliability.
- This funding round is led by Mutuelles Impact (managed by XAnge) and Newfund, joined by existing investor Les Business Angels des Grandes Écoles.
- The objectives: expand globally to benefit all women and further develop the technology by enhancing its precision and adapting it to detect additional pathologies.
(Lyon/Paris, Tuesday, April 8, 2025) Diagnoly, a pioneering DeepTech company specializing in AI-driven prenatal screening, announces its €5.5M Seed funding round, led by Mutuelles Impact—a social and environmental impact fund dedicated to health and social care, initiated by Mutualité Française and managed by XAnge—and Newfund, alongside existing investor BADGE and internationally renowned KOL physicians.
This new financing round will accelerate Diagnoly's technological development, aiming to transform fetal-maternal medicine and improve women's health through precise screening.
One mission: saving lives
Diagnoly's concept originated in late 2018 from the personal experience of Ivan Voznyuk (PhD in Applied Mathematics), during his wife's pregnancy and the numerous concerns raised during routine ultrasound check-ups: throughout the complex processes of pregnancy, what measures can be put in place to minimize the risks of missing physical abnormalities in the unborn child?
The project took shape at a hospital in Marseille over coffee between Ivan and Dr. Edwin Quarello (KOL physician, renowned obstetrician-gynecologist specialized in fetal cardiology), shortly after the birth of Ivan's daughter. Soon thereafter, Camille Dupont, a computer vision engineer, joined the team as CTO of Diagnoly.
These three experts observed that despite medical, academic, and industrial advancements, up to 50% of fetal heart defects still remain undetected before birth today [Bensemlali 2016, Garcia 2016, Millien 2018].
Prenatal detection of fetal abnormalities is crucial for obstetric care, as it significantly increases survival rates, improves quality of life, and reduces risks of disability.
Diagnoly was founded with the ambition of ensuring the safety of fetal ultrasound exams, simplifying decision-making, and enhancing prenatal detection of all fetal pathologies, beginning with cardiac and cerebral conditions.
“At Diagnoly, we believe no parent or healthcare provider should experience uncertainty when it comes to mother-fetal care. Our aim is to bring greater security and peace of mind to mothers and caregivers, improve clinical outcomes, and be a trusted partner for all healthcare professionals. This funding enables us to expand our AI-based screening solutions, providing healthcare providers with more precise, targeted, and accessible care for those who need it most.”
AI-Assisted Ultrasound Technology
Diagnoly's software ("Fetoly") is a medical device utilizing AI based on proprietary computer science and deep learning algorithms.
The company offers an innovative approach to digital ultrasound examination analysis. Its technology is the world’s first capable of analyzing ultrasound image streams in real-time, completely independent from cloud or internet connections.
Its development required several years of research to design unique deep learning and computer vision algorithms that are lightweight, efficient, and resilient to digital errors.
By eliminating the need for cloud connectivity, the company addresses a significant constraint, as many ultrasound machines are not network-connected. More importantly, this technology allows analysis of the entire ultrasound exam, significantly reducing dependency on the practitioner's expertise—a critical issue in fetal ultrasound, where operator experience greatly influences exam quality.
Running directly and in real-time on a tablet connected to the ultrasound device, Fetoly:
- analyzes the entire ultrasound examination
- automatically selects ultrasound images from the exam
- generates a structured report
By simplifying and standardizing pregnancy risk assessments, Fetoly enhances precision, efficiency, and prenatal detection of fetal pathologies. Diagnoly thus complements human expertise, significantly improving prenatal screening rates and reducing operator dependency.
This unique technology has already been certified in the United States (FDA clearance) and Europe (CE marking), and it complies with the ISO 13485 standard.
“Care in the perinatal field can still be significantly improved. One critical step involves medical professionals identifying at-risk situations for mother and fetus through ultrasound examinations during pregnancy. While this aligns fully with healthcare goals, current methods have notable limitations. That’s why we aim to continue developing and offering tools combining new technological advances with medical knowledge, supporting healthcare providers and reducing the risks of errors and oversight, thus enhancing care quality for mothers and their unborn children.”
Expanding Worldwide
With its recent CE and ISO 13485 certifications, Diagnoly's innovative software is already being used in multiple European countries. With this Seed funding, the company plans to expand its engineering and research teams, accelerate regulatory approvals, and broaden its deployment in new markets, notably the United States following FDA clearance. The goal: make real-time, AI-assisted fetal screening a new standard in healthcare.
“We are proud to support a solution that perfectly embodies the investment thesis of Mutuelles Impact: utilizing AI to advance preventive and efficient healthcare. By making ultrasound examinations more reliable for both expert and non-expert practitioners, this technology enables widespread obstetric screening, ensuring earlier care for all patients while reducing the mental burden on healthcare professionals. Diagnoly exemplifies the significant impact AI can have on tomorrow's healthcare.”
“We are delighted to support Diagnoly, a frontrunner in prenatal ultrasound. Their approach, which directly applies artificial intelligence to video streams, addresses a critical medical challenge by significantly improving fetal pathology detection. The team has demonstrated exceptional ability in transforming cutting-edge technology into a certified product, widely adopted and appreciated by practitioners. This is exactly the type of high-impact innovation our Newfund HEKA fund seeks to support.”
About Diagnoly:
Co-founded in March 2020 by Ivan Voznyuk (PhD in Applied Mathematics) and Dr. Edwin Quarello (KOL obstetrician-gynecologist), Diagnoly is an AI-powered medical screening company that significantly improves ultrasound care through cutting-edge artificial intelligence. Focused on prenatal mother-fetal medicine and women’s health, Diagnoly’s solutions enhance the accuracy of prenatal screening. A winner of the 2020 i-Lab competition, Diagnoly was recognized as a DeepTech company twice (March 2020 and January 2022). It raised €900k Pre-Seed in December 2021 and €5.5M Seed funding in April 2025, led by Mutuelles Impact (managed by XAnge) and Newfund, along with existing investor BADGE and KOL physicians.
For more information about Diagnoly and its mission to revolutionize medical screening, visit https://diagnoly.com.
Press Contact:
Estelle Monraisse
Alter’Com – Groupe Mascaret Partners
+33 6 60 41 81 52 – estelle@altercom-conseil.fr
About Mutuelles Impact:
Created in 2020 on the initiative of the Mutualité Française, Mutuelles Impact is the 1st mutualist investment fund with a social and environmental impact in the health sector. Its objective is to invest in and develop high-impact companies in the prevention, care pathway, and social care sectors. The Mutuelles Impact fund is managed by XAnge, in partnership with Investir&+. With over €95 million in assets, the fund is financed by 63 French mutual health insurers and 3 territorial players (l’Eurométropole de Strasbourg, la Banque des Territoires, and e-Meuse santé). It currently holds around twenty companies in its portfolio (startups, SMEs, mid-caps). More information is available at https://www.mutuellesimpact.fr/.
About Newfund:
Newfund is an early-stage VC fund supporting entrepreneurs with disruptive innovations across all sectors, with a particular focus on projects with international ambition. The fund invests in Seed rounds to help kick-start international expansion and continues to support entrepreneurs over the long term through follow-on investments. Through its healthtech fund Newfund HEKA, Newfund aims to finance 20 technology start-ups related to brain health. On the LP side, Newfund brings together the largest base of entrepreneurs and family offices in France for an innovation fund. For more information, visit https://newfundcap.com/.
About Business Angels des Grandes Écoles:
Founded in 2004 to support the creation and development of innovative businesses with high growth potential, the association Les Business Angels des Grandes Écoles (BADGE) is one of the largest networks of Business Angels in France, with more than 300 members. BADGE network connects entrepreneurs with Business Angel investors, organizes strategic support for these young companies, provides methodological support and training to Business Angels, and builds relationships with incubators, particularly those at prestigious schools. Since its creation, Les Business Angels des Grandes Écoles have funded 239 companies, contributing over €55 million. For more information, visit https://business-angels.info/
