
Diagnoly helps clinicians improve prenatal screening by providing real‑time AI analysis of fetal ultrasound to detect abnormalities and ensure complete exams. It builds Fetoly, a DeepTech B2B SaaS and medical device that uses AI and deep learning models integrated with ultrasound systems to provide on‑device, real‑time feedback during scans. Fetoly analyzes anatomical landmarks, detects over 100 fetal abnormalities, validates exam completeness against ISUOG guidelines, and automates repetitive measurements to increase consistency. The solution runs locally on mobile devices and remains compatible with major ultrasound platforms without requiring cloud services, preserving clinical data control. Diagnoly targets obstetricians and healthcare providers and holds FDA clearance for Fetoly‑Heart and CE marking for fetal heart and brain analysis.

Diagnoly helps clinicians improve prenatal screening by providing real‑time AI analysis of fetal ultrasound to detect abnormalities and ensure complete exams. It builds Fetoly, a DeepTech B2B SaaS and medical device that uses AI and deep learning models integrated with ultrasound systems to provide on‑device, real‑time feedback during scans. Fetoly analyzes anatomical landmarks, detects over 100 fetal abnormalities, validates exam completeness against ISUOG guidelines, and automates repetitive measurements to increase consistency. The solution runs locally on mobile devices and remains compatible with major ultrasound platforms without requiring cloud services, preserving clinical data control. Diagnoly targets obstetricians and healthcare providers and holds FDA clearance for Fetoly‑Heart and CE marking for fetal heart and brain analysis.
Product: Fetoly — on-device, real-time AI for fetal ultrasound quality assurance and landmark/abnormality detection
Regulatory: FDA clearance for Fetoly-Heart and CE marking for fetal heart and brain analysis
Business model: DeepTech B2B SaaS / medical device targeting obstetricians and healthcare providers
Funding: Seed round Apr 8, 2025 — €5.5M
HQ: Lyon, France
Prenatal screening quality assurance and fetal abnormality detection during obstetric ultrasound
2020
Medical Equipment Manufacturing
€5.5M
Seed round announced to accelerate development of AI prenatal-screening technology; participation from XAnge and existing investors including Les Business Angels des Grandes Écoles (BAdGE)
USD 7,048,095
“Includes participation from Mutuelles Impact, Newfund, XAnge, Les Business Angels des Grandes Écoles, BADGE and other angel / impact investors”
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Start-up activity
DIAGNOLY is a DeepTech start-up headquartered in Lyon, France. We are redefining obstetric and maternal-fetal medicine through real-time AI in ultrasound.
We are looking for an experienced Quality and Regulatory Engineer who is ready for the challenge of maintaining the certification and improving an AI-powered medical device that will transform the domain of obstetric ultrasound.We are seeking candidates who already have a strong background working within quality and regulation of software medical devices.
Responsibilities:
- Definition of quality and regulatory strategies
- Preparation of the complete Design History Files (specifications, risk management, V&V) in collaboration with the R&D team
- Preparation and update of CE marking and 510(k) files
- Management of regulatory submissions and audits
- Maintenance and improvement of the Quality Management System, including CAPA, change control, suppliers and complaints
Requirements:
- Excellent knowledge of MDR 2017/745, 21CFR, ISO 13485 and software standards and guidance
- Successful experience of bringing to EU or US markets at least one medical device of class IIa (or higher)
- At least 5 years of experience in the industry
Preferred
- Experience in AI software
- Good communication in French and English
- Motivated to grow and take on diverse responsibilities
- Startup experience
If you are interested, do not hesitate to write to us on careers@diagnoly.com. Please provide your CV and a short motivation for this position in your email.