Fetoly
Real-time AI ultrasound assistant for prenatal screening and fetal abnormality detection
Company profile
Company profile
Diagnoly is a medical AI company that has developed Fetoly, a real-time artificial intelligence ultrasound assistant designed to support clinicians performing prenatal ultrasound screening examinations. The company addresses a critical healthcare gap: up to 50% of fetal abnormalities remain undetected during pregnancy. Fetoly integrates seamlessly into existing clinical workflows by connecting directly to ultrasound systems via HDMI, providing real-time analysis and guidance without requiring changes to scanning techniques. The application automatically detects over 100 fetal anatomical structures aligned with ISUOG guidelines, performs live measurements, captures and annotates optimal images, and evaluates exam completeness. Operating entirely on-device with no cloud connection required, Fetoly ensures data privacy while delivering AI-powered support. The solution is trusted by clinicians across more than 20 countries and has achieved CE marking and FDA clearance. Diagnoly's technology enables more efficient, standardized, and reliable ultrasound examinations, helping clinicians work with greater confidence and consistency while improving fetal abnormality detection rates. The company is headquartered in Lyon, France, and serves healthcare providers including hospitals, clinics, and individual practitioners specializing in prenatal care.
Company description Diagnoly official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
On Premise deployment with recorded integration context.
Recorded integration context: Major ultrasound system brands via HDMI, PACS via DICOM Store, RIS/HIS via DICOM Worklist.
Company milestones
FDA clearance obtained, CE marking achieved, expansion to 20+ countries, mobile app availability on App Store and Google Play
Partnerships
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
Real-time AI ultrasound assistant for prenatal screening and fetal abnormality detection
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine · Mar 11, 2026
Clinical validation
No linked records are currently available.
Regulatory
K251368 · 510k · Sep 12, 2025
FETOLY-HEARTK241380 · 510k · Sep 11, 2024
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
High precision detection with minimal false positives
Automated detection of key fetal views with minimal false negatives
High engagement and real world clinical usage
Instantly detected, aligned with ISUOG guidelines
Fetal cardiology training and securing key fetal heart views with abnormality detection
Real-time AI helps secure key fetal heart views and spot abnormalities with more confidence
Fetal brain radiology support - staying on-axis, guiding correct planes, confirming view quality, and ensuring no key structure is missed
99% customer satisfaction with high engagement and real-world clinical usage
05 · Leadership
Leadership profiles and professional links from the current Company record.
Ivan Vonznyuk
CEO & Co-Founder
Edwin Quarello
Chief Medical Officer (CMO) & Co-Founder
Camille Dupont
CTO & Founding Team Member
Damien Lisse
Head of Quality and Regulatory Affairs
Joseph André
Chief of Staff
Natasha MarCom
Global Marketing Leader
06 · Company updates
Recent articles published on Diagnoly's official website.
No Company updates are currently listed.
07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
Companies that apply AI to analyze medical images for diagnostic purposes, workflow optimization, or clinical decision support. Covers general radiology (X-rays, CT scans, MRIs, ultrasounds) across multiple organ systems, as well as specialized imaging in ophthalmology and dermatology.
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