FETOLY
Overview
Diagnoly is a pioneering DeepTech company specializing in AI-driven prenatal screening. Their flagship product, Fetoly, is an AI-powered medical software device designed to enhance fetal ultrasound examinations with real-time analysis and instant insights. It aims to make obstetric screening more accurate, consistent, and less operator-dependent, addressing the challenge of undetected fetal abnormalities during pregnancy.
Fetoly operates locally on a tablet device, connecting to existing ultrasound systems via HDMI, and processes over 100,000 ultrasound images per exam in real-time. This approach ensures data security and privacy by not relying on internet or cloud dependency, meaning patient data never leaves the hospital. The tool assists healthcare professionals in verifying exam completeness, automating image selection, and detecting fetal heart and brain anomalies by measuring anatomical keypoints according to ISUOG guidelines.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Real-time Quality Assurance for fetal ultrasound exams
- Automatic Image Selection and documentation
- Smarter Screening with Real-Time AI for anomaly detection
- Automated measurement of fetal heart and brain anatomical keypoints
- Simple Connectivity to existing ultrasound systems (HDMI)
- Large Compatibility with major ultrasound brands
- Intuitive Design and easy-to-use interface
- 100% Secure: operates locally without internet or cloud dependency
- Advanced Data Protection: no patient data accessed or stored by vendor
- Continuous verification of exam completeness and quality criteria
Use Cases
- Enhancing fetal ultrasound screenings for accuracy
- Detecting fetal heart and brain anomalies instantly
- Standardizing fetal ultrasound examinations according to ISUOG guidelines
- Reducing operator dependence in ultrasound procedures
- Improving prenatal care outcomes through early detection
- Automating image capture and documentation to PACS
What Physicians Need to Know
Leverage FETOLY for real-time, AI-driven feedback during fetal ultrasound examinations to ensure scan completeness and adherence to ISUOG guidelines. Utilize its automated measurement and anomaly detection capabilities for fetal heart and brain to enhance diagnostic accuracy and facilitate timely interventions. The local processing ensures data security and privacy. This tool can significantly reduce operator variability and streamline workflow, allowing for more consistent and high-quality prenatal screening.
FETOLY is designed for effortless integration, connecting to existing ultrasound systems via a single HDMI cable and compatible with all major ultrasound brands. It is available as an app on iOS (iPad) and Google Play, and operates locally on the device without internet or cloud dependency, ensuring data security. Diagnoly has a collaboration with GE HealthCare to integrate FETOLY within their Voluson women's health ultrasound systems, and it can send captured images and reports to PACS.
Details
| Category | OB/GYN AI |
| Pricing | Contact vendor for pricing — Free trial available |
| Deployment | Mobile application (tablet-based), operates locally on the device. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Yes AI-estimated Fetoly has received U.S. Food and Drug Administration (FDA) 510(k) clearance K241380 for real-time fetal heart anatomy analysis (2024) and K251368 for fetal brain and heart completeness assessment and biometric measurements (Decision Date: September 12, 2025). |
| Integrations | |
| EHR | Not specified |
| Specialties | Maternal-Fetal Medicine, Obstetrics & Gynecology |
What the Web Says
FETOLY by Diagnoly is a real-time AI ultrasound assistant designed to help clinicians detect fetal abnormalities, reduce risks, and perform more consistent and confident ultrasound exams during the second and third trimesters of pregnancy. It operates locally on a tablet (iOS and Android) and integrates with most ultrasound systems, providing instant feedback and automated measurements without requiring cloud connectivity. The application has received positive feedback from early adopters and clinicians, who highlight its clinical value and ease of integration into existing workflows.
Overall: PositiveStrengths
- Real-time AI assistance for fetal ultrasound examinations.
- Helps detect fetal abnormalities and improve diagnostic confidence.
- Standardizes ultrasound exams and ensures completeness by analyzing over 100 fetal anatomical structures.
- Provides automatic selection and annotation of ultrasound images and live ratio measurements.
- 100% localized AI solution, meaning no cloud or internet connection is required, enhancing data security and streamlining workflows.
- Compatible with most ultrasound systems and available on iOS and Android tablets, allowing for seamless integration into existing clinical setups.
Limitations
- Limited information available from independent tech reviewers, Reddit, G2, and Capterra, making a comprehensive external assessment challenging.
- Not intended for use during the first trimester of pregnancy, as it can lead to errors in completeness function.
- Cannot be used for screening purposes, as it may contribute to false negative screenings.
- Requires a license from Diagnoly and an internet connection for initial validation and updates (at least every 30 days).
- The tablet used for the application should be used alone to avoid interference and unauthorized access.
- Data exported to the device becomes the user's responsibility.
Based on reviews from: Diagnoly: Healthcare Innovation with Fetoly for Clinicians, Fetoly | GE HealthCare (United States), Testimonials - Diagnoly, Fetoly | GE HealthCare (Global English), Diagnoly Introduces Real-Time AI for Fetal Ultrasound on iOS | Applied Radiology, Fetoly-AI Ultrasound Assistant - App Store - Apple, Your Trusted AI Ultrasound Assistant - YouTube, Diagnoly launches Fetoly fetal ultrasound AI app on iOS | AuntMinnie, Bringing AI Into Prenatal Ultrasound - Tech Trends Diagnoly Launches Fetoly AI Prenatal Ultrasound App on iOS, Diagnoly introduces the Next Generation of Fetoly for AI-Assisted Fetal Ultrasound with Full Fetus Anatomy at the FMF World Congress 2026, September 12, 2025 Diagnoly Nima Akhlaghi Associate Director, Digital Health Regulatory Affairs MCRA, LLC 505 Park Avenue, 1 - accessdata.fda.gov, GE HealthCare, Diagnoly Team Up to Advance AI-Enabled Fetal Ultrasound, GE HealthCare strengthens AI offerings with Diagnoly collaboration to advance AI-enabled fetal ultrasound, Fetoly-AI Ultrasound Assistant - Apps on Google Play
Last updated: 2026-07-18
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2026 Imaging Conference and Expo Recap
