Fetoly helps clinicians standardize fetal screening, support the detection of fetal abnormalities, improve efficiency, and increase confidence during fetal ultrasound examinations. 

Fetoly is currently indicated for examinations between the 17th and 40th gestational weeks (spanning the second and third trimesters).  Our team is actively working on expanding compatibility to include first-trimester ultrasound examinations. 

Obstetricians (OB/GYNs), Maternal-Fetal Medicine (MFM) specialists, midwives, sonographers, hospitals, clinics, fetal medicine centers, prenatal screening programs, and OEM (Original Equipment Manufacturer) partners involved in fetal and obstetric ultrasound. If you’d like to learn more, you can request a free trial (https://www.diagnoly.com/web-free-trial/), or contact our team [contact@diagnoly.com] for a personalized demonstration.  

• Real-time analysis of live ultrasound examinations  

• Real-time AI guidance during fetal ultrasound examinations  

• Live measurements supporting the identification of potential fetal abnormalities  

• Evaluation of exam completeness through analysis of over 100 fetal anatomical structures and landmarks  

• Automatic capture and annotation of optimal ultrasound images  

• Support for ultrasound quality assurance and exam standardization  

• No disruption to existing ultrasound workflows  

• PACS integration  

• Compatibility with major ultrasound systems  

• Local deployment with no cloud connection required  

• FDA-cleared and CE-marked features 

Yes. In addition to supporting clinical practice, Fetoly is widely used in educational and academic programs. Its real-time AI guidance, standard plane recognition, exam completeness assessment, and anatomical checklist help medical students, residents, sonographers, and clinicians develop and reinforce their fetal ultrasound skills. Fetoly also supports teaching hospitals and training centers by providing a standardized approach to fetal and prenatal ultrasound education. 

Fetoly analyzes image quality through automatic selection of optimal views and evaluates ratio measurements and anatomical landmarks for fetal heart and brain assessment. The system supports pathology detection and exam completeness in real time. 

Fetoly is compatible with major ultrasound systems and is currently compatible with GE HealthCare Samsung and Canon ultrasound platforms. 

Fetoly is FDA-cleared (https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241380.pdf) and CE0197 certified (https://www.diagnoly.com/2025/03/13/ce-marking/). The application is available in the following countries:  

[list of countries] 

Fetoly includes FDA-cleared features in applicable markets. Please contact our team for the latest regulatory information. 

Fetoly is commercially available in selected markets. Availability depends on local regulatory approvals and commercial distribution. Fetoly includes CE-marked and FDA-cleared features where applicable. In addition to our AI ultrasound solution, Diagnoly also offers educational programs to support healthcare professionals in fetal ultrasound and prenatal screening. Please contact our team for the latest information regarding product availability, educational programs, and regulatory status in your country. 

Fetoly evaluates exam completeness through real-time analysis of more than 100 fetal anatomical structures and landmarks, helping clinicians ensure that key anatomical views have been acquired during the examination. 

Fetoly supports clinicians by highlighting out of range ratio measurements and helping identify fetal abnormalities during ultrasound examinations. It is designed as a clinical decision-support tool and does not replace clinician expertise or judgment. 

AI provides standardized guidance and objective assessment during scanning, helping reduce variability between operators. 

AI can help support exam completeness assessment, improve consistency between operators, provide real-time guidance during ultrasound examinations, and help standardize fetal ultrasound examinations. 

AI provides consistent guidance, standardized quality assessment, and objective criteria that can help improve consistency across users and reduce variability between operators performing fetal ultrasound examinations.

AI in fetal ultrasound uses machine learning and computer vision technologies to assist clinicians during fetal ultrasound examinations by supporting image interpretation, ultrasound ratio measurements, exam completeness, and support clinical decision-making. 

A real-time AI ultrasound assistant continuously analyzes the ultrasound video during the examination. Unlike some competitors, you don’t need to capture an image, upload it, and wait for results. The AI provides immediate guidance while scanning, without interrupting the examination. 

AI can improve the quality, consistency, efficiency, and reliability of fetal screening and prenatal assessments. 

Yes. Fetoly’s features align with international guidelines such as ISUOG and are backed by scientific evidence from leading obstetrics and gynecology researchers. See our scientific committee

Fetoly application supports clinicians by assisting with the assessment of cardiac views and ratio measurements during fetal ultrasound examinations.

Yes. Fetoly features standard plane recognition and an anatomical checklist to help clinicians assess exam completeness during fetal ultrasound examinations. 

Yes. Measurements generated by the application can be reviewed and edited by the user at any time during the examination. Simply select the corresponding image and click the “Edit Measurement” button. In addition to editing measurements, you can customize the ratio limits to define which values are considered normal and which are considered out of range. 

Fetoly application supports clinicians by assisting with the assessment of cardiac views and ratio measurements during fetal ultrasound examinations. The cardiac conditions currently supported by the application are described in our White Paper.

Yes. Fetoly generates a structured examination report including the exam completeness score, recognized standard planes, and automatic ratio measurements. The report can be exported as a PDF or DICOM file and integrated into your PACS workflow. 

You don’t need to do anything. The app updates automatically via the Apple App Store or Google Play Store, ensuring you always have the latest features without manual installation or maintenance. 

We comfortably exceed regulatory standards across all performance metrics, delivering 96% sensitivity (correctly identifying relevant clinical features) and 99.5% specificity (correctly ruling out irrelevant elements). 

Nothing. Our application is designed to work in the background, without requiring any changes to your existing ultrasound workflow or scanning routine. 

No. The solution operates fully offline. Internet access is only required occasionally for license verification or software updates. 

No. Fetoly operates locally on the tablet. No cloud infrastructure is used, and no patient data is stored or accessed by Diagnoly.

Yes. Fetoly supports seamless PACS integration and DICOM export workflows. 

Yes. Fetoly is designed with privacy in mind. Because the AI runs directly on your device, your data stays on your device by default. Nothing is shared unless you explicitly choose to. 

Unlike AI solutions that rely on power-intensive external data centers, Fetoly processes data directly on your device. This local AI architecture consumes only the power required to run your tablet while eliminating the need for cloud computing during routine use. 

Yes. Our dedicated Customer Support team will guide you through the installation and onboarding process to ensure Fetoly is configured correctly and ready to use. Contact support@diagnoly.com 

Diagnoly provides more than AI technology. In addition to Fetoly, our real-time AI ultrasound assistant, we offer comprehensive onboarding, educational programs, clinical training, dedicated customer support, and ongoing product updates. We work closely with our Scientific Board, healthcare professionals, and OEM partners to continuously improve our AI using the latest scientific evidence, clinical feedback, and evolving prenatal ultrasound practices. This ensures our customers benefit from continuous innovation and long-term support. 

The development of Fetoly began in 2019, we have been CE-certified since 2023 and FDA-cleared since 2024. This means our software underwent years of rigorous testing and clinical validation prior to launch, ensuring highly reliable and trusted outcomes. 

Prior to every software release, we collaborate closely with our medical committee and partner OB-GYNs. This allows us to rigorously test the AI model in live clinical environments, ensuring it performs flawlessly in real-world scenarios.