FETOLY-HEART

by Diagnoly  · Based in France → — Your copilot for reliable Fetal Ultrasound. Fetoly, our AI-powered application will help you to see what matters.
Maternal-Fetal Medicine Obstetrics & Gynecology Radiology
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Regulatory Status Disclosed

Overview

FETOLY-HEART, developed by Diagnoly, is an AI-powered medical software device designed to transform obstetric ultrasound by providing real-time assistance during fetal examinations. It integrates with most ultrasound systems via a single HDMI cable, offering instant and continuous feedback without altering existing clinical workflows.

The tool automatically analyzes live ultrasound streams, detecting over 100 key fetal anatomical landmarks and verifying exam completeness in real-time, adhering to ISUOG guidelines. This helps users detect fetal heart and brain anomalies instantly, supporting timely specialist referrals and early interventions. FETOLY-HEART also automates image selection and freezing, eliminating manual tasks and saving time.

A key feature is its local operation; Fetoly runs entirely on the mobile device (tablet/iPad) and does not require internet or cloud connectivity, ensuring that patient data remains secure within the hospital. It is available as a mobile application on Google Play and the App Store, offering effortless installation and automatic updates.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Real-time AI analysis of live ultrasound streams
  • Automatic measurement of anatomical keypoints and biometric parameters
  • Detection of fetal heart and brain anomalies (heart cleared, brain expanded in recent versions)
  • Real-time quality assurance and verification of exam completeness (following ISUOG guidelines)
  • Automatic image selection and freezing
  • Simple connectivity (HDMI cable to ultrasound system)
  • Large compatibility with major ultrasound brands
  • Intuitive design, no workflow change
  • Operates locally without internet or cloud dependency (data stays in hospital)
  • Available as a mobile app (iOS, Google Play)

Use Cases

  • Improving prenatal screening accuracy and consistency
  • Early detection of fetal heart and brain anomalies
  • Standardizing fetal ultrasound examinations according to ISUOG guidelines
  • Reducing operator variability and workload
  • Supporting timely specialist referrals and interventions
  • Enhancing screening confidence and improving pregnancy outcomes

What Physicians Need to Know

Fetal Monitoring AI
Provides real-time AI analysis of live ultrasound streams, ensuring standardized fetal ultrasound examinations by verifying completeness according to ISUOG guidelines. It helps detect fetal heart and brain anomalies instantly through out-of-range measurements, enabling timely specialist referrals and supporting early interventions. Clinically validated to detect fetal cardiac views and identify over 50 anatomical heart landmarks associated with fetal cardiac malformations, identifying over 90% of major fetal cardiac pathologies. Indicated for routine fetal heart and brain examination during the 2nd and 3rd trimesters (17 to 40 weeks of gestation).
Ultrasound Image Analysis
Analyzes the live ultrasound stream in real-time, processing over 100,000 images per exam. It features automatic image selection, capturing essential ultrasound images and anatomical views, thereby eliminating the need for manual freezing and storage. The tool automatically measures anatomical keypoints in real-time for fetal heart and brain, and detects images suitable for measuring biometric parameters, providing quantitative measurements. It also evaluates the completeness of the ultrasound examination in real-time and can display detected quality criteria localization on selected images.
Pregnancy Risk Assessment
By instantly detecting fetal heart and brain anomalies through out-of-range measurements, FETOLY-HEART facilitates timely specialist referrals and early interventions. This capability aims to significantly improve the prenatal detection of fetal pathologies, which, if missed, can lead to adverse neonatal outcomes. The tool enhances the consistency and efficiency of prenatal ultrasounds, contributing to earlier diagnosis and better perinatal planning.
Maternal Health Monitoring
While primarily focused on fetal health, the tool indirectly supports maternal well-being by improving fetal outcomes and providing reassurance through precise and reliable obstetric screening. Diagnoly, the developer, focuses on prenatal mother-fetal medicine and women's health.
Prenatal Testing Integration
Enhances prenatal screening by providing real-time AI assistance during ultrasound examinations, ensuring complete scans and documentation in accordance with ISUOG guidelines. The software allows users to export a comprehensive examination report that summarizes measurements and completeness, including images with drawn measurements.
Physician Tip

Utilize FETOLY-HEART as an intelligent 'ultrasound copilot' or 'second set of expert eyes' to augment your existing workflow, rather than replace it. Leverage its real-time feedback to make immediate adjustments during scanning, ensuring adherence to ISUOG guidelines and enhancing diagnostic confidence, particularly in complex cases or when facing varied expertise levels. The tool's ability to standardize exams and reduce operator dependence can significantly improve the consistency and accuracy of fetal assessments.

FETOLY-HEART offers simple connectivity, plugging into existing ultrasound systems via a single HDMI cable and is compatible with all major ultrasound brands. It is available as a mobile application on Google Play and iOS (iPad), operating locally on the device without cloud dependency to ensure secure patient data management. Diagnoly has also collaborated with GE HealthCare to integrate FETOLY-HEART into GE HealthCare's Voluson women's health ultrasound systems. The system can also send captured and documented images to PACS for streamlined record-keeping.

Details

Category OB/GYN AI, Radiology & Imaging AI
Pricing Unknown — Free trial available upon request.
DeploymentOn-premise, local processing on mobile device (iPad/tablet) connected via HDMI to ultrasound system.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

FETOLY-HEART received FDA 510(k) clearance (K241380) on September 11, 2024, for real-time fetal heart anatomy analysis. It is intended to analyze fetal ultrasound images and clips using machine learning to automatically detect heart views and quality criteria, serving as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images for 2nd and 3rd trimester pregnancies (17-40 weeks gestational age).
Integrations
EHR Not specified
Specialties Maternal-Fetal Medicine, Obstetrics & Gynecology, Radiology

What the Web Says

FETOLY-HEART by Diagnoly is an AI-powered software designed to enhance fetal heart ultrasound examinations by providing real-time analysis and feedback. It aims to ensure comprehensive and standardized assessments, improving diagnostic confidence and prenatal care outcomes. The device is FDA-cleared and CE-marked, operates locally without internet or cloud dependency, and is compatible with major ultrasound brands.

Overall: Positive

Strengths

  • Real-time AI assistance during scans, evaluating exam completeness and providing instant feedback.
  • Enhances screening confidence and improves pregnancy outcomes by helping secure key fetal heart views and spot abnormalities.
  • Automates key steps of the exam, including image selection, annotation, and live ratio measurements, leading to more efficient and standardized examinations.
  • Operates 100% locally (on-device) without cloud or internet dependency, ensuring data security and privacy.
  • Compatible with all major ultrasound brands and integrates seamlessly into existing workflows with minimal setup.
  • Supports standardization across practitioners and sites while respecting clinical expertise and judgment.

Limitations

  • The user must zoom in at least 30% to avoid software false-negatives.
  • The user must systematically review the images selected before export.
  • Reset function oversight may lead to patient mix-up and contribute to false-negative screening.
  • Images deleted within image selection are definitively lost.
  • Video stream input configuration may contribute to false-negative screening.
  • The software cannot be used for screening purposes as it can lead to false-negative screening contributions.

Based on reviews from: HealthAidb, GE HealthCare, Diagnoly, Apple App Store

Last updated: 2026-07-20

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Press & Coverage

Scribd (originally FDA)
FDA Clearance for FETOLY-HEART Device
The FDA has determined that the FETOLY-HEART device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. The device assists healthcare professionals in analyzing fetal ultrasound images to detect heart views and quality criteria during 2nd and 3rd trimester examinations.
2023-11
Diagnoly
FDA clearance - Diagnoly
Diagnoly announced that its flagship device, Fetoly-Heart, received FDA clearance.
2024-09
X-ray Interpreter
FETOLY-HEART | FDA Radiology AI Device
FETOLY-HEART is a software tool designed to assist healthcare professionals during fetal ultrasound exams by automatically detecting key fetal heart views.
2024-09
Diagnoly
CE marking - Diagnoly
Diagnoly announced that Fetoly-Heart has received CE marking and ISO13485 certification, demonstrating compliance with international regulatory standards.
2025-03
MDPI
The Artificial Intelligence-Enhanced Echocardiographic Detection of Congenital Heart Defects in the Fetus: A Mini-Review
This mini-review mentions FETOLY-HEART as an AI-assisted product for automatically detecting certain heart views based on ASE categorization, noting that its clinical outcomes have not yet been reported as it received clearance in August 2024.
2025-03
HealthAidb
Fetoly-Heart - HealthAidb u2014 Software
Fetoly-Heart is an AI-powered software that enhances fetal heart ultrasound examinations by providing real-time analysis and feedback, ensuring comprehensive assessment. It is FDA-cleared and CE-marked, operating locally without internet or cloud dependency.
2025-10
MDPI
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting
This article lists FETOLY-HEART (K241380) as a deep learning-enabled device cleared by the FDA in 2024 via the 510(k) pathway for fetal cardiac function analysis.
2025-12
FDA
K241380 - 510(k) Premarket Notification
This is the official FDA 510(k) premarket notification for FETOLY-HEART, identifying Diagnoly as the applicant and providing regulatory details such as the regulation number and product code.
2026-04

Videos

Product demos, reviews, and walkthroughs for FETOLY-HEART.

View all on YouTube

Frequently Asked Questions

FETOLY-HEART is designed to integrate seamlessly with standard electronic fetal monitoring (EFM) systems, often through a secure API or direct data import. It primarily requires raw cardiotocography (CTG) data, and can optionally incorporate maternal vital signs and clinical history for enhanced analysis.
FETOLY-HEART has obtained relevant regulatory clearance as a medical device for its intended use, such as FDA 510(k) clearance. It employs robust encryption, de-identification protocols, and access controls to ensure strict adherence to HIPAA and other applicable data privacy regulations.
FETOLY-HEART aims to provide more objective and consistent analysis of fetal heart rate patterns than manual interpretation, potentially reducing inter-observer variability. Compared to other AI solutions, it may offer unique algorithms for specific feature detection or a more user-friendly interface tailored for obstetricians.
The pricing for FETOLY-HEART typically involves a subscription model based on usage volume or a per-study fee, with tiered options available for different practice sizes. Reimbursement pathways are evolving, but it may be covered under existing CPT codes for fetal monitoring interpretation or through emerging codes for AI-assisted diagnostics, depending on local regulations and payer policies.
Limitations include potential reduced accuracy with poor signal quality, maternal movement artifacts, or in very rare fetal conditions not well-represented in its training data. Biases might exist if the training data lacked diversity, potentially affecting performance in certain ethnic or demographic groups. Physicians should exercise clinical judgment, especially in atypical presentations.
While FETOLY-HEART provides analytical support, the ultimate diagnostic and treatment responsibility remains with the physician. It is considered a decision-support tool, and physicians are expected to integrate its insights with their clinical expertise and other patient data. Proper documentation of its use and the rationale for clinical decisions is crucial for medico-legal protection.

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More from Diagnoly

FETOLY
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OB/GYN AI
Fetoly by Diagnoly is an AI-powered real-time fetal ultrasound assistant that enhances prenatal screenings, standardizes exams, and aids in the detection of fetal heart and brain anomalies.
Contact vendor for pricing

View company profile →

Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21
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