Fetoly-AI Ultrasound Assistant
Diagnoly
Free · Designed for iPad. Not verified for macOS.
iPad
FETOLY by Diagnoly | Real-time AI ultrasound assistant for prenatal screening.
Intended purpose:
FETOLY is intended to analyze fetal ultrasound image sequences using machine learning techniques to automatically:
• Detect brain and heart views and quality criteria within the views;
• Detect images suitable for measuring biometric parameters of the fetal heart and brain and provide quantitative measurements of these parameters.
The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images.
FETOLY is indicated for use during routine fetal heart and brain examination of 2nd and 3rd trimester pregnancy (gestational age: from 17 to 40 weeks).
Designed for sonographers and OB/GYN physicians, our application helps healthcare professionals with four tasks:
• Completeness measurement: Displays in real time the fetal brain and heart views and quality criteria verified during the examination, which are immediately accessible to the user.
• Automatic measurement: Displays in real-time in which fetal brain and heart measurements are seen and done by the software during the examination, and if the measurements are in- or out-of-range. The verified heart and brain measurements are accessible to clinicians in real-time.
• Examination illustration: the software selects an image subset that illustrates the verified views and quality criteria. These images can be reviewed by clinicians to verify the views and criteria’s presence. Optionally, clinicians can display detected quality criteria localization on selected images. For each measurement, the software displays an image with the measurement drawn and the measured value. The normal range for this measurement is also reminded to the user.
• Examination report: The software allows the user to export an examination report which contains a summary of measurements and completeness and images with measurement drawn and value.
Operating instructions:
Please install the software on a compatible tablet (see below) and follow sections 12 and 13 of the eIFU for operating instructions.
FETOLY can be used only with a license provided by Diagnoly. This license is linked to the contract signed with the company.
The license needs internet connection to be validated. An internet connection will be asked at least each 30 days for update and license verification purpose.
Notice that FETOLY shall be configured before use. This configuration is related to ultrasound system connection, video stream input and export.
Related hardware:
FETOLY shall be installed on the tablet. Minimum requirements are found in section 10 of the e-IFU as follows:
• CPU architecture ARMv8
• A A14 or M1 processor
• At least 8GB of RAM capacity
• At least 1GB of storage capacity
• iOS in version 17 or higher
Please reach Diagnoly for any question on tablet choice.
FETOLY is compatible with the following video capture devices:
EU
https://tinyurl.com/2ea6b8m9
US
https://tinyurl.com/y6yfsswk
FETOLY is compatible with ultrasound systems from Samsung, GE and Canon.
Set-up and connection security:
Please refer to section 12 of the e-IFU for cybersecurity instructions.
Warning and precautions:
Please see section 10 of the e-IFU for warning and precautions. There is no major warning or contraindication linked to FETOLY.
e-IFU: https://diagnoly.com/fetoly-ifu.html
The Instructions For Use (IFU) can be ordered in paper format by contacting support@diagnoly.com.
FETOLY is manufactured by:
DIAGNOLY SAS (FR-MF-000037822)
Immeuble Terra Mundi, 2 Place de Francfort, 69003 LYON, France
Tel.: +33 (0)6 58 49 07 84
Product complaints: support@diagnoly.com
Please report any serious incident to Diagnoly through product complaints e-mail address and to the Competent Authority of your country.
UDI-DI: 3770033463055
Notified body number: 0197
Certificates number:
CE MDR: HZ 2527981-1
EN ISO 13485:2016: SX 2527981-1
Ratings & Reviews
- This app hasn’t received enough ratings or reviews to display an overview.
What's new:
- New interface design
- Display of live markers on the video stream
- Automatic ultrasound area and ratio detection
- Option to hide the mid-sagittal view if desired
- Annotated selected images in your PACS. They now include the patient's name, GA and view/landmarks
What's improved:
- Improved image selection: The reasons behind each selection are displayed
- Improved report
- Enhanced keypoint position through improved spatial smoothing
Bug Fixes
- See release note in About page
The developer, DIAGNOLY, indicated that the app’s privacy practices may include handling of data as described below. For more information, see the developer’s privacy policy .
Data Not Collected
The developer does not collect any data from this app.
Accessibility
The developer has not yet indicated which accessibility features this app supports. Learn More
Information
- Seller
- DIAGNOLY
- Size
- 228.4 MB
- Category
- Medical
- Compatibility
Requires iPadOS 18.0 or later.
- iPad
Requires iPadOS 18.0 or later. - Mac
Requires macOS 15.0 or later and a Mac with Apple M1 chip or later.
- iPad
- Languages
English and 6 more
- English, Danish, French, German, Norwegian Bokmål, Portuguese, Swedish
- Age Rating
16+
- 16+
- Frequent
Medical Treatment information
- Medical Device
Yes
- DIAGNOLY indicated this app is a regulated medical device and complies with United States law.
- The information below has not been verified by Apple.
- FDA Owner/Operator Number
- 3033557977
- Address
- 2 Place de Francfort
Immeuble Terra Mundi
69003 Lyon
France - Phone Number
- +33 6 58 49 07 84
- dev@diagnoly.com
- Use Statement
- FETOLY is intended to analyze fetal ultrasound image sequences using machine learning techniques to automatically:
- detect brain and heart views and quality criteria within the views;
- detect images suitable for measuring biometric parameters of the fetal heart and brain and provide quantitative measurements of these parameters.
The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images.
FETOLY is indicated for use during routine fetal heart and brain examination of 2nd and 3rd trimester pregnancy (gestational age: from 17 to 40 weeks). - Safety Information
- Warnings and precautions from risk management file:
• The user shall zoom in of at least 30% to avoid software false-negative;
• The user shall systematically review the images set 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;
• Incompatible video stream can lead to error in examination documentation. The video stream shall have the following characteristics:
◦ At least 24 frame per second (fps);
◦ A resolution inferior to 1280*720.
• Tablet incompatibility can lead to error in examination documentation;
• Export failure leads to examination report loss;
• Please verify the patient name chosen before DICOM export on the export page to avoid patient file mix-up;
• Use on 1st trimester pregnancy leads to error in completeness function;
• The examination shall be done on one foetus at a time;
• If the tablet starts to overheat, stop the use of the software;
• Please verify the battery level of your tablet before examination. Software shut-down can lead to examination data loss;
• The software cannot be used for screening purpose as it can lead to false negative screening contribution;
• Use the tablet alone and do not allow unauthorized person to access to your tablet to avoid security risks;
• Please be aware that when the data are exported on your device, they are under your responsibility;
• Do not use any other tablet application in parallel to FETOLY to avoid interference on the image stream reception process or machine learning calculation execution;
• Do not use the application while scanning with a transvaginal probe, as the product has not been tested with transvaginal images.
There is no contraindication linked to FETOLY device. - Instructions for Use
- Visit the developer site
- Copyright
- Diagnoly SAS Copyright © 2026