Wird aktualisiert
Beschreibung
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:
FR
https://tinyurl.com/ymatth8a
US
https://tinyurl.com/3sr53un2
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: 3770033463048
Notified body number: 0197
Certificates number:
CE MDR: HZ 2527981-1
EN ISO 13485:2016: SX 2527981-1
Neue Funktionen von Version 2026.0225.1389
- Addition of PLAS (Post-Left Atrium Space), VP-ratio and CSP ratio measurements
- Merging of TransThalamic (TT) and TransVentricular (TV) views into simplified Axial view
- Improved AI model performances
- TLS mode added to DICOM export
- IFU translated into Spanish, Romanian, Czech, Slovak, Portuguese and Greek
- Software now available in Slovak and Portuguese
- CH REP reference added in About section
- Address updated
Anbieter
Name
DIAGNOLY
Informationen
Entwickler
Kategorien
Version
2026.0225.1389
Größe
126,2 MB
Game Center
Nein
VPP Device Licensing
Ja
Bewertung
Freigabe 17+ für Folgendes:
Häufig/stark ausgeprägt: medizinische/Behandlungs-Informationen
Kompatibilität
iOS 17.5 oder neuer
Geräte
iPad (5. Generation) Wi-Fi, iPad (5. Generation) Wi-Fi + Cellular, iPad (6. Generation) Wi-Fi, iPad (6. Generation) Wi-Fi + Cellular, iPad Pro, iPad Pro (Cellular), iPad Pro (9,7 Zoll), iPad Pro (9,7 Zoll) (Cellular), iPad Pro (12,9", 2. Generation), iPad Pro (12,9", 2. Generation) Wi-Fi + Cellular, iPad Pro (10,5"), iPad Pro (10,5") Wi-Fi + Cellular, iPad Pro (11"), iPad Pro (11") Wi-Fi + Cellular, iPad Pro (12,9", 3. Generation), iPad Pro (12,9", 3. Generation) Wi-Fi + Cellular, iPad Air, iPad Air (Cellular), iPad Air 2, iPad Air 2 (Cellular), iPad Air (3. Generation), iPad Air (3. Generation) Wi-Fi + Cellular, iPad mini Retina, iPad mini Retina (Cellular), iPad mini 3, iPad mini 3 (Cellular), iPad mini 4, iPad mini 4 (Cellular), iPad mini (5. Generation), iPad mini (5. Generation) Wi-Fi + Cellular, iPad (7. Generation) Wi-Fi + Cellular, iPad Pro 11" (2. Generation), iPad Pro 11" (2. Generation) Wi-Fi + Cellular, iPad Pro 12,9" (4. Generation), iPad Pro 12,9" (4. Generation) Wi-Fi + Cellular, iPad Air (4. Generation) (Wi-Fi), iPad Air (4. Generation) (Wi-Fi + Cellular), iPad (8. Generation) Wi-Fi, iPad (8. Generation) Wi-Fi + Cellular, iPad Pro 11" (3. Generation), iPad Pro 11" (3. Generation) Wi-Fi + Cellular, iPad Pro 12,9" (5. Generation), iPad Pro 12,9" (5. Generation) Wi-Fi + Cellular, iPad (9. Generation), iPad (9. Generation) Wi-Fi + Cellular, iPad mini (6. Generation), iPad mini (6. Generation) Wi-Fi + Cellular, iPad Air (5. Generation), iPad Air (5. Generation) Wi-Fi + Cellular, iPad Pro 11" (4. Generation), iPad Pro 11" (4. Generation) Wi-Fi + Cellular, iPad Pro (12,9", 6. Generation), iPad Pro (12,9", 6. Generation) Wi-Fi + Cellular, iPad (10. Generation), iPad (10. Generation) Wi-Fi + Cellular, iPad Air (11″, M2, Wi-Fi), iPad Air (13″, M2, Wi-Fi), iPad Air (13″, M2, Wi-Fi + Cellular), iPad Pro (11″, M4, Wi-Fi), iPad Pro (11″, M4, Wi-Fi + Cellular), iPad Pro (13″, M4, Wi-Fi), iPad Pro (13″, M4, Wi-Fi + Cellular), iPad mini (A17 Pro) Wi-Fi, iPad mini (A17 Pro) Wi-Fi + Cellular, iPad (A16) Wi-Fi, iPad (A16) Wi-Fi + Cellular, iPad Air 11" (M3) Wi-Fi, iPad Air 11" (M3) Wi-Fi + Cellular, iPad Air 13" (M3) Wi-Fi, iPad Air 13" (M3) Wi-Fi + Cellular, iPad Pro (11″, M5, Wi-Fi), iPad Pro (11″, M5, Wi-Fi + Cellular), iPad Pro (13″, M5, Wi-Fi), iPad Pro (13″, M5, Wi-Fi + Cellular), iPad Air11M4, iPad Air11M4Cellular, iPad Air13M4, iPad Air13M4Cellular
Sprachen
Englisch, Französisch, Portugiesisch, Slowakisch
App Store: Kundenbewertungen
Bewertungen & Rezensionen
0,0 von 5 (Keine Bewertung)
App Store: Kundenrezensionen
Kein Eintrag