Fetoly

Medicina

Gratis · Progettata per iPad

iPad

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). Our software helps healthcare professionals with four tasks: - Completeness measurement: Displays in real-time which fetal brain/heart views and quality criteria are verified by the software during the examination. The verified brain/heart views and quality criteria are accessible in real-time. - Automatic measurement: Displays in real-time 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 by 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. - each measurement. 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; - Illustrations (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: - iOS in version 17.5 or higher Please reach Diagnoly for any question on tablet choice. FETOLY is compatible with the following video capture devices: FR https://tinyurl.com/zr5p86yy US https://tinyurl.com/nn8943re 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) 60 avenue Rockefeller, 69008 LYON, France Tel.: +33(0)4.78.76.85.75 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: 3770033463031 Notified body number: 0197 Certificates number: CE MDR: HZ 2527981-1 EN ISO 13485:2016: SX 2527981-1

Valutazioni e recensioni

  • L’app non ha ricevuto un numero sufficiente di valutazioni o recensioni per poter mostrare una panoramica.

Lo sviluppatore, DIAGNOLY, ha indicato che le procedure per la tutela della privacy dell’app potrebbero includere il trattamento dei dati descritto di seguito. Per scoprire di più, consulta l’informativa sulla privacy dello sviluppatore .

  • Dati non raccolti

    Lo sviluppatore non raccoglie alcun dato da quest’app.

    Le procedure per la tutela della privacy potrebbero variare, ad esempio in base alle funzionalità che utilizzi o alla tua età. Scopri di più

    Accessibilità

    Lo sviluppatore non ha ancora indicato le funzioni di accessibilità supportate dall’app. Scopri di più

    Informazioni

    • Dimensioni
      • 91,2 MB
    • Categoria
      • Medicina
    • Compatibilità
      Richiede iPadOS 17.5 o versioni successive.
      • iPad
        Richiede iPadOS 17.5 o versioni successive.
      • Mac
        Richiede macOS 14.5 o versioni successive e un Mac con chip Apple M1 o versioni successive.
    • Lingue
      • Francese e Inglese
    • Età
      16+
    • Fornitore
      DIAGNOLY
      • DIAGNOLY si identificata come operatore commerciale per questa app e ha confermato che il prodotto o il servizio è conforme alla legge dell’Unione europea.
      • Numero DUNS
        274279654
      • Indirizzo
        IMMEUBLE LAENNEC
        60 AV ROCKEFELLER
        69008 LYON 8EME
        Francia
      • Numero di telefono
        +33 695870455
      • Email
        dev@diagnoly.com
    • Copyright
      • Diagnoly SAS Copyright © 2025
  • Sito web sviluppatore
  • Informativa sulla privacy