DA100-ANDROID

Nom de l'organisation

Ad Scientiam

SRN

FR-MF-000017145

Statut du fabricant

Actif

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• CW030

  EUDAMED n'a pas publié de description pour ce code.
• CW010

  EUDAMED n'a pas publié de description pour ce code.

Marché principal en France ; disponible dans 1 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

03770027067009

Basic UDI-DI

3770027067SAMD0126

Numéro de référence/catalogue

DA100-ANDROID

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

MSCopilot is a software as a medical device consisting of a mobile application running on smartphones, a cloud computing platform and a web portal. The mobile application is intended to be used by people living with Multiple Sclerosis (PwMS) in their home environment. The application is used for data collection through unsupervised functional tests and electronic questionnaires. The functional tests assess walking perimeter, walking speed, hand function, low contrast visual acuity and cognitive processing time. The e-questionnaires assess fatigue and depression. Results are not intended to be interpreted by the patients themselves. The cloud computing platform is intended to retrieve and process automatically the data collected from the mobile application. These collected data are intended to be processed into digital biomarkers and stored on the remote medical device cloud platform. The web portal is intended to display the digital biomarkers results to qualified healthcare professionals. It enables them to track, between consultations, objective measures of key symptoms, to have an overview of the patient’s parameters over time and supports their care management. MSCopilot is an adjunctive tool to the standard clinical care and is not intended to be used as a standalone diagnostic device nor to identify the presence or absence of clinical diagnoses. The main benefit of MSCopilot is to track objective measures of these key symptoms between consultations to improve MS patients’ management by their healthcare professionals. Patients' clinical benefits rely on telemonitoring of functional tests analogous to modified MSFC, giving them access to a non-routinely clinical test that covers dimensions not taken into account with routine clinical tests (EDSS).

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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