DA100-DASHBOARD

Dénomination commerciale

non renseigné

03770027067016

3770027067SAMD0126

Numéro de référence/catalogue

DA100-DASHBOARD

GS1

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 and a web portal. The mobile application is intended to be used by patients living with Multiple Sclerosis (MS) in their home environment, as an unsupervised self-assessment digital tool of various functional parameters. These parameters include walking perimeter, walking speed, hand function, low contrast visual acuity and cognitive processing time. The patient is not intended to take action on the device output without the consultation of a qualified Healthcare Professional (HCP). The assessment results are intended to be visualized on the web portal by healthcare professionals qualified to interpret the functional assessment results over time, for patient remote monitoring. MSCopilot is an adjunctive tool and is not intended to be used as a standalone diagnostic device nor to identify the presence or absence of clinical diagnoses. The healthcare professional benefit of MSCopilot is to track objective measures of key functional symptoms of the disease between consultations, supporting MS patients’ management. Another expected benefit is gain of healthcare time by providing a “big picture” of the patient's condition over time. Patients' clinical benefits rely on telemonitoring of functional tests analogous to modified Multiple Sclerosis Functional Composite, 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.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

2 avertissements enregistrés — faire défiler le panneau pour tout voir.

• Consulter un professionnel de la santé avant toute utilisation
• Consulter la notice d’utilisation