Ephion Mobility
Intended purpose
Ephion Mobility is a Medical Device Software (MDSW) intended to provide an objective indicator of functional capacity for ambulant patients with health conditions in which mobility, stance, gait or balance are potentially affected by neurological, neuromuscular or musculoskeletal disorders (Duchenne Muscular Dystrophy (DMD), Becker Muscular Dystrophy (BMD), Myotonic Muscular Dystrophy (MMD), Late-Onset Pompe Disease (LOPD), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Anti-Myelin-Associated-Glycoprotein Neuropathy (AntiMAG)). The software processes biomechanical input data (spatio-temporal, cardiorespiratory and kinematic) collected from external wearable sensors to generate relevant features and a global score. These outputs support the objective assessment of functional capacity and clinical changes over time associated with disease progression and treatment response. The software is intended to be used by Healthcare Professionals (HCPs) involved in mobility-related clinical assessments, such as neurologists, physiotherapists, rehabilitators or nurses, among others. The software is intended to be used in clinical environments, including hospitals and rehabilitation centres.
Intended users
Ephion Mobility is intended to be used by Health Care Professionals (HCP), such as neurologists, rehabilitators, nurses or physiotherapists, among others. Is not intended for use by lay persons and therefore does not address the circumstances under which the user should consult a HCP.
Claims
- Ephion Mobility provides objective functional capacity information of patients and detects changes over time.
- Ephion Mobility detects patterns of movement that can be used to objectively monitor disease progression and assess treatment response.
- Ephion Mobility provides clinical decision support to healthcare practitioners treating patients.
Clinical benefits
- Monitoring of disease severity evolution
- Higher sensitivity at detecting clinical worsening
- Reduced sample sizes for detecting clinically meaningful differences
- Efficient assessment with shorter functional test
