Ephion Mobility
Intended purpose
Ephion Mobility is a Medical Device Software (MDSW) intended to provide objective functional capacity information of 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), Pompe, Charcot-Marie-Tooth disease, Guillain-Barre Syndrome, Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), Anti-NF155 Nodopathy, Anti-Myelin-Associated-Glycoprotein Neuropathy (Anti-MAG), Multifocal Motor Neuropathy, Chronic Ataxic Neuropathy Ophthalmoplegia IgM paraprotein cold Agglutinins and Disialosyl antibodies (CANOMAD)). The software supports the assessment of functional capacity and clinical changes associated over time with disease progression and treatment response by generating global scores. 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
