ETNA™-MS is a Health Canada-approved Software as a Medical Device (SaMD Class II; License #110953), intended to administer a non-invasive test that allows clinicians to track eye-movement metrics in adult patients and to provide an Expanded Disability Status Scale (EDSS) score in the range between 1.0 and 7.0 and a Symbol Digit Modalities Test (SDMT) score –a measure of cognitive processing speed– for use in tracking disease progression and cognitive function in MS patients.
ETNA™-MS includes the ETNA™-MS App and ETNA™-Cloud, which is a SaMD intended to be used by healthcare providers (HCPs) and their adult patients who have already received a diagnosis of MS, irrespective of MS subtype (relapsing-remitting (RRMS), secondary-progressive (SPMS), primary-progressive (PPMS), and progressive-relapsing (PRMS)). ETNA™-MS is intended to assist patients in managing their MS with guidance from their providers. ETNA™-MS should not be used by individuals with non-MS related walking impairments (e.g., gait disorders, leg/foot injuries) as this could lead to erroneous EDSS score estimates because the time needed to complete the Timed 25-foot Walk (T25-FW) test is an input for ETNA™-MS. Visit ETNA™-MS for full labeling information.
ETNA™-MS and ETNA™-Cloud are not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Seek the guidance of your treating physician or a licensed healthcare professional before making medical decisions.
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