ETNA-MS

ETNA™-MS is a Class II Software as a Medical Device (SaMD) comprising two components that operate as a software system:

• ETNA™-MS App is a visual stimulation, video recording and data collection App running on an off-the-shelf electronic tablet (iPad Pro). The App guides a patient to perform a test comprising distinct oculomotor (visual) tasks that require the patient to either follow, track, or respond to visual targets on the screen. Using the tablet’s embedded front camera, the App captures facial images of the patient performing those tasks and analyzes the images to extract several gaze and eye-movement metrics. The test data is then uploaded for analysis to ETNA™-Cloud.
  
  

• ETNA™-Cloud is a software application running on an Innodem-controlled server that is ISO/IEC 27001, PIPEDA and HIPAA compliant. It is intended for use by healthcare providers only. The software uses a clinically validated and locked AI Machine Learning model to analyze eye-movement metrics in combination with patient information (age, mobility level, T25-FW) uploaded by the ETNA™-MS App; the combination of this data on ETNA™-Cloud ultimately produces an Expanded Disability Status Scale (EDSS) score and a Symbol Digit Modalities Test (SDMT) score –a measure of cognitive processing speed– that allow clinicians to better determine the state of the disease and follow its progress.