ETNA™-MS (under Health Canada review)
The Eye-Tracking Neurological Assessment for Multiple Sclerosis (ETNA™-MS) is a software as a medical device (SaMD) intended to administer a non-invasive test and provide an Expanded Disability Status Scale (EDSS) score in the range between 1.0 and 4.5 for use in tracking the disease progression in MS patients.ETNA™-MS is a 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 an MS 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 and basic patient information are then uploaded for offline analysis to ETNA™-Cloud.
- ETNA™-Cloud is a software application running offline on a company-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 (Classifier) to analyze the gaze and eye-movement metrics and patient information uploaded by the ETNA™-MS App at the end of a test session; it identifies relevant features that can best determine MS disease status and outputs an Expanded Disability Status Scale (EDSS) score for clinicians to consult.