ETNA for MS was granted Breakthrough Device status by the FDA in May 2022. The proposed indication of use includes: “The Eye-Tracking Neurological Assessment for Multiple Sclerosis (ETNA™ for MS) is intended to record eye movements for use in estimating disease severity in Multiple Sclerosis (MS) patients, which will aid clinicians to track disease progression. The intended patient population are all individuals having already received a diagnosis of MS, irrespective of MS subtype (relapsing-remitting (RRMS), secondary- progressive (SPMS), primary-progressive (PPMS), and progressive-relapsing (PRMS)), who present with oculomotor symptoms or signs.”

Resolves YES if the FDA clears ETNA for MS by December 1, 2023.