Neurology, development and sleep: what the evidence shows
Software that flags seizures on EEG, scores sleep studies and aids autism diagnosis in young children, producing results for neurologists, sleep physicians and pediatric clinicians to review.
These tools analyze EEG, sleep study signals or developmental assessments: limited-montage EEG with automated seizure burden estimates, seizure detection software for conventional EEG, automated scoring of sleep studies and an aid for diagnosing autism in young children. FDA cleared the EEG seizure detection software and the sleep study scoring software reviewed here as automatic event detection software under 21 CFR 882.1400; the labeling of Ceribell's status epilepticus software says it does not substitute for a qualified clinician's review of the EEG for other abnormal patterns. Autism diagnosis aids got their own device classification when FDA granted Cognoa's De Novo request on June 2, 2021.
Most of the evidence measures agreement with expert review, and experts themselves disagree: in 120 epilepsy monitoring unit recordings, pairwise sensitivities among three experts ranged from 72.5% to 84.9%. In 7,924 critical care EEG records, one widely used detector had a record-level positive predictive value of 0.08. The American Academy of Sleep Medicine's artificial intelligence committee has said caution must be applied when using AI. Open questions include whether faster seizure detection improves neurological outcomes, which no randomized trial of these products has tested.
The tools reviewed in this category
General information, not medical advice. Every fact links to its source, and the page shows the date it was last reviewed.