FDA-Authorized AI Devices in Neurology
Compare neurology AI by acquisition method, clinical job, output, and who must review the result.
Neurology AI devices solve different problems. Some help a specialist review a full EEG recording. Others make rapid bedside EEG available when a conventional study cannot begin quickly.
Choose the clinical job and acquisition method first. Seizure detection, seizure burden, image quantification, and triage are not interchangeable outputs.
| Device | Manufacturer | Route | Year | Modality | Function |
|---|---|---|---|---|---|
| BrainScope One | BrainScope | 510(k) | 2016 onward | EEG | Assesses likelihood of structural brain injury after head trauma |
| Ceribell Clarity | Ceribell | 510(k) | 2023 | EEG | Monitors point-of-care EEG and alerts on sustained seizure activity |
| icobrain | icometrix | 510(k) | 2016 onward | Brain MRI and CT | Quantifies brain volumes and lesion burden |
| Persyst 15 EEG Review and Analysis | Persyst | 510(k) | Multiple clearances | EEG | Automated seizure and spike detection in EEG |
Choose The EEG Workflow
- For full clinical EEG review: Persyst 15 adds seizure and spike detection, trends, artifact reduction, and review tools to recordings from compatible EEG systems.
- For rapid bedside monitoring: Ceribell Clarity works with the Ceribell point-of-care EEG system to watch for sustained seizure activity and report seizure burden.
- For the output: separate an alert, a trend, a burden estimate, and a final interpretation. Each answers a different clinical question.
- For the handoff: define who reviews the result, how quickly they respond, and what happens when the system cannot provide an answer.
Rapid EEG And Full EEG Are Different Tools
Rapid point-of-care EEG can shorten the wait for initial brain monitoring. Full clinical EEG provides broader electrode coverage and supports formal interpretation. A hospital may need both rather than treating one as a replacement for the other.
Verify The Current Record
Use this directory to understand each device's job. Then confirm its current authorization and intended use in the FDA's AI-Enabled Medical Device List and the manufacturer's instructions for use.