Device Tracker
FDA-Cleared AI Devices in Neurology
Brain imaging quantification, EEG interpretation, and neurological triage.
| 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) | 2018 onward | EEG | Detects seizure burden on rapid-response EEG |
| icobrain | icometrix | 510(k) | 2016 onward | Brain MRI and CT | Quantifies brain volumes and lesion burden |
| Persyst EEG Analysis | Persyst | 510(k) | Multiple clearances | EEG | Automated seizure and spike detection in EEG |