FDA-Cleared AI Device

Ceribell Clarity

Ceribell

Pairs a rapid-deployment headband EEG with algorithmic analysis that reports seizure burden, aimed at settings without immediate access to an electroencephalographer.

At A Glance

Manufacturer
Ceribell
Medical specialty
Neurology
Clearance route
510(k)
Year authorized
2018 onward
Modality
EEG
Role in workflow
Triage and notification

Non-convulsive status epilepticus is a condition where the diagnosis requires EEG and the treatment window is short, and most hospitals cannot obtain an EEG at three in the morning. The system attacks availability rather than interpretation, which is the actual bottleneck.

Where It Is Used

  • Non-convulsive status epilepticus assessment in emergency settings
  • Rapid EEG where no technologist is available
  • Community hospital neurological emergencies

Limitations Worth Knowing

Reduced-electrode montages capture less than full clinical EEG and can miss focal activity. The output supports a clinical decision and does not replace formal EEG interpretation where that is available.

Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.

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