Ceribell Status Epilepticus Monitor
Ceribell, Inc.The Ceribell Status Epilepticus Monitor is a software medical device that analyzes EEG data captured from a headband device to automatically detect electrographic status epilepticus in patients at risk of seizures. It provides timely diagnostic support to clinicians in acute care environments, enabling faster treatment decisions for this critical neurological condition.
Intended Use
The Ceribell Status Epilepticus Monitor is a software as medical device that is intended to analyze EEG recordings captured with the Ceribell Pocket EEG Device and the Ceribell Instant EEG Headband and diagnose electrographic status epilepticus in patients greater than or equal to 18 years of age who are at risk for seizure.
Technology
The device is software that analyzes EEG waveforms from a headband with 10 electrodes arranged in a bipolar montage to detect electrographic status epilepticus according to ACNS Guideline 14. It processes the EEG to make a binary determination of presence or absence of ESE.
Performance
Bench testing verified system integration and functional performance, with all tests passed. Clinical testing involved a retrospective study analyzing 350 EEG datasets from 6 hospitals, with expert neurologist review as ground truth. The software achieved 100% sensitivity and 94% specificity in detecting status epilepticus, indicating effective diagnostic performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/22/2022
6 months - 2
FDA Approval
5/23/2023
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