encevis (2.1)
AIT Austrian Institute of Technology GmbHEncevis (2.1) is a software tool that assists neurologists by automatically analyzing EEG recordings to detect seizures, spikes, electrographic status epilepticus, and other brain activity patterns. It reduces artifacts in EEG data, provides quantitative measures like frequency bands and burst suppression, and displays alerts to support rapid clinical decision-making, especially in acute care settings.
Intended Use
Encevis is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG including seizure detection, spike detection, quantitative EEG measures, and status epilepticus detection in adult patients.
Technology
Encevis is an integrated EEG analysis software package that operates both online (real-time streaming from EEG devices) and offline (analysis of stored EEG files), using algorithms for seizure and spike detection, artifact reduction, quantitative EEG analyses including frequency bands, rhythmic and periodic patterns, burst suppression, spectrograms, and aEEG trends. It supports output notifications via GUI and external interfaces.
Performance
Extensive non-clinical and clinical performance testing was conducted including blinded expert annotation comparisons, statistical testing for seizure detection, spike detection, artifact reduction, rhythmic pattern detection, aEEG, frequency band analysis and burst suppression detection. Results demonstrate high sensitivity and specificity, non-inferiority or superiority to predicate devices such as Persyst 12 and Ceribell products, supporting the device's safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/11/2024
5 months - 2
FDA Approval
9/27/2024
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