NeuroMatch
LVIS CorporationNeuroMatch is a cloud-based medical software developed by LVIS Corporation to assist neurologists in reviewing and analyzing EEG recordings by automatically detecting potential seizures and epileptiform spikes. It employs advanced AI algorithms to highlight important EEG events, helping clinicians interpret brain activity more efficiently without providing a direct diagnosis.
Intended Use
LVIS NeuroMatch Software is intended for review, monitoring and analysis of EEG recordings made by scalp electrodes to aid neurologists in EEG assessment. It marks previously acquired adult EEG sections that may correspond to electrographic seizures or spikes to assist assessment. It also calculates quantitative measures and displays physiologic signals like ECG if present.
Technology
NeuroMatch is a cloud-based SaMD that uses deep learning algorithms for artifact reduction, seizure detection, and spike detection on EEG data acquired with a full scalp 10-20 electrode montage. It calculates quantitative EEG measures (e.g. FFT spectrogram) and includes artifact reduction to reduce muscle/eye movement noise while preserving cerebral signals.
Performance
Performance testing included rigorous software verification and validation, cybersecurity assessments, and comprehensive clinical validation of seizure and spike detection using EEG datasets from multiple independent sites. Validation showed NeuroMatch met non-inferiority criteria versus the predicate device Persyst 14 with similar sensitivity and false detection rates for both seizure and spike detection, ensuring safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/15/2024
6 months - 2
FDA Approval
11/26/2024
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