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Intended Use

NeuroMatch is intended for the review, monitoring, and analysis of EEG recordings from scalp electrodes in patients 18 years or older to assist qualified medical practitioners in assessing EEG. It includes seizure and spike detection and displays quantitative EEG measures and physiological signals such as ECG if provided. It visualizes brain activity by source localization on a 3D idealized model and shows trends over time, without providing diagnostic conclusions.

Technology

NeuroMatch is a SaMD that analyzes adult EEG data following the International Standard 10-20 electrode placement. It performs artifact reduction, seizure and spike detection, and source localization using sLORETA on an idealized head model. It displays three source localization trends (Maximum Amplitude Projection, Node Visit Frequency, Node Transition Frequency) as 3D visualizations to assist clinicians. The device is cloud-based and compares favorably to predicate devices like Epilog PreOp and CURRY (K172858 and K001781).

Performance

Performance testing included clinical validation of the source localization algorithm (sLORETA) across three independent datasets with 43 patients. NeuroMatch demonstrated non-inferiority compared to the CURRY reference device with a 90.7% concordance rate and comparable success rates across genders and age groups. Trends calculations were validated through software tests and clinical surveys confirmed acceptance and utility of trend displays. Overall, testing supports safety and effectiveness comparable to predicate devices.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    1/27/2025

    3 months
  • 2

    FDA Approval

    5/23/2025

Other devices from LVIS Corporation

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