HippoMind (v1.0)

HippoMind (v1.0) is a cloud-based software platform that displays neuroimaging and neurosignaling data (MRI, CT, PET, SPECT, EEG, and MEG) for review by qualified healthcare professionals. It provides tools for analysis, annotation, storage, transfer, and association of data with electronic health records, intended to support clinical decision-making in neurology and neurodiagnostics without providing diagnostic conclusions.

HippoMind is a web-based software platform with client-side browser rendering and backend data services (no hardware). For EEG/MEG: it displays waveforms with adjustable gain/sensitivity, per-channel bandpass and notch filtering, manual annotations (lines, boxes, text labels for spikes/seizures), and synchronized video—but lacks automatic event detection. For neuroimaging: it supports MRI, CT, PET, SPECT in DICOM or NiFTI formats with 3D rendering, window/level adjustment, multi-planar reformatting, and overlay capabilities using affine transformation.

Not stated in this summary.

HippoMind is substantially equivalent to three predicates: Natus NeuroWorks (K200878) for EEG review, CTF Whole-Cortex MEG System (K030737) for MEG review, and eUnity (K172490) for neuroimaging review. All are Class II devices under 21 CFR 882.1400 or 892.2050 intended for qualified professionals to review pre-acquired data without providing diagnostic conclusions. Clinical validation showed 100% agreement among three experienced clinicians on signal quality, interpretability, and image quality across 30 EEG and 20 MEG recordings and 61 imaging studies, demonstrating equivalent performance to predicates in review-mode functionality.