Neurology AI medical devices

A neutral, evidence-based catalogue of neurology AI medical devices. No manufacturer pricing, no buy links — just regulatory facts and clinical capability summaries.

Neurology

Onera SleepMap

Onera B.V.

FDA

Software-only, cloud-hosted scoring service for polysomnography recordings made with the Onera Sleep Test System (STS I), a patch-based type II sleep recorder. A deep-learning model stages sleep from EEG, EOG and EMG; a convolutional network flags arousals; rule-based detectors mark desaturations, obstructive apnoeas and hypopnoeas, leg movements and signal artefacts. Central and mixed events, RERAs, Cheyne-Stokes breathing, snoring and arrhythmias are not detected and must be scored by hand. Every automated annotation is subject to review by a qualified clinician before it enters the sleep report.

Neurology

NeuroQuant

Cortechs.ai (formerly CorTechs Labs, Inc.)

CEFDAHC

Software that automatically labels, visualises and volumetrically quantifies segmentable brain structures from a routine 3D T1-weighted brain MRI, comparing each measured volume against an age- and sex-matched normative reference range and — where a prior study exists — tracking change over time. It is used as a supplemental measurement aid across dementia and Alzheimer's disease (hippocampal and whole-brain atrophy), epilepsy (hippocampal asymmetry in mesial temporal sclerosis), multiple sclerosis and traumatic brain injury. The most recent release, NeuroQuant 5.0, adds segmentation and quantification of susceptibility- and T2*GRE-based lesions, including microhaemorrhages and the amyloid-related imaging abnormalities (ARIA-E and ARIA-H) monitored in patients on anti-amyloid Alzheimer's therapy. Every module is a concurrent reading aid: it produces a quantitative report alongside the radiologist's interpretation and does not itself issue a diagnosis.

Neurology

JLK-NCCT

JLK, Inc.

FDA

Triage-and-notification software for non-contrast head CT in suspected stroke. It runs on a JLK server in parallel with the normal read, flags studies with findings suggestive of intracranial haemorrhage or of a large vessel occlusion of the internal carotid artery or the M1 or M2 segments of the middle cerebral artery, and pushes a mobile notification with a compressed preview image so the right specialist looks first. It does not mark the image, does not rule anything out, and does not replace CT angiography.

Neurology

icobrain

icometrix (a GE HealthCare company)

CEFDA

A family of quantitative brain-imaging modules that automatically segment and measure clinically relevant brain structures and lesions from routine DICOM studies — whole-brain, hippocampal and ventricular volumes and longitudinal change on MRI for dementia, multiple sclerosis and epilepsy; hyperdense haemorrhage volume, cisternal compression and midline shift on non-contrast head CT for traumatic brain injury; and perfusion mapping on CT perfusion. A separate cleared module, icobrain aria, is a computer-aided detection and diagnosis tool that detects, measures and grades amyloid-related imaging abnormalities (ARIA-E and ARIA-H) in patients on amyloid-targeting Alzheimer's therapies. Every module is a concurrent reading aid, not an autonomous reader.

Neurology

qER

Qure.ai

CEFDAHC

Deep-learning triage software for non-contrast adult head CT. The US-cleared qER configuration analyses scans in the background and raises a case-level worklist flag for suspected intracranial haemorrhage, mass effect, midline shift and cranial fracture; a sibling clearance (qER-Quant) adds quantitative brain-structure measurement, and a 2025 clearance (qER-CTA) extends triage to suspected large-vessel occlusion on CT angiography. The triage device is notification-only: it does not mark the image or render a diagnosis.

Neurology

EarliPoint Assessment

EarliTec Diagnostics, Inc.

FDA

Eye-tracking-based assessment that measures a child's moment-by-moment visual attention to social information — where they look, and when — while they watch short video scenes of everyday childhood interaction. The system samples gaze position continuously, compares the child's looking behaviour against age-expected reference norms of social visual engagement, and returns objective indices that aid qualified clinicians in the diagnosis and assessment of autism spectrum disorder in children aged 16 through 95 months. It grew out of two decades of eye-tracking research at the Marcus Autism Center and Emory University, and its 510(k) lineage runs from the first clearance in 2022 (ages 16 to 30 months) through the March 2026 clearance (K253442) that extended the indication to 31 through 95 months — roughly age eight.

Neurology

Ceribell Delirium Monitor System

Ceribell, Inc.

FDA

Software that continuously analyses discrete segments of electroencephalogram signal for features associated with diffuse slowing — patterns that may be indicative of delirium — and notifies clinicians when they are detected. It runs on Ceribell's point-of-care EEG platform, a rapidly applied headband and portable recorder already deployed in emergency departments and intensive care units, and is intended to aid the screening and monitoring of delirium alongside clinical assessment in adult critical-care patients. Ceribell describes it as the first device the FDA has cleared for delirium screening and monitoring; its primary predicate, Prolira's DeltaScan Monitor (K222680), is cleared under the same product code as an EEG aid to the diagnosis of acute encephalopathy in adults over 60 — the distinction is in the labelled wording, delirium versus encephalopathy.

Neurology

e-Stroke Suite

Brainomix

CEFDA

AI imaging platform (Brainomix 360) for suspected acute ischaemic stroke, combining e-ASPECTS automated scoring of early ischaemic change on non-contrast CT, e-CTA large-vessel-occlusion detection and collateral scoring on CT angiography, and e-CTP core/penumbra estimation on CT perfusion — surfaced to stroke physicians and neuroradiologists as decision support across the hyperacute pathway.

Neurology

Viz LVO

Viz.ai

Editorial summaryNeurology

SOMNUM

Honeynaps Co., Ltd.

Editorial summaryNeurology

COMPLETE CONTROL System Gen2

Coapt, LLC

Sourced from FDA AI listNeurology

BrainSee

Darmiyan, Inc.

Sourced from FDA AI listNeurology

BrainScope Ahead 100

BRAINSCOPE COMPANY, INC

Sourced from FDA AI listNeurology

EnsoSleep

EnsoData, Inc.

Sourced from FDA AI listNeurology

Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial

Brainlab AG

Sourced from FDA AI listNeurology

Embrace

Empatica Srl

Sourced from FDA AI listNeurology

Dreem 3S

Beacon Biosignals, Inc.

Sourced from FDA AI listNeurology

EYE-SYNC

SyncThink, Inc.

Sourced from FDA AI listNeurology

Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine

Brainlab AG

Sourced from FDA AI listNeurology

DeepRESP

Nox Medical Ehf

Sourced from FDA AI listNeurology

EpiMonitor

Empatica Srl

Sourced from FDA AI listNeurology

Mazor X System / Mazor X Stealth Edition

Mazor Robotics Ltd.

Sourced from FDA AI listNeurology

Persyst 14 EEG Review and Analysis Software

Persyst Development Corporation

Sourced from FDA AI listNeurology

Felix NeuroAI System

Fasikl Incorporated

Sourced from FDA AI listNeurology

Nelli (Version 7.11)

Neuro Event Labs OY

Sourced from FDA AI listNeurology

TMINI Miniature Robotic System

THINK Surgical, Inc.

Sourced from FDA AI listNeurology

autoSCORE (V 2.0.0)

Holberg EEG AS

Sourced from FDA AI listNeurology

NeuroMatch

LVIS Corporation

Sourced from FDA AI listNeurology

ARVIS® Shoulder

Insight Medical Systems, Inc.

Sourced from FDA AI listNeurology

OTS Hip

Ortoma AB

Sourced from FDA AI listNeurology

REMI-AI Rapid Detection Module (REMI-AI RDM)

Epitel, Inc

Sourced from FDA AI listNeurology

Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial

Brainlab AG

Sourced from FDA AI listNeurology

Ceribell Status Epilepticus Monitor

Ceribell, Inc.

Sourced from FDA AI listNeurology

Sense System with IBT Electrodes

Infinite Biomedical Technologies, LLC

Sourced from FDA AI listNeurology

7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application

7D Surgical Inc.

Sourced from FDA AI listNeurology

SomnoMetry

Neumetry Medical Inc

Sourced from FDA AI listNeurology

Cognoa ASD Diagnosis Aid

Cognoa, Inc.

Sourced from FDA AI listNeurology

Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application

Medtronic Navigation, Inc.

Sourced from FDA AI listNeurology

Brainscope Ahead 200

BRAINSCOPE COMPANY, INC.

Sourced from FDA AI listNeurology

EyeBOX

Oculogica, Inc.

Sourced from FDA AI listNeurology

Ahead 300

BRAINSCOPE COMPANY INC

Sourced from FDA AI listNeurology

NuVasive Pulse System

NuVasive, Incorporated

Sourced from FDA AI listNeurology

BrainScope TBI

BrainScope Company, Inc.

Sourced from FDA AI listNeurology

NeuroRPM

New Touch Digital Inc.

Sourced from FDA AI listNeurology

encevis (2.1)

AIT Austrian Institute of Technology GmbH

Sourced from FDA AI listNeurology

xvision Spine system

Augmedics, Ltd.

Sourced from FDA AI listNeurology

Canvas Dx

Cognoa, Inc.

Sourced from FDA AI listNeurology

xvision Spine system

Augmedics Ltd.

Sourced from FDA AI list

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