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

qER

Qure.ai

CEFDAHC

Verified clinician reviews launching

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

icobrain

icometrix (a GE HealthCare company)

CEFDA

Verified clinician reviews launching

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

e-Stroke Suite

Brainomix

CEFDA

Verified clinician reviews launching

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

EarliPoint System

EarliTec Diagnostics, Inc.

Sourced from FDA AI listNeurology

Embrace

Empatica Srl

Sourced from FDA AI listNeurology

EnsoSleep

EnsoData, Inc.

Sourced from FDA AI listNeurology

Dreem 3S

Beacon Biosignals, Inc.

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

Felix NeuroAI System

Fasikl Incorporated

Sourced from FDA AI listNeurology

Ceribell Delirium Monitor System

Ceribell, Inc.

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

REMI AI Discrete Detection Module

Epitel, Inc.

Sourced from FDA AI listNeurology

NeuroMatch

LVIS Corporation

Sourced from FDA AI listNeurology

ARVIS® Shoulder

Insight Medical Systems, Inc.

Sourced from FDA AI listNeurology

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

Epitel, Inc

Sourced from FDA AI listNeurology

OTS Hip

Ortoma AB

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

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

EYE-SYNC

SyncThink, Inc.

Sourced from FDA AI listNeurology

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

Medtronic Navigation, Inc.

Sourced from FDA AI listNeurology

Cognoa ASD Diagnosis Aid

Cognoa, Inc.

Sourced from FDA AI listNeurology

EyeBOX

Oculogica, Inc.

Sourced from FDA AI listNeurology

Ahead 300

BRAINSCOPE COMPANY INC

Sourced from FDA AI listNeurology

Onera SleepMap (SLEEPMAP)

Onera B.V.

Sourced from FDA AI listNeurology

NuVasive Pulse System

NuVasive, Incorporated

Sourced from FDA AI listNeurology

Brainscope Ahead 200

BRAINSCOPE COMPANY, INC.

Sourced from FDA AI listNeurology

EarliPoint Assessment

Earlitec Diagnostics

Sourced from FDA AI listNeurology

BrainScope TBI

BrainScope Company, Inc.

Sourced from FDA AI listNeurology

BrainScope Ahead 100

BRAINSCOPE COMPANY, INC

Sourced from FDA AI listNeurology

encevis (2.1)

AIT Austrian Institute of Technology GmbH

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

xvision Spine system

Augmedics, Ltd.

Sourced from FDA AI listNeurology

Canvas Dx

Cognoa, Inc.

Sourced from FDA AI listNeurology

EarliPoint System

EarliTec Diagnostics

Sourced from FDA AI listNeurology

xvision Spine system

Augmedics Ltd.

Sourced from FDA AI listNeurology

Falcon HST

Compumedics Limited

Sourced from FDA AI listNeurology

ClearPoint System (Software Version 3.0)

ClearPoint Neuro, Inc.

Sourced from FDA AI listNeurology

ARVIS® Shoulder

Kico Knee Innovation Company Pty Ltd

Sourced from FDA AI listNeurology

FLASH EVD System (10-0002)

7D Surgical ULC

Sourced from FDA AI listNeurology

BrainSee

Darmiyan, Inc.

Sourced from FDA AI list