Healthcare AI

Best AI Neurology Tools

Neurology AI covers three jobs. Stroke AI reads brain scans in minutes and alerts the stroke team, because every minute of delay costs brain tissue. EEG AI watches brain-wave recordings for seizures, which are often invisible at the bedside. Neuroimaging quantification measures brain volumes and lesions on MRI, which now matters for safety checks on new Alzheimer's drugs.

We ranked ten FDA-cleared clinical tools on evidence, regulatory status, workflow fit, scope and access. We cover brain-computer interfaces (BCIs) such as Neuralink and Synchron in a separate, unscored section, because they are experimental implants in early trials, not products a hospital can buy for routine care.

Quick answer

For stroke, RapidAI has the strongest evidence (its perfusion software selected patients in the DEFUSE 3 randomised trial) and Viz.ai has the best care-coordination app, with 50+ FDA clearances and 1,800 hospitals. Brainomix has the largest real-world outcome study, linked to doubled thrombectomy rates across NHS England. For seizures in the ICU or emergency department, Ceribell is the clear pick. For Alzheimer's and MS MRI, choose NeuroQuant or icobrain. No brain-computer interface is FDA-approved for long-term use yet.

Top picks at a glance

Scoreboard

Scores are out of 10. The overall score is the weighted average of the criteria below.

#ToolOverallClinical evidence & safetyRegulatory statusWorkflow integrationClinical scopeAccess & reimbursementPrice fromBest for
1RapidAI
RapidAI
8.79.59.08.59.05.0Custom quoteStroke centres that rely on perfusion imaging to select patients for thrombectomy
2Viz.ai
Viz.ai
8.68.59.59.59.04.0Custom quoteHospital networks that want AI alerts plus stroke-team coordination on phones
3Ceribell
Ceribell
8.18.09.08.57.56.5Custom quoteICUs and emergency departments that need rapid seizure detection without a full EEG team
4Brainomix 360
Brainomix
7.69.07.08.07.54.0Custom quoteNational or regional stroke networks, especially outside the US
5Persyst
Persyst Development
7.68.08.58.07.05.0Custom quoteEEG labs and epilepsy units reviewing long recordings
6Cortechs.ai NeuroQuant
Cortechs.ai
7.57.58.58.07.54.0Custom quoteMemory clinics and radiology groups measuring brain volume, ARIA and amyloid
7icometrix icobrain
icometrix
7.47.58.57.57.54.0Custom quoteMS and Alzheimer's treatment monitoring on MRI
8Combinostics cNeuro
Combinostics
6.87.07.57.07.04.0Custom quoteMemory clinics that want MRI and PET measures in one dementia report
9Methinks AI
Methinks
6.56.57.07.56.04.0Custom quoteSmaller hospitals that see strokes on non-contrast CT only
10encevis
AIT Austrian Institute of Technology
6.57.07.07.06.04.0Custom quoteEuropean EEG labs wanting an alternative to Persyst

Expert reviews

#1 · Stroke centres that rely on perfusion imaging to select patients for thrombectomy

RapidAI

by RapidAI · Enterprise · Custom quote
8.7/10

RapidAI earns the top spot on evidence. Its perfusion software, which maps how much brain tissue is dead and how much can still be saved, was used to select patients in DEFUSE 3, the randomised trial that extended the thrombectomy window to 16 hours. That work fed directly into stroke guidelines, and RapidAI says its perfusion analysis is the only one validated in randomised trials.

The platform now covers much more than perfusion: large and medium vessel occlusion detection, non-contrast CT, haemorrhage, midline shift and aortic imaging. In November 2025 it added five FDA clearances at once, and Lumina 3D creates instant 3D views of head and neck CT angiograms. RapidAI has 20 entries on the FDA AI list and says it runs in more than 2,500 hospitals in over 100 countries.

Its care-coordination app is solid but less central to its identity than Viz.ai's.

Pick it if your stroke programme depends on advanced imaging to decide who gets thrombectomy. Skip it if your main pain point is team communication rather than image analysis.

Score breakdown

Clinical evidence & safety9.5
Regulatory status9.0
Workflow integration8.5
Clinical scope9.0
Access & reimbursement5.0

Key facts

Pricing
Custom quote (Hospital licences; no public pricing.)
Free option
No
Platforms
PACS, iOS, Android, Web
FDA list
20 entries on the FDA AI device list (June 2026)
New clearances
5 modules cleared November 2025: DeltaFuse, LMVO, MLS, OH and Aortic
Reach (vendor)
2,500+ hospitals in 100+ countries; 700+ clinical studies
Trial evidence
RAPID perfusion used to select patients in the DEFUSE 3 randomised trial (NEJM, 2018)

What we like

  • Perfusion software validated in randomised trials
  • Broad FDA-cleared neurovascular suite
  • Large global footprint
  • Fast 3D CTA reconstruction

Watch out for

  • Quote-only pricing
  • Care-coordination features less developed than Viz.ai's
  • Many headline figures are vendor-reported
#2 · Hospital networks that want AI alerts plus stroke-team coordination on phones

Viz.ai

by Viz.ai · Enterprise · Custom quote
8.6/10

Viz.ai invented the category. In February 2018 the FDA granted it the first De Novo authorisation for AI software that alerts a specialist to a suspected large vessel occlusion stroke. Its real strength is what happens next: the Viz app puts the scan, the alert and a secure team chat on every stroke team member's phone, so a neurointerventionalist at home can see images and accept a transfer within minutes.

The platform has grown to 50+ 510(k) clearances across stroke, brain bleeds, aneurysms and subdural haematoma, plus cardiology, pulmonary embolism and aortic disease. Viz.ai says it is deployed at 1,800 hospitals.

The evidence base is large but mostly observational: many single- and multi-centre studies report faster treatment times after adoption, but there is no randomised trial of the software itself. That is why RapidAI edges it on evidence.

Pick it if you run a hub-and-spoke stroke network where communication delays cost the most time. Skip it if you mainly need advanced perfusion analysis.

Score breakdown

Clinical evidence & safety8.5
Regulatory status9.5
Workflow integration9.5
Clinical scope9.0
Access & reimbursement4.0

Key facts

Pricing
Custom quote (Enterprise licences; no public pricing.)
Free option
No
Platforms
iOS, Android, Web, PACS, EHR
First clearance
FDA De Novo for Viz ContaCT, February 2018: the first AI triage software cleared in the US
Clearances (vendor)
1 De Novo plus 50+ 510(k) clearances
Reach (vendor)
1,800 hospitals and health systems in the US and Europe
Recent
Viz Subdural Plus cleared June 2025 for measuring subdural bleeds

What we like

  • First FDA-authorised AI triage product
  • Best team communication and transfer workflow
  • 50+ FDA clearances across neuro and vascular
  • Large US and European footprint

Watch out for

  • No randomised trial of the software
  • Quote-only pricing
  • Most value depends on network-wide rollout
#3 · ICUs and emergency departments that need rapid seizure detection without a full EEG team

Ceribell

by Ceribell · Enterprise · Custom quote
8.1/10

Ceribell solves a practical problem: conventional EEG needs a technician to glue on electrodes and a specialist to read it, which many hospitals cannot provide at 2am. Ceribell uses a headband that a nurse can put on in minutes, and its Clarity AI watches the signal continuously and flags seizures.

Its regulatory record is the strongest in EEG AI. Clarity is cleared for patients of all ages, including pre-term newborns since November 2025. ClarityPro is cleared to diagnose electrographic status epilepticus (a prolonged seizure that is a medical emergency) in adults, and CMS pays hospitals an add-on of up to $913.90 per eligible Medicare case. A delirium monitoring tool was cleared in December 2025, and a stroke detection tool has Breakthrough Device designation.

The limits are scope and cost structure. It uses fewer electrodes than a full EEG, so it complements rather than replaces formal EEG, and hospitals commit to hardware and disposables.

Pick it if your ICU or emergency department has limited EEG access. Skip it if you already run 24/7 full EEG monitoring with in-house readers.

Score breakdown

Clinical evidence & safety8.0
Regulatory status9.0
Workflow integration8.5
Clinical scope7.5
Access & reimbursement6.5

Key facts

Pricing
Custom quote (Hospitals buy the headband and recorder hardware plus disposables and software; CMS pays a new-technology add-on of up to $913.90 per eligible Medicare case for ClarityPro.)
Free option
No
Platforms
Point-of-care device, Web portal
Seizure AI
Clarity algorithm FDA-cleared for all ages, from pre-term neonates (November 2025) to adults
Status epilepticus
ClarityPro cleared to diagnose electrographic status epilepticus in adults
Delirium
Delirium screening and monitoring cleared December 2025
Pipeline
FDA Breakthrough Device designation for LVO stroke detection (January 2026)

What we like

  • Seizure AI cleared for every age group
  • Nurse-applied headband works in minutes
  • CMS new-technology add-on payment for ClarityPro
  • Expanding into delirium and stroke

Watch out for

  • Reduced electrode count versus full EEG
  • Hardware and disposables add ongoing cost
  • Quote-only pricing
#4 · National or regional stroke networks, especially outside the US

Brainomix 360

by Brainomix · Enterprise · Custom quote
7.6/10

Brainomix has the most convincing real-world outcome data in stroke AI. A study published in The Lancet Digital Health in December 2025 tracked more than 450,000 admissions across 107 NHS England hospitals, including over 71,000 ischaemic stroke patients before and after AI roll-out. Thrombectomy rates doubled at the 26 hospitals using Brainomix 360, against a 63% rise elsewhere, and transfer times at primary stroke centres fell by 64 minutes. It is observational, and Brainomix staff co-authored it alongside the NHS national clinical director for stroke, but the scale is unmatched.

In the US its footprint is smaller. The FDA has cleared its e-ASPECTS scoring and, in 2025, a feature that estimates the stroke core from ordinary non-contrast CT, which helps hospitals without perfusion imaging.

Pick it if you run a regional stroke network, particularly in the UK or Europe, and want proven impact on treatment rates. Skip it if you need the broadest US-cleared menu; RapidAI and Viz.ai have more.

Score breakdown

Clinical evidence & safety9.0
Regulatory status7.0
Workflow integration8.0
Clinical scope7.5
Access & reimbursement4.0

Key facts

Pricing
Custom quote (Network and hospital licences; deployed across NHS England stroke networks.)
Free option
No
Platforms
PACS, Web, iOS, Android
Outcome study
Lancet Digital Health (Dec 2025): 71,000+ stroke patients, 107 NHS England hospitals
Result
Thrombectomy rates rose 100% at AI sites vs 63% at non-AI sites; transfer times 64 minutes shorter
FDA
e-ASPECTS cleared; non-contrast CT core volume feature cleared in 2025
Origin
Oxford University spin-out

What we like

  • Largest real-world stroke AI outcome study
  • Works from standard non-contrast CT
  • Proven at national scale in the NHS
  • Shorter inter-hospital transfer times

Watch out for

  • Smaller US-cleared portfolio
  • Key study was observational and vendor co-authored
  • Quote-only pricing
#5 · EEG labs and epilepsy units reviewing long recordings

Persyst

by Persyst Development · Paid · Custom quote
7.6/10

Persyst is the long-standing standard for EEG review software. Its algorithms mark likely seizures and spikes in long recordings and turn hours of brain waves into trend charts a neurologist can scan in minutes. Most large EEG vendors support it, and it is often the software neurophysiologists trained on.

The regulatory position is strong. Persyst 15 includes FDA-cleared seizure detection for adults and an electrographic status epilepticus component that can support a diagnosis in adults, and the FDA cleared a newer version (K252160) in October 2025. In December 2025 Natus won clearance for its BrainWatch point-of-care EEG with Persyst built in, which makes Persyst a direct rival to Ceribell at the bedside.

It is software for experts. It needs a full EEG setup and trained readers, and its seizure detection clearance covers adults rather than all ages.

Pick it if you run an EEG lab or epilepsy monitoring unit. Skip it if you need a nurse-applied system for units without EEG staff; look at Ceribell.

Score breakdown

Clinical evidence & safety8.0
Regulatory status8.5
Workflow integration8.0
Clinical scope7.0
Access & reimbursement5.0

Key facts

Pricing
Custom quote (Licensed per workstation or bundled with EEG systems such as Natus BrainWatch.)
Free option
No
Platforms
Windows, EEG systems
Latest FDA
K252160 (October 2025) for Persyst EEG review software
Status epilepticus
ESE component cleared to diagnose electrographic status epilepticus in adults
Partners
Integrated into Natus BrainWatch point-of-care EEG (cleared December 2025)
Features
Seizure detection, seizure probability, spike detection and trend displays

What we like

  • Widely used standard in EEG labs
  • FDA-cleared status epilepticus diagnosis for adults
  • Works with major EEG systems
  • Now available at the bedside via Natus BrainWatch

Watch out for

  • Needs full EEG setup and expert readers
  • Seizure detection clearance limited to adults
  • Pricing not published
#6 · Memory clinics and radiology groups measuring brain volume, ARIA and amyloid

Cortechs.ai NeuroQuant

by Cortechs.ai · Enterprise · Custom quote
7.5/10

NeuroQuant is one of the longest-used brain MRI measurement tools. It segments the brain into regions and compares volumes, such as the hippocampus, with age-matched norms, which helps with dementia, epilepsy and brain injury work-ups.

Its relevance has grown with anti-amyloid Alzheimer's drugs, which require repeated MRI checks for ARIA, a side effect that shows up as brain swelling (ARIA-E) or small bleeds (ARIA-H). NeuroQuant 5.0, cleared in September 2024, helps radiologists segment and quantify these changes. In August 2026 the FDA cleared NeuroQuant PET (K261916), which reports amyloid PET results as standardised uptake ratios and Centiloids for three common tracers. That lets one vendor cover both the MRI and PET parts of an Alzheimer's treatment pathway.

Most of its accuracy data comes from validation studies rather than outcome trials, which is typical for measurement tools.

Pick it if you run a memory clinic or radiology service supporting anti-amyloid treatment. Skip it if you mainly need MS lesion tracking; icobrain is stronger there.

Score breakdown

Clinical evidence & safety7.5
Regulatory status8.5
Workflow integration8.0
Clinical scope7.5
Access & reimbursement4.0

Key facts

Pricing
Custom quote (Per-scan or site licensing; not published.)
Free option
No
Platforms
PACS, Cloud
NeuroQuant 5.0
FDA-cleared September 2024 with ARIA-E and ARIA-H quantification
NeuroQuant PET
K261916, cleared 18 August 2026: amyloid PET SUVR and Centiloid reports
Use
Brain volume measurement on MRI for dementia, epilepsy and brain injury

What we like

  • Long track record in brain volumetry
  • ARIA quantification on MRI
  • New FDA-cleared amyloid PET module
  • Covers dementia, epilepsy and brain injury

Watch out for

  • Evidence mainly technical validation
  • Quote-only pricing
  • Less focused on MS than icobrain
#7 · MS and Alzheimer's treatment monitoring on MRI

icometrix icobrain

by icometrix · Enterprise · Custom quote
7.4/10

icometrix, a Belgian company, makes icobrain, a family of MRI tools for multiple sclerosis, dementia and brain injury. Its standout product is icobrain aria, which the FDA cleared in November 2024 as the first AI software to detect, measure and grade ARIA, the brain swelling and micro-bleeds that anti-amyloid Alzheimer's drugs can cause. The company reports that radiologists using it were 16% more sensitive for ARIA-E and 10% more sensitive for ARIA-H; that comes from a company-backed reader study.

Its MS module tracks new and enlarging lesions and brain volume loss over time, which helps neurologists judge whether a treatment is working.

icobrain and NeuroQuant overlap heavily, and the choice often comes down to which PACS integration and reports your radiologists prefer. We place icobrain just behind because NeuroQuant now also covers amyloid PET.

Pick it if you manage many MS patients or run an anti-amyloid infusion programme. Skip it if you need PET quantification from the same vendor.

Score breakdown

Clinical evidence & safety7.5
Regulatory status8.5
Workflow integration7.5
Clinical scope7.5
Access & reimbursement4.0

Key facts

Pricing
Custom quote (Site and per-scan licensing; not published.)
Free option
No
Platforms
PACS, Cloud
icobrain aria
FDA-cleared 7 November 2024: first AI to detect, measure and grade ARIA
Reader study (vendor)
16% higher sensitivity for ARIA-E and 10% for ARIA-H with AI assistance
Europe
icobrain aria approved in Europe in April 2025
Other modules
MS lesion tracking, dementia volumetry and traumatic brain injury

What we like

  • First FDA-cleared AI for ARIA grading
  • Strong MS lesion tracking
  • Cleared in the US and Europe
  • Longitudinal reports for treatment monitoring

Watch out for

  • ARIA accuracy gains come from a company-backed study
  • No PET module
  • Quote-only pricing
#8 · Memory clinics that want MRI and PET measures in one dementia report

Combinostics cNeuro

by Combinostics · Enterprise · Custom quote
6.8/10

Combinostics, a Finnish company, builds cNeuro, a dementia-focused platform. cNeuro cMRI measures atrophy in brain regions and white matter changes, and cNeuro cPET, cleared by the FDA in September 2023, quantifies PET scans. In Europe it also offers cDSI, a disease state index that compares a patient's data with large reference cohorts to suggest which type of dementia is most likely. That decision-support part is CE-marked but not FDA-cleared, so US users get the measurement tools only.

Its approach grew out of European dementia research projects, and it is well suited to memory clinics that combine MRI, PET and cognitive tests. In the US it is a smaller player than NeuroQuant or icobrain, and we found no recent outcome studies.

Pick it if you run a European memory clinic and want decision support across several tests. Skip it if you are in the US and need ARIA monitoring; its competitors have specific clearances for that.

Score breakdown

Clinical evidence & safety7.0
Regulatory status7.5
Workflow integration7.0
Clinical scope7.0
Access & reimbursement4.0

Key facts

Pricing
Custom quote (Licensing not published.)
Free option
No
Platforms
Cloud, PACS
cNeuro cMRI
FDA 510(k) cleared January 2018 for brain atrophy and white matter measures
cNeuro cPET
FDA 510(k) cleared September 2023
cDSI
Dementia decision-support index is CE-marked but not FDA-cleared

What we like

  • MRI and PET quantification cleared in the US
  • Multi-test dementia decision support in Europe
  • Research-grade reference cohorts

Watch out for

  • cDSI decision support not FDA-cleared
  • No specific ARIA clearance found
  • Small US footprint
#9 · Smaller hospitals that see strokes on non-contrast CT only

Methinks AI

by Methinks · Enterprise · Custom quote
6.5/10

Methinks, a Barcelona-based start-up, focuses on a real gap: many small and rural hospitals only do a plain (non-contrast) CT scan when a stroke patient arrives, and most LVO algorithms need a CT angiogram. In July 2025 the FDA cleared Methinks NCCT Stroke to flag suspected large vessel occlusions from non-contrast CT alone, and a second 2025 clearance covers CTA, including more distal M2 occlusions.

The company says its non-contrast tool cuts false negatives by nearly half compared with the best competing product, and reports 98.2% sensitivity and 91.6% specificity for its CTA tool. These are figures from its regulatory validation, and we found little independent published data yet.

It is a narrower and younger product than RapidAI or Viz.ai, without their care-coordination depth.

Pick it if you run a spoke hospital without routine CTA and want earlier transfer decisions. Skip it if you need a full stroke platform.

Score breakdown

Clinical evidence & safety6.5
Regulatory status7.0
Workflow integration7.5
Clinical scope6.0
Access & reimbursement4.0

Key facts

Pricing
Custom quote (Pricing not published.)
Free option
No
Platforms
PACS, Cloud, Mobile
FDA (NCCT)
510(k) July 2025: suspected LVO triage from non-contrast CT
FDA (CTA)
Second 510(k) in 2025 for CTA stroke, including distal M2 occlusions
CTA performance (vendor)
98.2% sensitivity and 91.6% specificity

What we like

  • Detects LVO on non-contrast CT
  • Covers distal M2 occlusions on CTA
  • Useful for rural and spoke hospitals

Watch out for

  • Mostly vendor-reported performance data
  • Narrow scope
  • Small installed base
#10 · European EEG labs wanting an alternative to Persyst

encevis

by AIT Austrian Institute of Technology · Paid · Custom quote
6.5/10

encevis is EEG analysis software from the Austrian Institute of Technology. Like Persyst, it scans long EEG recordings for seizures and for rhythmic and periodic patterns common in intensive care, and shows trends that speed up review. It is CE-marked and has been used mostly in European epilepsy and ICU settings.

The FDA cleared it in September 2024 (K240993), so it is now an option for US labs. Independent comparisons of commercial seizure detectors, including encevis and Persyst, have been published, and a 2025 paper compared versions of these tools, which is healthy for a field that relies mostly on vendor validation.

Its US presence and integration list are smaller than Persyst's, and it has no point-of-care hardware partner comparable to Natus or Ceribell.

Pick it if you run a European EEG lab or want a second-opinion detector. Skip it if you need the most widely supported tool in US EEG systems.

Score breakdown

Clinical evidence & safety7.0
Regulatory status7.0
Workflow integration7.0
Clinical scope6.0
Access & reimbursement4.0

Key facts

Pricing
Custom quote (Licensed per workstation; pricing not published.)
Free option
No
Platforms
Windows, EEG systems
FDA
510(k) K240993, cleared 27 September 2024
Features
Seizure detection, rhythmic and periodic pattern detection, and trend displays for long EEG
Developer
Austrian Institute of Technology, a public research organisation

What we like

  • FDA-cleared since 2024 and CE-marked
  • Detects ICU rhythmic and periodic patterns
  • Developed by a public research institute

Watch out for

  • Small US footprint
  • Fewer EEG system integrations than Persyst
  • No bedside hardware partner

How we scored these tools

Each tool is scored 0–10 on the criteria below, using public evidence: independent benchmarks, vendor documentation and pricing pages, aggregate user ratings and reputable reviews. The overall score is the weighted average. Nobody pays to be listed. Read our full methodology.

CriterionWeightWhat we look at
Clinical evidence & safety30%Randomised trials, large real-world outcome studies and independent validation. Vendor sensitivity figures count less.
Regulatory status20%FDA 510(k)/De Novo clearances (with numbers where available), CE/UKCA marks and the breadth of cleared indications.
Workflow integration20%PACS, EEG and EHR integration, mobile alerts, speed and how well the tool fits a stroke or ICU team's routine.
Clinical scope20%How many conditions and scan types the tool covers, from ischaemic stroke to haemorrhage, seizures, dementia and MS.
Access & reimbursement10%Public pricing, reimbursement such as CMS new-technology payments, and availability outside large hospitals.

Brain-computer interfaces: where the trials stand

Brain-computer interfaces (BCIs) record brain signals and turn them into commands, such as moving a cursor or producing speech. They are not scored above because none is approved for long-term clinical use. Status as of September 2026:

Company Device Approach Regulatory and trial status
Neuralink N1 implant Threads inserted into the cortex by a robot Early feasibility trials (PRIME, CONVOY, VOICE) in the US, Canada, UK and UAE. Neuralink reported 12 participants in September 2025; press reports cite higher counts in 2026. Breakthrough designations for speech and Blindsight (vision).
Synchron Stentrode Placed through a blood vessel, no open brain surgery COMMAND early feasibility study (6 patients) met its 12-month safety endpoint. Raised $200M in November 2025 to run a pivotal trial, planned for 2026, towards the first BCI premarket approval (PMA).
Precision Neuroscience Layer 7 Cortical Interface Thin film with 1,024 electrodes on the brain surface FDA 510(k) K242618 (March 2025) for implants of up to 30 days. This is a temporary recording device, not a permanent BCI.
Paradromics Connexus Fully implanted high-channel device FDA IDE (November 2025) for the Connect-One speech study; first patient implanted 17 June 2026 at University of Michigan Health.

What this means: the first permanent BCI approval is still years away. Precision's 510(k) is real but covers short-term use only. Treat vendor claims about "FDA approval" carefully: an IDE lets a company run a trial, and a Breakthrough designation speeds review, but neither is an approval.

Key evidence at a glance

Evidence Tool What it showed
DEFUSE 3 randomised trial (NEJM, 2018) RapidAI (RAPID perfusion) Perfusion-selected patients benefited from thrombectomy 6-16 hours after onset
Lancet Digital Health, Dec 2025 (107 NHS hospitals) Brainomix 360 Thrombectomy rates doubled at AI sites vs 63% rise elsewhere; transfers 64 min faster
FDA De Novo, 2018 Viz.ai ContaCT First AI triage software authorised in the US
CMS NTAP decision Ceribell ClarityPro Up to $913.90 add-on payment per eligible Medicare case
Company-backed reader study icobrain aria ARIA-E sensitivity up 16%, ARIA-H up 10%

Most other figures, such as sensitivity and specificity, come from vendor regulatory studies. They show the tool works on test data, not that patients do better.

How to choose

  • Stroke network with perfusion imaging: RapidAI.
  • Stroke network where transfer and communication are the bottleneck: Viz.ai.
  • Spoke hospital with CT only: Brainomix (core volume from non-contrast CT) or Methinks.
  • ICU or emergency seizures without 24/7 EEG staff: Ceribell, or Natus BrainWatch with Persyst.
  • EEG lab: Persyst, with encevis as an alternative.
  • Alzheimer's infusion or MS clinic: NeuroQuant or icobrain; Combinostics in European memory clinics.

Before buying, confirm the exact FDA indication (for example, adults only versus all ages) and check whether your hospital can bill for it. Only a few neurology AI tools, such as Ceribell ClarityPro, have specific Medicare add-on payments.

Compliance and data protection

All clinical vendors here sell to hospitals and sign business associate agreements (BAAs) under HIPAA in the US and data processing agreements under GDPR in Europe. Stroke apps push images to clinicians' phones, so check that the app encrypts data, supports your mobile device management and logs every access. For cloud-based MRI quantification, ask where scans are processed and whether de-identified images are used to train future models.

Disclaimer and methodology

This page compares software and devices for healthcare organisations and professionals. It is not medical advice. If you think someone is having a stroke, call emergency services immediately. Clinical evidence carries 30% of our score and regulatory status 20%. We used FDA records and peer-reviewed studies first, and vendor announcements for features and adoption, labelled as vendor claims. See how we rank.

Expert tips
  1. Map your stroke pathway first. If most delay happens during transfer, a coordination app (Viz.ai) will save more minutes than a better algorithm.
  2. For spoke hospitals without CTA or perfusion, shortlist tools cleared for non-contrast CT (Brainomix core volume, Methinks NCCT).
  3. Check the age range in each EEG AI clearance. Ceribell Clarity covers all ages; several other seizure detectors are cleared for adults only.
  4. If you start an anti-amyloid infusion programme, set up ARIA quantification before the first patient, so you have a consistent baseline scan.
  5. When a BCI company says "FDA approval", ask which kind: an IDE or Breakthrough designation is not a marketing approval.

Jargon explained

LVO
Large vessel occlusion: a clot blocking a major brain artery. These strokes often need thrombectomy.
Thrombectomy
A procedure that pulls a clot out of a brain artery through a catheter.
Perfusion imaging
A scan that shows blood flow, so doctors can see which brain tissue is dead and which can still be saved.
Status epilepticus
A seizure that lasts too long or repeats without recovery in between; a medical emergency.
ARIA
Amyloid-related imaging abnormalities: swelling or small bleeds on MRI caused by some Alzheimer's drugs.
IDE
Investigational device exemption: FDA permission to test an unapproved device in a clinical trial.

Frequently asked questions

What is the best AI for stroke detection?

RapidAI has the strongest trial evidence, Viz.ai has the best team-coordination app and the most FDA clearances, and Brainomix has the largest real-world outcome study. All three are FDA-cleared.

Is Neuralink FDA-approved?

No. Neuralink is running early feasibility trials under FDA investigational device exemptions and has Breakthrough Device designations. No permanent brain-computer interface is FDA-approved as of September 2026.

Which brain-computer interface is closest to approval?

Synchron planned a pivotal trial for 2026 after its six-patient COMMAND study met its safety endpoint. Precision Neuroscience holds a 510(k), but only for implants of up to 30 days.

Can AI detect seizures without a neurologist?

AI can flag likely seizures, and Ceribell and Persyst have FDA clearances for diagnosing status epilepticus in adults. A clinician still reviews the EEG and decides on treatment.

What is ARIA and why does AI help?

ARIA is brain swelling or small bleeds caused by anti-amyloid Alzheimer's drugs. Patients need repeated MRI checks, and tools such as icobrain aria and NeuroQuant help radiologists spot and measure changes consistently.

How much does neurology AI cost?

Vendors do not publish prices. Stroke and imaging tools are sold as hospital licences, and Ceribell also sells hardware and disposables. Check whether a Medicare add-on payment applies.

Sources

Every fact on this page comes from public information. Vendor figures are labelled as vendor claims.

  1. FDA permits marketing of clinical decision support software for alerting providers of a potential stroke (US FDA)
  2. Viz.ai receives FDA 510(k) clearance for subdural measurements (Viz.ai)
  3. RapidAI extends the reach of deep clinical AI with five new FDA clearances (RapidAI)
  4. Thrombectomy for stroke at 6 to 16 hours with selection by perfusion imaging (DEFUSE 3) (New England Journal of Medicine)
  5. Top 10 AI vendors by FDA approvals (The Imaging Wire)
  6. Brainomix study in Lancet Digital Health on thrombectomy rates (Brainomix via PR Newswire)
  7. Brainomix gains FDA clearance for core volume assessment feature (NeuroNews International)
  8. Methinks AI receives FDA 510(k) clearance for NCCT Stroke (NeuroNews International)
  9. Methinks AI secures second FDA clearance for contrast imaging (Methinks)
  10. Ceribell receives FDA 510(k) clearance for Clarity algorithm for neonates (Ceribell)
  11. Ceribell status epilepticus software receives FDA clearance with CMS NTAP (NeurologyLive)
  12. Ceribell receives Breakthrough Device designation for LVO stroke detection (Ceribell)
  13. Persyst 510(k) K252160 (US FDA)
  14. Natus announces FDA clearance for status epilepticus indication in BrainWatch (Natus via PR Newswire)
  15. Systematic comparison of commercial seizure detection software (PubMed)
  16. FDA authorizes the first AI-driven MRI solution for safer Alzheimer's treatment (icobrain aria) (icometrix via PR Newswire)
  17. Cortechs.ai receives FDA clearance for NeuroQuant 5.0 (Cortechs.ai via PR Newswire)
  18. Cortechs.ai announces FDA clearance for NeuroQuant PET (Cortechs.ai via PR Newswire)
  19. Combinostics receives FDA clearance for cNeuro cMRI (Combinostics)
  20. Combinostics cNeuro cPET receives FDA 510(k) clearance (Combinostics)
  21. Neuralink (Wikipedia)
  22. Synchron brain implant targets 2026 pivotal trial (Tech Times)
  23. Precision Neuroscience receives FDA clearance for high-resolution cortical electrode array (GlobeNewswire)
  24. Paradromics completes first Connexus BCI implantation (Paradromics)