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Reviewed 6 Jul 2026

Completeness Comprehensive (86%)

Pixyl.Neuro.MS

FDA

Pixyl.Neuro.MS integrates into the routine workflow, to extract pertinent information on the size and location of Multiple Sclerosis (MS)-specific lesions, aimed at supporting the diagnosis and monitoring of patients. In case of multiple visits, the longitudinal analysis also provides data on the evolution of the lesions, and therefore on the activity of the disease with respect to diagnostic criteria. The software outputs both a quantitative report on lesion location, volume and evolution, as well as annotated MRI images with lesions labeled according to their evolution.

Supported by 3 papers

Key Features

Disease activity
Image annotation
Lesional volume quantification
Lesion classification
Lesion quantification
Longitudinal analysis
McDonald MRI criteria

General Information

Product name

Pixyl.Neuro.MS

Company

Pixyl

Modality

Main task

Not specified

Subspeciality

Neuro

Disease targeted

Multiple Sclerosis (MS)

Regulatory Information

CE Certification

Pathway:

MDR

Class:

Class IIa

Verified by Health AI Register

FDA Certification

Pathway:

510(k) cleared

Class:

Class II

Verified by Health AI Register

Other certifications

Not specified

Evidence & Research

Peer-Reviewed Papers

Deep Learning–Accelerated 3D FLAIR Enables Reliable MS Lesion Detection

American Journal of Neuroradiology · May 2026

Artificial intelligence in the detection of multiple sclerosis plaques: Can it influence the treatment decision?

Journal of Neuroradiology · Dec 2025

Artificial intelligence to predict clinical disability in patients with multiple sclerosis using FLAIR MRI

Diagnostic and Interventional Imaging · Jul 2020

Technical Papers

Leveraging 3d information in unsupervised brain mri segmentation

Use of PIXYL software analysis of brain MRI (with & without contrast) as valuable metric in clinical trial tracking in study of multiple sclerosis (MS) and related neurodegenerative processes

Use of Software Analytics of Brain MRI (with & without contrast) As Objective Metric in Neurological Disorders and Degenerative Diseases

Technical Specifications

Patient population age

Not specified

Input

MR sequence, 3D T2-weighted FLAIR, 2D T2-weighted FLAIR, 3D T1-weighted (optional), 3D T1-weighted + contrast (optional)

Input format

DICOM

Output

structured report, color-coded segmentation overlay, table of quantified values

Output format

Annotated dicom sequences, DICOM report, PDF report

Integration

Integration in standard reading environment (PACS), Integration via AI marketplace or distribution platform, Stand-alone webbased

Deployment

Cloud-based, Hybrid solution, Locally on dedicated hardware, Locally virtualized (virtual machine, Docker)

Trigger for analysis

Automatically, right after the image acquisition, On demand, triggered by a user through e.g. a button click, image upload

Processing time

1 - 10 minutes

Population

patients with known or suspected Multiple-Sclerosis

Market Presence

On market since

10-2019

AI Platforms

Blackford Analysis, GE Healthcare, Incepto, Philips Healthcare, Sectra, Siemens Healthineers

Resellers

Brainomix

Countries present

Paying clinical customers

>50

Research/test users

>50

Pricing Information

Pricing model

Subscription

Based on

Number of analyses, Number of installations

Source: Vendor | First published: Apr 11, 2024 | Last updated: Jul 6, 2026