Pixyl.Neuro.FL

Pixyl

Pixyl.Neuro.FL integrates into the routine workflow to automatically identify, highlight and quantify any hyperintense regions in the MRI, aimed at supporting the diagnosis and monitoring of patients. In a longitudinal study where there are multiple visits, the software identifies any evolution of hyperintensities compared to the previous visit and quantifies that change, thus providing data on the activity of the disease. The software outputs both a quantitative report on total lesion volume and evolution, as well as annotated MRI images with lesions contoured.

Information source: Vendor
Last updated: April 11, 2024

General Information

General
Product name	Pixyl.Neuro.FL
Company	Pixyl
Subspeciality	Neuro
Modality	MR
Disease targeted	Leukoencephalopathy, vascular dementia, small-vessel disease
Key-features	White matter hyperintensities detection, white matter hyperintensities volume quantification, longitudinal analysis
Suggested use	During: perception aid (prompting all abnormalities/results/heatmaps)

Technical Specifications

Data characteristics
Population	patients with known or suspected White-Matter Hyperintensities
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, segmentation overlay, quantified values
Output format	PDF report, DICOM report, annotated DICOM sequences
Technology
Integration	Integration in standard reading environment (PACS), Integration via AI marketplace or distribution platform, Stand-alone webbased
Deployment	Locally on dedicated hardware, Locally virtualized (virtual machine, docker), Cloud-based, Hybrid solution
Trigger for analysis	Automatically, right after the image acquisition, On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time	1 - 10 minutes

Regulatory

Certification
CE	Certified, Class IIa , MDR
FDA	510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE)	Pixyl.Neuro is intended for the automatic labelling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MRI images. Volumetric measurements may be compared to reference percentile data.

Market

Market presence
On market since	10-2019
Distribution channels	Incepto, GE, Siemens, Blackford
Countries present (clinical, non-research use)	>7
Paying clinical customers (institutes)	>50
Research/test users (institutes)	>50
Pricing
Pricing model	Subscription
Based on	Number of installations, Number of analyses

Evidence

Evidence
Peer reviewed papers on performance	Artificial intelligence to predict clinical disability in patients with multiple sclerosis using FLAIR MRI (read)
Non-peer reviewed papers on performance	Leveraging 3d information in unsupervised brain mri segmentation (read) 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 (read) Use of Software Analytics of Brain MRI (with & without contrast) As Objective Metric in Neurological Disorders and Degenerative Diseases (read)
Other relevant papers