Pixyl.Neuro.BV

Pixyl

Pixyl.Neuro.BV is a volumetry tool measuring brain atrophy. It integrates into the routine workflow to quantify the volume of different tissues and structures in the brain, as well as any changes from the previous visit if there is one (longitudinal analysis). It also compares patient values to a normative population. The software outputs a quantitative report on tissue and structure volume, and changes relative to the prior visit. It also provides graphs to visualize the evolution of certain volumes with respect to normative values.

Information source: Vendor
Last updated: Nov. 23, 2023

General Information

General
Product name	Pixyl.Neuro.BV
Company	Pixyl
Subspeciality	Neuro
Modality	MR
Disease targeted	Neurodegenerative diseases, dementia, Alzheimer’s disease, Multiple Sclerosis, Parkinson’s disease
Key-features	Brain volume quantification, brain segmentation, comparison with normative values, longitudinal analysis
Suggested use	During: perception aid (prompting all abnormalities/results/heatmaps)

Technical Specifications

Data characteristics
Population	patients with known or suspected neurodegenerative disease
Input	MR sequence, 3D T1-weighted image
Input format	DICOM
Output	structured quantitative report, table of quantified values, comparison with normative values, graphs of volume evolution with respect to normative values, brain MRI representative screenshots, longitudinal analysis
Output format	PDF report, DICOM report
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)
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model	Subscription
Based on	Number of installations, Number of analyses

Evidence

Evidence
Peer reviewed papers on performance
Non-peer reviewed papers on performance
Other relevant papers