JSON twin: https://www.healthaidb.com/software/pixyl-neuro-fl.json
Pixyl
https://pixyl.ai/neuroscience/
Automated MRI analysis software that detects, segments and quantifies white-matter hyperintensities (WMH) with longitudinal comparison and report generation.
Pixyl.Neuro.FL is a CE- and FDA-cleared MR imaging software that automatically identifies, contours and volumetrically quantifies hyperintense brain lesions (FLAIR) and reports lesion volumes and longitudinal change; outputs include annotated DICOM sequences, structured/DICOM/PDF reports and segmentation overlays. Deployable cloud, hybrid or local and integratable into PACS and AI marketplaces; typical processing time 1–10 minutes.
yes
2015
P2030
2025-09-07
commercial proprietary
Subscription pricing (based on number of analyses and number of installations); contact vendor for quotes and trial information.
subscription
—
2019
Docker/VM or dedicated Linux server for on‑prem; internet connection for cloud deployments
product
1.0
{
"company_name": "Pixyl",
"company_url": "https://pixyl.ai/",
"company_offices": [
"France"
],
"company_founding": "2015",
"product_url": "https://pixyl.ai/neuroscience/",
"categories": [
"clinical",
"diagnostic",
"radiology",
"neuroimaging",
"imaging-analysis",
"artificial-intelligence"
],
"market_segment": [
"enterprise",
"healthcare providers",
"research"
],
"links": [
"https://pixyl.ai/",
"https://pixyl.ai/neuroscience/",
"https://accessdata.fda.gov/cdrh_docs/pdf21/K213253.pdf",
"https://healthairegister.com/products/pixyl-neuro-fl/",
"https://pixyl.ai/pixyl-receives-fda-clearance-for-ai-powered-brain-mri-software-pixylneuro/",
"https://www.prnewswire.com/news-releases/pixyl-receives-fda-clearance-for-ai-powered-brain-mri-software-pixylneuro-301992829.html",
"https://www.auntminnie.com/clinical-news/mri/article/15658668/pixyl-receives-fda-clearance-for-ai-powered-brain-mri-software/",
"https://appliedradiology.com/articles/pixyl-nets-fda-clearance-for-ai-powered-brain-mr-software",
"https://gleamer.ai/insights/gleamer-announces-acquisitions-of-pixyl-and-caerus-medical"
],
"summary": "Automated MRI analysis software that detects, segments and quantifies white-matter hyperintensities (WMH) with longitudinal comparison and report generation.",
"description": "Pixyl.Neuro.FL is a CE- and FDA-cleared MR imaging software that automatically identifies, contours and volumetrically quantifies hyperintense brain lesions (FLAIR) and reports lesion volumes and longitudinal change; outputs include annotated DICOM sequences, structured/DICOM/PDF reports and segmentation overlays. Deployable cloud, hybrid or local and integratable into PACS and AI marketplaces; typical processing time 1–10 minutes.",
"target_users": [
"radiologists",
"neuroradiologists",
"neurologists",
"clinical researchers",
"imaging scientists",
"PACS administrators"
],
"specialties": [
"neuro",
"neuroradiology",
"multiple sclerosis",
"leukoencephalopathy",
"vascular dementia",
"small-vessel disease"
],
"regions_available": [],
"languages_supported": [],
"pricing_model": "subscription",
"pricing_details": "Subscription pricing (based on number of analyses and number of installations); contact vendor for quotes and trial information.",
"license": "commercial proprietary",
"deployment_model": [
"cloud-based",
"hybrid",
"on_prem (dedicated hardware)",
"locally virtualized (VM/Docker)"
],
"os_platforms": [
"Web",
"Windows",
"Linux"
],
"features": [
"Longitudinal analysis of serial MRIs",
"White‑matter hyperintensities (WMH) detection",
"WMH volume quantification",
"Segmentation overlays / lesion contouring",
"Annotated DICOM sequences output",
"DICOM report and PDF report generation",
"Comparison of volumes to normative percentile data",
"Change detection / lesion evolution quantification",
"Automated or on‑demand analysis triggering",
"PACS / reading‑environment integration",
"Processing time: 1–10 minutes"
],
"optional_modules": [
"Pixyl.Neuro.MS",
"Pixyl.Neuro.BV",
"PRIMUS (clinical trials / precision medicine platform)"
],
"integrations": [
"PACS (standard reading environment)",
"AI marketplace / distribution platforms",
"Blackford Analysis",
"GE Healthcare",
"Incepto",
"Siemens Healthineers",
"OEM / vendor distribution channels",
"Brainomix"
],
"data_standards": [
"DICOM"
],
"api_available": "yes",
"system_requirements": "Docker/VM or dedicated Linux server for on‑prem; internet connection for cloud deployments",
"compliance": [
"CE (MDR) Class IIa",
"FDA 510(k) clearance (Class II)"
],
"certifications": [
"CE mark (MDR) - Class IIa",
"FDA 510(k) clearance"
],
"security_features": [
"Encryption (in transit and at rest)",
"Role‑based access control (RBAC)",
"Single sign‑on (SSO) / SAML",
"Audit logs / activity logging",
"Two‑factor authentication (2FA)"
],
"privacy_features": [],
"data_residency": "",
"customers": [],
"user_reviews": [],
"ratings": [
"FDA 510(k) clearance — Pixyl.Neuro (US FDA, 2023)",
"CE marked Class IIa (MDR) — TUV Rheinland"
],
"support_channels": [
"email",
"web_portal",
"partner/ reseller support",
"community (Pixyl User Club)"
],
"training_options": [
"documentation",
"webinars",
"live_online",
"user_club / workshops"
],
"release_year": "2019",
"integration_partners": [
"GE Healthcare",
"Siemens Healthineers",
"Incepto",
"Brainomix",
"Blackford Analysis"
],
"id": "P2030",
"slug": "pixyl-neuro-fl",
"type": "product",
"version": "1.0",
"last_updated": "2025-09-07",
"links_json": {
"self": "https://www.healthaidb.com/software/pixyl-neuro-fl.json"
}
}