JSON twin: https://www.healthaidb.com/software/trace4ad.json
DeepTrace Technologies
https://www.deeptracetech.com/en/products/trace4ad
https://www.deeptracetech.com/en/
TRACE4AD is a CE‑cleared AI software that analyzes 3D T1 brain MRI (optionally with neuropsychological data) to provide a subject‑level low vs high risk prediction of progression to Alzheimer's disease dementia within 24 months.
TRACE4AD (DeepTrace) is a commercial, CE‑marked software-as-a-medical-device that automatically processes 3D T1-weighted brain MRI (MP‑RAGE) and optional cognitive/functional/behavioral measures to (1) compute gray matter volumes and normative comparisons, (2) generate voxel‑based predictor maps, and (3) output a binary risk score (low vs high) for conversion/progression to Alzheimer's disease dementia within 24 months. Outputs are delivered as reports (PDF) and the product can be deployed cloud‑based or locally; intended as a diagnostic/prognostic support tool for neurology and neuroradiology specialists.
unknown
2018
P2003
2025-09-07
commercial, proprietary
Tiered subscription (priced by number of analyses / installations / users); contact vendor for public pricing and trial information.
subscription
2021
product
1.0
{
"company_name": "DeepTrace Technologies",
"company_url": "https://www.deeptracetech.com/en/",
"company_offices": [
"Italy"
],
"company_founding": "2018",
"product_url": "https://www.deeptracetech.com/en/products/trace4ad",
"categories": [
"clinical",
"diagnostic",
"imaging",
"prognostic",
"neuro"
],
"market_segment": [
"enterprise",
"smb"
],
"links": [
"https://www.deeptracetech.com/en/products/trace4ad",
"https://www.deeptracetech.com/en/",
"https://www.deeptracetech.com/en/contacts",
"https://trace4ad.deeptrace.tech/",
"https://www.deeptracetech.com/en/download/product/1/product-sheet",
"https://healthairegister.com/products/deeptrace-trace4ad",
"https://www.deeptracetech.com/en/news-room/deeptrace-technologies-announces-ce-mark-and-european-launch-of-trace4ad-the-medical-device-for-the-early-diagnosis-and-prognosis-of-alzheimer-s-disease",
"https://www.deeptracetech.com/en/publications"
],
"summary": "TRACE4AD is a CE‑cleared AI software that analyzes 3D T1 brain MRI (optionally with neuropsychological data) to provide a subject‑level low vs high risk prediction of progression to Alzheimer's disease dementia within 24 months.",
"description": "TRACE4AD (DeepTrace) is a commercial, CE‑marked software-as-a-medical-device that automatically processes 3D T1-weighted brain MRI (MP‑RAGE) and optional cognitive/functional/behavioral measures to (1) compute gray matter volumes and normative comparisons, (2) generate voxel‑based predictor maps, and (3) output a binary risk score (low vs high) for conversion/progression to Alzheimer's disease dementia within 24 months. Outputs are delivered as reports (PDF) and the product can be deployed cloud‑based or locally; intended as a diagnostic/prognostic support tool for neurology and neuroradiology specialists.",
"target_users": [
"neurologists",
"neuroradiologists",
"radiologists",
"referring physicians",
"clinical researchers",
"imaging specialists"
],
"specialties": [
"neurology",
"neuroradiology",
"geriatrics",
"memory clinic"
],
"regions_available": [
"European Union",
"Italy"
],
"languages_supported": [
"English",
"Italian"
],
"pricing_model": "subscription",
"pricing_details": "Tiered subscription (priced by number of analyses / installations / users); contact vendor for public pricing and trial information.",
"license": "commercial, proprietary",
"deployment_model": [
"cloud",
"SaaS"
],
"os_platforms": [
"Web"
],
"features": [
"Automatic T1-weighted brain MRI preprocessing (re-orientation, cropping, skull-stripping, normalization to MNI)",
"Automated volumetric segmentation and regional brain volumes (hippocampus, lobes, precuneus, etc.)",
"Voxel-based atrophy maps / explainability maps highlighting regions contributing to classification",
"Ensemble SVM-based machine learning classifier for staging (HS/MCI/MD/MSD)",
"Individual subject 24-month risk prediction for progression to Alzheimer's dementia (low risk / high risk)",
"Integration of neuropsychological test scores into combined MRI+clinical classification",
"Automatic report generation with cognitive deficits, volumetrics and risk score",
"PACS integration / automated MRI ingestion",
"Support for training and onboarding, remote training verification",
"Remote-controlled software updates and customer support",
"Comparative output for clinical profiling (typical/atypical AD, PPA variants, bvFTD/fvAD)",
"Quantitative outputs for longitudinal tracking and disease progression"
],
"optional_modules": [
"Trace4Research",
"Trace4DigitalTwin",
"Other DeepTrace modules (TRACE4BUS, TRACE4OC) as complementary offerings"
],
"integrations": [
"PACS (full PACS integration for automated MRI receipt)",
"RIS (radiology workflow systems via imaging interfaces / reports)",
"EHR (clinical reports ingestion/export via standard clinical report formats)"
],
"data_standards": [
"DICOM"
],
"api_available": "unknown",
"system_requirements": "",
"compliance": [
"CE (medical device - CE-cleared)",
"ISO 13485 (manufacturer quality management)",
"GDPR (EU Regulation 2016/679)",
"EU AI Act (Regulation 2024/1689)",
"IEC 81001-5-1:2021 (health software security lifecycle)",
"BS AAMI 34971:2023 (medical device cybersecurity guidance)",
"MDCG 2019-16"
],
"certifications": [
"CE mark",
"ISO 13485"
],
"security_features": [
"Encryption (manufacturer declares adherence to security standards)",
"Audit logs",
"Role-based access control (RBAC)",
"Secure, remotely controlled updates"
],
"privacy_features": [
"GDPR-aligned privacy policy",
"Privacy/data protection documentation and eIFU distribution process"
],
"data_residency": "",
"customers": [],
"user_reviews": [],
"ratings": [],
"support_channels": [
"email",
"contact form",
"book a meeting / online scheduling",
"customer care portal",
"documentation / eIFU download"
],
"training_options": [
"documentation",
"product sheet / eIFU",
"webinars",
"live_online training",
"onsite training"
],
"release_year": "2021",
"integration_partners": [
"Romion Health"
],
"id": "P2003",
"slug": "trace4ad",
"type": "product",
"version": "1.0",
"last_updated": "2025-09-07",
"links_json": {
"self": "https://www.healthaidb.com/software/trace4ad.json"
}
}