JSON twin: https://www.healthaidb.com/software/aimify.json
Bracco Diagnostics
AiMIFY is an AI-powered medical imaging software that enhances contrast and lesion conspicuity on brain MRI scans to improve diagnostic clarity and workflow efficiency.
AiMIFY (Bracco + Subtle Medical) is a cleared/CE‑marked image‑processing software that uses deep learning to amplify contrast enhancement on contrast‑enhanced brain MRI (increasing contrast‑to‑noise and lesion conspicuity, reported up to ~2x). It is delivered as a vendor‑neutral software solution that operates on routine MR acquisitions without hardware changes, integrates into imaging workflows (DICOM/PACS), and is marketed for clinical use following regulatory clearances (FDA, CE).
yes
1927
P1903
2025-09-07
commercial, proprietary
Contact vendor for pricing, deployment and licensing options (commercial/enterprise agreements); trial/POC availability: contact vendor.
enterprise_quote
2024
DICOM-compatible PACS; internet connection for cloud; on-prem server with sufficient CPU/GPU for image processing; storage for DICOM images
product
1.0
{
"company_name": "Bracco Diagnostics",
"company_url": "https://www.bracco.com",
"company_offices": [
"Italy",
"United States",
"Canada",
"United Kingdom",
"Germany"
],
"company_founding": "1927",
"product_url": "https://braccomr.com/aimify/",
"categories": [
"diagnostic",
"imaging",
"radiology",
"clinical",
"AI/ML"
],
"market_segment": [
"enterprise",
"hospital"
],
"links": [
"https://braccomr.com/aimify/",
"https://www.bracco.com/en-ca/article/bracco-diagnostics-and-subtle-medical-announce-fda-clearance-aimifytm-software",
"https://www.bracco.com/article/ce-mark-aimifytm-software-enhanced-mri-europe",
"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240290",
"https://subtlemedical.com/news/",
"https://www.prnewswire.com/news-releases/bracco-diagnostics-inc-and-subtle-medical-announce-fda-clearance-of-aimify-software-for-enhanced-mri-302277136.html",
"https://www.auntminnie.com/clinical-news/mri/article/15706017/fda-clears-ai-software-from-bracco-subtle-medical",
"https://www.diagnosticimaging.com/view/fda-clears-emerging-ai-powered-software-for-brain-mri"
],
"summary": "AiMIFY is an AI-powered medical imaging software that enhances contrast and lesion conspicuity on brain MRI scans to improve diagnostic clarity and workflow efficiency.",
"description": "AiMIFY (Bracco + Subtle Medical) is a cleared/CE‑marked image‑processing software that uses deep learning to amplify contrast enhancement on contrast‑enhanced brain MRI (increasing contrast‑to‑noise and lesion conspicuity, reported up to ~2x). It is delivered as a vendor‑neutral software solution that operates on routine MR acquisitions without hardware changes, integrates into imaging workflows (DICOM/PACS), and is marketed for clinical use following regulatory clearances (FDA, CE).",
"target_users": [
"radiologists",
"neuroradiologists",
"MRI technologists",
"radiology departments",
"imaging center administrators"
],
"specialties": [
"neuroradiology",
"diagnostic radiology",
"neuro-oncology",
"neurovascular"
],
"regions_available": [
"United States",
"European Union",
"United Kingdom",
"Global (via Bracco/Subtle Medical distribution)"
],
"languages_supported": [
"English"
],
"pricing_model": "enterprise_quote",
"pricing_details": "Contact vendor for pricing, deployment and licensing options (commercial/enterprise agreements); trial/POC availability: contact vendor.",
"license": "commercial, proprietary",
"deployment_model": [
"cloud (SaaS)",
"on_premise",
"hybrid"
],
"os_platforms": [
"server (Linux)",
"server (Windows)",
"PACS workstation integration",
"web (for cloud management)"
],
"features": [
"AI-based contrast amplification for brain MRI (pre/post-contrast)",
"Selective lesion visualization amplification (up to ~2x visibility)",
"Post-acquisition processing (retrospective processing)",
"DICOM-compliant processing and interoperability with PACS",
"Supports 2D and 3D T1-weighted sequences (FLAIR, FSE, BRAVO, MPRAGE)",
"Improves contrast-to-noise ratio (CNR) and contrast enhancement percentage (CEP)",
"Enhances lesion-to-brain ratio and border delineation",
"Preserves internal morphology moderately with window/level adjustments",
"Supports scans from 0.3T, 1.5T and 3.0T scanners",
"Works with images acquired across axial/coronal/sagittal orientations",
"No end-user GUI (processing runs in background/platform)",
"Can reduce need for re-scans by enhancing existing images",
"Intended for patients aged 7–86 (validated age range)",
"Processed images intended to be reviewed alongside standard post-contrast images",
"Complies with FDA cybersecurity guidance for medical software"
],
"optional_modules": [],
"integrations": [
"PACS (DICOM workflows)",
"GE Healthcare MRI scanners (tested models)",
"Siemens Healthineers MRI scanners (tested models)",
"Philips MRI scanners (tested models)",
"Hitachi MRI scanners (tested models)"
],
"data_standards": [
"DICOM"
],
"api_available": "yes",
"system_requirements": "DICOM-compatible PACS; internet connection for cloud; on-prem server with sufficient CPU/GPU for image processing; storage for DICOM images",
"compliance": [
"FDA (Class II software) guidance",
"HIPAA (applicable to US deployments)",
"GDPR (applicable to EU data)"
],
"certifications": [
"FDA 510(k) clearance (K240290)"
],
"security_features": [
"encryption in transit and at rest",
"audit logging",
"role-based access control (RBAC)",
"compliance with FDA cybersecurity guidance"
],
"privacy_features": [],
"data_residency": "",
"customers": [],
"user_reviews": [],
"ratings": [
"FDA clearance (K240290) - U.S. Food and Drug Administration",
"CE Mark - European Conformity"
],
"support_channels": [],
"training_options": [
"documentation"
],
"release_year": "2024",
"integration_partners": [
"Subtle Medical",
"Bracco Imaging / Bracco Diagnostics"
],
"id": "P1903",
"slug": "aimify",
"type": "product",
"version": "1.0",
"last_updated": "2025-09-07",
"links_json": {
"self": "https://www.healthaidb.com/software/aimify.json"
}
}