AiMIFY

JSON twin: https://www.healthaidb.com/software/aimify.json

Company Name

Subtle Medical

Product URL

https://subtlemedical.com/aimify

Company URL

https://subtlemedical.com

Categories

• diagnostic Support
• clinical Care
• radiology
• imaging Software
• ai Clinical Documentation Integrity
• Diagnostic
• Clinical
• Imaging Enhancement
• Ai-powered Software

Summary

AiMIFY is an AI-powered software that enhances brain MRI images, improving lesion detection and diagnostic precision.

Description

AiMIFY utilizes advanced AI technology to amplify contrast in brain MRI scans, achieving up to twice the enhancement of standard gadolinium-based contrast agents. This enhancement aids radiologists in detecting small and poorly enhanced lesions, thereby improving diagnostic accuracy. The software has been validated across diverse patient demographics, pathologies, lesion sizes, MRI sequences, and scanner vendors, demonstrating its versatility and effectiveness. AiMIFY received FDA clearance as a Class II software as a medical device for brain MRI in October 2024 and the CE Mark in June 2025, confirming its compliance with European safety and health standards. It integrates seamlessly with existing MRI workflows, requiring no additional hardware or significant procedural changes. The software is designed to be vendor-neutral, compatible with various MRI scanners, and operates as a post-processing tool without a user interface, integrating with PACS via DICOM. Its performance has been quantitatively and qualitatively validated, showing significant improvements in contrast-to-noise ratio, contrast enhancement percentage, and lesion-to-brain ratio compared to standard post-contrast images. Qualitative studies with board-certified neuroradiologists have demonstrated enhanced lesion contrast, border delineation, and internal morphology visibility, supporting its clinical utility in routine practice.

Api Available

yes

Certifications

• FDA 510(k) clearance (K240290)
• CE Mark - European Conformity

Company Founding

2018

Company Offices

• United States
• Italy

Compliance

• FDA (Class II software) guidance
• HIPAA (applicable to US deployments)
• GDPR (applicable to EU data)

Customers

Data Residency

US/EU regions

Data Standards

• DICOM

Deployment Model

• cloud (SaaS)
• on_premise
• hybrid

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

Id

SW0177

Integration Partners

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)

Languages Supported

• English
• Italian

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

Os Platforms

• server (Linux)
• server (Windows)
• PACS workstation integration
• web (for cloud management)

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• consent management
• anonymization
• data minimization

Product Code

SW0177

Product Name

AiMIFY

Ratings

Regions Available

• United States
• European Union

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• encryption in transit and at rest
• audit logging
• role-based access control (RBAC)
• compliance with FDA cybersecurity guidance

Specialties

• Neurology
• Radiology
• Neuroimaging

Support Channels

System Requirements

DICOM-compatible PACS; internet connection for cloud; on-prem server with sufficient CPU/GPU for image processing; storage for DICOM images

Target Users

• radiologists
• neuroradiologists
• clinicians
• medical imaging professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "AiMIFY",
  "company_name": "Subtle Medical",
  "product_url": "https://subtlemedical.com/aimify",
  "company_url": "https://subtlemedical.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0177",
  "summary": "AiMIFY is an AI-powered software that enhances brain MRI images, improving lesion detection and diagnostic precision.",
  "description": "AiMIFY utilizes advanced AI technology to amplify contrast in brain MRI scans, achieving up to twice the enhancement of standard gadolinium-based contrast agents. This enhancement aids radiologists in detecting small and poorly enhanced lesions, thereby improving diagnostic accuracy. The software has been validated across diverse patient demographics, pathologies, lesion sizes, MRI sequences, and scanner vendors, demonstrating its versatility and effectiveness. AiMIFY received FDA clearance as a Class II software as a medical device for brain MRI in October 2024 and the CE Mark in June 2025, confirming its compliance with European safety and health standards. It integrates seamlessly with existing MRI workflows, requiring no additional hardware or significant procedural changes. The software is designed to be vendor-neutral, compatible with various MRI scanners, and operates as a post-processing tool without a user interface, integrating with PACS via DICOM. Its performance has been quantitatively and qualitatively validated, showing significant improvements in contrast-to-noise ratio, contrast enhancement percentage, and lesion-to-brain ratio compared to standard post-contrast images. Qualitative studies with board-certified neuroradiologists have demonstrated enhanced lesion contrast, border delineation, and internal morphology visibility, supporting its clinical utility in routine practice.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "radiology",
    "imaging Software",
    "ai Clinical Documentation Integrity",
    "Diagnostic",
    "Clinical",
    "Radiology",
    "Imaging Enhancement",
    "Ai-powered Software"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "radiologists",
    "neuroradiologists",
    "clinicians",
    "medical imaging professionals"
  ],
  "specialties": [
    "Neurology",
    "Radiology",
    "Neuroimaging"
  ],
  "regions_available": [
    "United States",
    "European Union"
  ],
  "languages_supported": [
    "English",
    "Italian"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Italy"
  ],
  "company_founding": "2018",
  "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)",
    "CE Mark - European Conformity"
  ],
  "security_features": [
    "encryption in transit and at rest",
    "audit logging",
    "role-based access control (RBAC)",
    "compliance with FDA cybersecurity guidance"
  ],
  "privacy_features": [
    "BAA available",
    "consent management",
    "anonymization",
    "data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0177",
  "slug": "aimify",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/aimify.json"
  }
}