OptimMRI

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

Company Name

RebrAIn

Product URL

https://rebrain.eu/optimMRI

Company URL

https://rebrain.eu/

Categories

• clinical Care
• diagnostic Support
• patient Facing
• Clinical
• Diagnostic

Summary

OptimMRI is an AI-driven surgical planning platform developed by RebrAIn, designed to enhance precision in neurosurgical procedures for movement disorders.

Description

OptimMRI leverages advanced machine learning algorithms to process MRI scans, assisting neurosurgeons in accurately targeting brain regions such as the subthalamic nucleus (STN) and ventralis intermedius nucleus (VIM) for treatments like Deep Brain Stimulation (DBS) and lesioning techniques (HIFU and radiosurgery). The software has received FDA 510(k) clearance and CE marking under the European Medical Device Regulation (MDR), validating its safety and efficacy in clinical settings. RebrAIn, a France-based medtech company, offers this solution to improve surgical outcomes for patients with Parkinson's disease and essential tremor.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• CE marking under MDR 2017/745
• ISO 13485:2016
• MDR 2017/745

Company Founding

2019

Company Offices

• France
• United States

Compliance

• HIPAA
• GDPR
• ISO 13485:2016
• MDR 2017/745
• FDA 510(k) clearance

Customers

Data Residency

EU-only

Data Standards

• DICOM
• HL7
• FHIR
• SNOMED CT
• ICD-10

Deployment Model

• SaaS

Features

• AI-driven MRI-guided targeting for neurosurgical procedures
• Automated identification of brain regions for Deep Brain Stimulation (DBS) and lesioning techniques
• Integration with existing neurosurgical workflows
• Enhanced precision in targeting subthalamic nucleus (STN) and ventralis intermedius nucleus (VIM)
• FDA 510(k) clearance for DBS procedures
• CE marking under MDR 2017/745 for European markets
• Secure health data exchange compliant with GDPR
• Cloud-based processing with data hosted on Health Data Hosting (HDS) certified servers
• Semi-automatic recognition of 18 anatomical brain structures per side
• Collaboration with trained neurosurgical professionals for MRI verification

Id

SW0184

Integration Partners

Integrations

• MRI systems
• Neurosurgical planning software
• Health Data Hosting (HDS) certified servers

Languages Supported

• English
• French

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• OptimDBS
• OptimDBS Lesioning

Os Platforms

• Web

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• Health data exchange compliant with GDPR
• Data anonymization
• Data minimization

Product Code

SW0184

Product Name

OptimMRI

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

• End-to-end encryption
• Role-based access control (RBAC)
• Audit logs
• Secure health data exchange compliant with GDPR

Specialties

• Neurology
• Neurosurgery
• Movement Disorders

Support Channels

System Requirements

Target Users

• clinicians
• neurosurgeons
• patients

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "OptimMRI",
  "company_name": "RebrAIn",
  "product_url": "https://rebrain.eu/optimMRI",
  "company_url": "https://rebrain.eu/",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0184",
  "summary": "OptimMRI is an AI-driven surgical planning platform developed by RebrAIn, designed to enhance precision in neurosurgical procedures for movement disorders.",
  "description": "OptimMRI leverages advanced machine learning algorithms to process MRI scans, assisting neurosurgeons in accurately targeting brain regions such as the subthalamic nucleus (STN) and ventralis intermedius nucleus (VIM) for treatments like Deep Brain Stimulation (DBS) and lesioning techniques (HIFU and radiosurgery). The software has received FDA 510(k) clearance and CE marking under the European Medical Device Regulation (MDR), validating its safety and efficacy in clinical settings. RebrAIn, a France-based medtech company, offers this solution to improve surgical outcomes for patients with Parkinson's disease and essential tremor.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "neurosurgeons",
    "patients"
  ],
  "specialties": [
    "Neurology",
    "Neurosurgery",
    "Movement Disorders"
  ],
  "regions_available": [
    "United States",
    "European Union"
  ],
  "languages_supported": [
    "English",
    "French"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "France",
    "United States"
  ],
  "company_founding": "2019",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "AI-driven MRI-guided targeting for neurosurgical procedures",
    "Automated identification of brain regions for Deep Brain Stimulation (DBS) and lesioning techniques",
    "Integration with existing neurosurgical workflows",
    "Enhanced precision in targeting subthalamic nucleus (STN) and ventralis intermedius nucleus (VIM)",
    "FDA 510(k) clearance for DBS procedures",
    "CE marking under MDR 2017/745 for European markets",
    "Secure health data exchange compliant with GDPR",
    "Cloud-based processing with data hosted on Health Data Hosting (HDS) certified servers",
    "Semi-automatic recognition of 18 anatomical brain structures per side",
    "Collaboration with trained neurosurgical professionals for MRI verification"
  ],
  "optional_modules": [
    "OptimDBS",
    "OptimDBS Lesioning"
  ],
  "integrations": [
    "MRI systems",
    "Neurosurgical planning software",
    "Health Data Hosting (HDS) certified servers"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR",
    "SNOMED CT",
    "ICD-10"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "GDPR",
    "ISO 13485:2016",
    "MDR 2017/745",
    "FDA 510(k) clearance"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE marking under MDR 2017/745",
    "ISO 13485:2016",
    "MDR 2017/745"
  ],
  "security_features": [
    "End-to-end encryption",
    "Role-based access control (RBAC)",
    "Audit logs",
    "Secure health data exchange compliant with GDPR"
  ],
  "privacy_features": [
    "Health data exchange compliant with GDPR",
    "Data anonymization",
    "Data minimization"
  ],
  "data_residency": "EU-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0184",
  "slug": "optimmri",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/optimmri.json"
  }
}