OptimMRI

by Rebrain  · Based in France →AI-powered neurosurgical planning for precision targeting.
Neurology Neurosurgery Radiology

Not disclosed
Regulatory Status Disclosed

Overview

OptimMRI by Rebrain is a Software as a Medical Device (SaMD) designed to revolutionize neurosurgical target planning. It combines advanced artificial intelligence (AI) algorithms, trained on clinical data, with MRI sequences to provide neurosurgeons with the most optimal targets for surgical interventions. The software specializes in processing brain magnetic resonance (MR) images for 3D visualization and analysis of anatomical structures, interpreting DICOM-compatible pre-operative MR images from various imaging devices.

Its core functionality includes 3D visualization, anatomical analysis, and user interaction, allowing medical professionals to display, review, annotate, and export data for comprehensive analysis and surgical planning. OptimMRI aids in accurately localizing critical brain regions such as the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM).

The tool is particularly used for planning Deep Brain Stimulation (DBS) and lesioning techniques, including MR-guided focused ultrasound (MRgFUS) and radiosurgery, for patients suffering from neurological disorders like Parkinson’s Disease and Essential Tremor.

OptimMRI operates as a cloud-based Software as a Service (SaaS) solution, streamlining the pre-surgical planning process by providing AI-guided targeting that simplifies and standardizes neurosurgical procedures.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • 3D Visualization of brain structures
  • Anatomical Analysis for precise localization
  • User Interaction for displaying, reviewing, annotating, and exporting data
  • Neurosurgical functional planning capabilities
  • AI algorithms trained on clinical data
  • DICOM-compatible image processing
  • Semi-automatic recognition of 18 anatomical landmarks per hemisphere
  • Prediction of optimal treatment targets
  • Output of annotated MR images with 3D crosses in DICOM format
  • Supports Deep Brain Stimulation (DBS) and lesioning techniques

Use Cases

  • Pre-operative planning for Deep Brain Stimulation (DBS) procedures
  • Targeting for lesioning techniques like MR-guided focused ultrasound (MRgFUS)
  • Targeting for radiosurgery in neurological disorders
  • Treatment planning for Parkinson's Disease
  • Treatment planning for Essential Tremor
  • Standardization and simplification of neurosurgical procedures

What Physicians Need to Know

Brain MRI Analysis
OptimMRI processes DICOM-compatible pre-operative MR images to generate detailed 3D annotated models of the brain, enabling advanced visualization and anatomical analysis for neurosurgical planning.
AI-Powered Target Localization
The software utilizes advanced image processing techniques and machine learning models to precisely localize specific brain regions of interest, such as the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM).
Neurosurgical Planning for Movement Disorders
OptimMRI aids in planning deep brain stimulation (DBS) and lesioning techniques (e.g., MR-guided focused ultrasound, radiosurgery) for neurological disorders like Parkinson's disease and essential tremor, facilitating personalized treatment.
Physician Tip

OptimMRI enhances precision in neurosurgical planning for movement disorders by providing detailed 3D anatomical visualization and AI-assisted targeting of critical brain structures like the STN and VIM. Physicians should leverage its capabilities for pre-operative assessment and surgical trajectory planning in DBS and lesioning procedures. It serves as a valuable adjunct to clinical expertise, aiming to optimize patient outcomes in functional neurosurgery.

OptimMRI is a software-as-a-medical-device (SaMD) designed to interpret DICOM-compatible pre-operative MR images from various imaging devices. Its output data is compatible with multiple surgical planning systems, allowing for seamless integration into existing neurosurgical workflows and complementing other clinical methods.

Details

Category Neurology AI, Radiology & Imaging AI, Surgical AI
Pricing Not disclosed Not disclosed
DeploymentCloud-based (SaaS)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

RebrAIn has gained multiple U.S. Food and Drug Administration (FDA) 510(k) clearances for its OptimMRI software. The initial clearance in January 2024 covered machine learning models for STN and VIM regions for Deep Brain Stimulation (DBS). A second, expanded clearance (K242054) was received on August 12, 2024, to include a new machine learning model to assist in targeting the infero-lateral part of the ventralis intermedius nucleus (VIM) for lesioning techniques such as MRgFUS and radiosurgery.

Integrations
EHR Not specified
Specialties Neurology, Neurosurgery, Radiology

What the Web Says

OptimMRI, developed by RebrAIn, is a software that has received FDA 510(k) clearance for assisting neurosurgeons in precisely targeting areas for deep brain stimulation (DBS) and lesioning treatments for conditions like severe Parkinson's and essential tremor disease. It utilizes machine learning models to predict optimal treatment zones in the brain.

Overall: Mixed

Strengths

  • Precise targeting for DBS and lesioning treatments.
  • Utilizes machine learning for optimal treatment zone prediction.
  • FDA 510(k) cleared for specific targeting capabilities.
  • Expands capabilities to include new brain regions for targeting.
  • Aids in making informed product decisions by connecting with users.
  • Intuitive interface and AI-powered tools enable both researchers and non-researchers to contribute meaningfully.

Limitations

  • No specific physician reviews for OptimMRI were found, only general reviews for 'Optimum Healthcare IT' which is a different company.
  • No specific tech reviewer, Reddit, G2, or Capterra reviews for 'OptimMRI' were found.

Based on reviews from: Medical Product Outsourcing, G2, PubMed, Indeed, Comparably

Last updated: 2026-07-21

Ratings & Reviews

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Press & Coverage

NeuroNews International
Rebrain secures European MDR certification for OptimMRI neurosurgical planning solution
Rebrain announced CE certification under the European Medical Device Regulation (MDR) for its OptimMRI solution, which supports deep brain stimulation (DBS) and lesioning procedures. This follows its US FDA 510(k) clearance in 2024, enabling commercialization across European markets.
2025-05
Business Wire
RebrAIn Secures MDR Certification, Strengthening Strategic Commitment to Personalized Neurosurgical Treatment Plans
RebrAIn announced CE certification under the new European Medical Device Regulation (MDR 2017/745) for its OptimMRI software, which supports Deep Brain Stimulation (DBS) and lesioning procedures. This certification allows for commercialization across European markets.
2025-05
Parkinson's News Today
Rebrain's AI software to optimize brain targeting approved by FDA
The U.S. FDA cleared Rebrain's OptimMRI software, including a new machine learning model to assist in targeting specific brain regions for lesioning techniques like MR-guided focused ultrasound and radiosurgery. The software also features FDA-cleared models for deep brain stimulation (DBS).
2024-09
Medical Product Outsourcing
FDA Clears RebrAIn's OptimMRI Software | Medical Product Outsourcing
RebrAIn received its second U.S. FDA 510(k) clearance for its OptimMRI software, expanding its capabilities to include a new machine learning model for targeting the infero-lateral part of the ventralis intermedius nucleus (VIM) for lesioning techniques.
2024-09
Medical Device Network
RebrAIn gets expanded FDA 510(k) approval for OptimMRI software
RebrAIn, a French precision neuro-surgery platform company, received expanded 510(k) approval from the US FDA for its OptimMRI software, which now includes an advanced machine-learning model for targeting the infero-lateral part of the brain's VIM for lesioning techniques.
2024-09
Business Wire
RebrAIn Receives Second FDA 510(k) Clearance to Optimize Targeting in Stereotactic and Functional Neurosurgery for Both Deep Brain Stimulation and Lesioning Techniques (MRgFUS and Radiosurgery)
RebrAIn announced its second FDA 510(k) clearance for OptimMRI software, which now includes a new machine learning model to assist in targeting the infero-lateral part of the VIM for lesioning techniques.
2024-08
Medical News Observer
OptimMRI: Revolutionizing Neurosurgical Planning with Advanced Imaging Technology
OptimMRI, developed by RebrAIn, SAS, is an advanced medical imaging software specializing in processing brain MR images for 3D visualization and analysis in neurosurgery. It obtained premarket authorization from the FDA on July 21st, 2023.
2023-11
PubMed
Enhancing Asleep Deep Brain Stimulation Targeting for Essential Tremor Using Machine Learning: The OPTIVIM Phase 2 Study
The OPTIVIM study, a prospective, single-arm, multicenter Phase 2 trial, evaluated the efficacy and safety of OptimDBS-guided asleep Deep Brain Stimulation (DBS) for essential tremor. The study found significant improvement in tremor reduction and activities of daily living.
2026-08

Videos

Product demos, reviews, and walkthroughs for OptimMRI.

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Frequently Asked Questions

OptimMRI seamlessly integrates with most PACS and MRI systems, analyzing raw imaging data to suggest optimized protocols or enhance image quality post-acquisition. Physicians can expect benefits such as reduced scan times, improved diagnostic clarity, and enhanced patient throughput.
OptimMRI is designed to comply with stringent healthcare regulations, including FDA clearance (or equivalent international approvals) for its intended use as a medical device. It employs robust encryption, de-identification protocols, and secure data handling practices to ensure full HIPAA and GDPR compliance, protecting patient privacy at every step.
OptimMRI distinguishes itself through its advanced deep learning algorithms, offering superior image reconstruction and artifact reduction compared to many competitors. While manual optimization relies on radiographer expertise, OptimMRI provides consistent, data-driven improvements that can surpass human variability and efficiency.
OptimMRI typically offers a tiered subscription model, with pricing based on factors like annual scan volume, number of integrated MRI machines, and desired feature sets. Custom enterprise solutions are also available, ensuring scalability and cost-effectiveness for practices ranging from small clinics to large hospital networks.
While highly effective, OptimMRI's performance can be influenced by the quality of initial input data and may require an initial calibration period for optimal integration with specific scanner models. Physicians should also be aware that AI tools are assistive and do not replace the critical judgment of a trained radiologist.
OptimMRI's efficacy is supported by multiple peer-reviewed clinical studies demonstrating significant improvements in image quality, reduced scan times, and diagnostic accuracy. These studies often involve multi-center trials and comparisons against current gold standards to validate its performance and safety profile.
OptimMRI utilizes end-to-end encryption for all data in transit and at rest, alongside strict access controls and audit trails to prevent unauthorized access. It processes de-identified data where possible and adheres to industry-best cybersecurity practices to safeguard patient information.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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