{"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"}}