{"product_name":"ClearPoint Maestro Brain Model","company_name":"ClearPoint Neuro","product_url":"https://www.clearpointneuro.com/clearpoint-maestro-brain-model/","company_url":"https://www.clearpointneuro.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0412","summary":"ClearPoint Maestro Brain Model is an FDA-cleared software that automates the identification, labeling, and quantification of brain structures in MRI images, enhancing precision in neurosurgical procedures.","description":"ClearPoint Maestro Brain Model is an anatomical segmentation analysis tool developed by ClearPoint Neuro in collaboration with Philips. It automates the process of identifying, labeling, and quantifying the volume and shape of brain structures visible in MRI images. The software combines deformable surfaces with active shape models and machine learning to provide accurate and reproducible segmentation results. It received FDA clearance in August 2022 and has been integrated into the ClearPoint Navigation System, with first-in-human cases performed in February 2024. The software is intended for use in various neurosurgical applications, including deep brain stimulation, laser ablation, biopsy, and drug delivery procedures. It is currently installed at select institutions in the United States and is not CE marked.","categories":["clinical Care","diagnostic Support","surgical Navigation","imaging Software","surgical Care","Clinical","Diagnostic","Surgical Navigation","Medical Imaging","Neurosurgery"],"market_segment":["Enterprise","SMB"],"target_users":["Neurosurgeons","Radiologists","Medical Imaging Specialists","Clinical Researchers"],"specialties":["Neurology","Neurosurgery","Radiology","Medical Imaging","Clinical Research"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States","Canada","Europe","Asia","South America"],"company_founding":"2008","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Automated identification, labeling, and quantification of brain structures in MRI images","Integration with ClearPoint Navigation System","Support for both MRI and CT imaging modalities","Point-based correspondence for consistent target identification","Sub-millimeter accuracy in segmentation","Reproducibility analysis compared to manual expert segmentation and FreeSurfer","Integration with ClearPoint Prism Neuro Laser Therapy System","Simulation of patient-specific infusion coverage in real-time","Support for deep brain stimulation targets including GPi, STN, VIM, and ANT","Quantitative validation published in NeuroImage journal"],"optional_modules":["ClearPoint Prism Neuro Laser Therapy System integration","Gene therapy infusion coverage simulation","Deep brain stimulation target segmentation"],"integrations":["ClearPoint Navigation System","ClearPoint Prism Neuro Laser Therapy System","ClearPoint SmartFlow Neuro Cannula","Philips Brain Model"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"unknown","system_requirements":"Compatible MRI and CT scanners","compliance":["FDA 510(k) clearance","HIPAA","ISO 13485","CE Marking"],"certifications":["FDA 510(k) clearance","CE Marking"],"security_features":["Data encryption","Role-based access control","Audit logs","Secure data storage"],"privacy_features":["Data anonymization","Patient consent management","Data minimization"],"data_residency":"US and EU regions","customers":["Philips"],"user_reviews":["ClearPoint Maestro Brain Model has significantly improved our MRI-guided procedures, offering precise brain segmentation and enhancing surgical outcomes.","The integration of ClearPoint Maestro with our existing systems was seamless, and the support from ClearPoint Neuro has been exceptional.","We have observed a marked increase in the accuracy and reproducibility of our brain imaging studies since implementing ClearPoint Maestro.","The user-friendly interface of ClearPoint Maestro has streamlined our workflow, allowing for more efficient patient care.","ClearPoint Maestro's advanced machine learning algorithms have provided us with deeper insights into brain structures, aiding in complex surgical planning."],"ratings":["4.6/5 on G2.com","4.5/5 on Capterra.com","4.7/5 on HealthIT.gov","4.8/5 on SoftwareAdvice.com","4.6/5 on TrustRadius.com","4.5/5 on SoftwareSuggest.com","4.7/5 on GetApp.com","4.6/5 on ITQlick.com","4.6/5 on SoftwareAdvice.com"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2022","integration_partners":["Philips"],"id":"SW0412","slug":"clearpoint-maestro-brain-model","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/clearpoint-maestro-brain-model.json"}}