{"product_name":"BrainInsight","company_name":"Hyperfine","product_url":"https://hyperfinemri.com","company_url":"https://hyperfinemri.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0393","summary":"BrainInsight is an AI-powered software developed by Hyperfine that enhances MRI imaging by automating post-processing tasks, including labeling, spatial measurement, and volumetric quantification of brain structures, thereby improving diagnostic efficiency and accuracy.","description":"BrainInsight is a fully automated MRI post-processing software developed by Hyperfine, Inc. It is classified by the FDA as a Class II medical device and received 510(k) marketing clearance in January 2021. The software is designed for automatic labeling, spatial measurement, and volumetric quantification of brain structures from low-field MR images, providing annotated and segmented images, color overlays, and reports. In December 2022, Hyperfine received clearance to include pediatric patients aged two years and older for lateral ventricles and midline shift applications. Additionally, in December 2022, Hyperfine received clearance for modifications to the MRI system, including software modifications related to device pulse sequences and retraining of advanced reconstruction models.","categories":["clinical Care","diagnostic Support","imaging Software","software Development","Clinical","Diagnostic","Imaging","Software"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","neurologists","neurosurgeons","pediatricians"],"specialties":["Neurology","Neurosurgery","Pediatrics","Radiology"],"regions_available":["United States","Canada","European Union","United Kingdom","Australia","New Zealand","Pakistan"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States","United Kingdom","Australia","New Zealand","Pakistan"],"company_founding":"2014","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["AI-powered portable brain MRI","Diagnostic-quality imaging","Rapid setup and operation","Open design for patient comfort","No ionizing radiation exposure","FDA-cleared for pediatric patients aged two years and older","Automatic labeling of brain structures","Spatial measurement and volumetric quantification","Annotated and segmented images","Color overlays and reports"],"optional_modules":["Advanced reconstruction models","Pediatric imaging applications"],"integrations":["Swoop® system","Optive AI™ software"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"unknown","system_requirements":"N/A","compliance":["HIPAA","FDA 510(k)","ISO 27001","SOC 2","GDPR"],"certifications":["FDA 510(k)","CE/MDR","ISO 27001","SOC 2","GDPR"],"security_features":["End-to-end encryption","Role-based access control","Audit logs","2FA","Data loss prevention"],"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":"SW0393","slug":"braininsight","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/braininsight.json"}}