{"product_name":"Ahead 300","company_name":"BrainScope","product_url":"https://www.brainscope.com/products","company_url":"https://www.brainscope.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0620","summary":"The Ahead 300 is a handheld medical device developed by BrainScope for rapid, objective assessment of traumatic brain injury (TBI), including concussion, at the point of care.","description":"The Ahead 300 utilizes electroencephalography (EEG) technology, advanced signal processing, and machine learning to evaluate head-injured patients. It offers a comprehensive panel of assessments to assist clinicians in diagnosing the full spectrum of TBI, from structural injuries to mild concussions. Developed in partnership with the U.S. Department of Defense, the device is intended for use in emergency departments, urgent care centers, concussion clinics, and military healthcare settings. It aims to reduce unnecessary CT scans, decrease patient length of stay, and improve patient triage and management.","categories":["diagnostic Support","clinical Care","patient Facing","Diagnostic","Clinical","Patient-facing"],"market_segment":["enterprise","consumer"],"target_users":["clinicians","patients","admins"],"specialties":["Neurology","Emergency Medicine","Sports Medicine","Military Medicine"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"enterprise_quote","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States"],"company_founding":"2010","deployment_model":["on_prem","hybrid"],"os_platforms":["Windows","macOS","Linux"],"features":["Handheld device for assessing traumatic brain injury (TBI)","Electroencephalography (EEG) capabilities","Advanced signal processing algorithms","Machine learning for brain electrical activity analysis","Rapid, objective assessment of head-injured patients","Multi-modal assessment panel","Configurable test options","Integration with electronic medical records (EMR)","FDA-cleared medical device","Developed in partnership with the U.S. Department of Defense","Over 20 clinical studies at 55 sites","16 peer-reviewed publications supporting efficacy"],"optional_modules":["Concussion Index (CI)","Brain Function Index (BFI)","Structural Injury Classifier (SIC)"],"integrations":["Electronic Medical Records (EMR) systems"],"data_standards":["HL7","DICOM"],"api_available":"unknown","system_requirements":"Windows, macOS, Linux","compliance":["HIPAA","FDA 510(k) clearance","ISO 13485:2003 Certification"],"certifications":["FDA 510(k) clearance","ISO 13485:2003 Certification"],"security_features":["Data encryption","Role-based access control (RBAC)","Audit logs"],"privacy_features":["Data anonymization","Data minimization"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"\"\"","integration_partners":[],"id":"SW0620","slug":"ahead-300","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/ahead-300.json"}}