{"product_name":"Viz LVO","company_name":"Viz.ai","product_url":"https://www.viz.ai/viz-lvo","company_url":"https://www.viz.ai","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0400","summary":"Viz LVO is an AI-powered software by Viz.ai that rapidly detects large vessel occlusions in brain scans, enabling swift stroke treatment decisions.","description":"Viz LVO utilizes advanced machine learning algorithms to analyze CT angiography images, promptly identifying suspected large vessel occlusions (LVOs) in stroke patients. By integrating seamlessly into existing medical imaging systems, it facilitates real-time communication among healthcare teams, expediting diagnosis and treatment. This swift intervention is crucial, as timely treatment can significantly improve stroke outcomes. The software has been clinically validated, demonstrating a median time-to-notification of approximately 5 minutes and 45 seconds across multiple hospitals, with a sensitivity of 96% and specificity of 94% in identifying LVOs. Additionally, Viz LVO has received FDA De Novo clearance and a CE Mark, affirming its safety and efficacy for use in the U.S. and European markets. It is also eligible for Medicare reimbursement under the New Technology Add-on Payment (NTAP) program, reflecting its recognized value in improving patient outcomes. The software is available as a mobile application for iOS devices, providing healthcare professionals with on-the-go access to critical stroke information. Viz.ai, the company behind Viz LVO, is headquartered in San Francisco and Tel Aviv, with a mission to enhance healthcare delivery through intelligent software solutions.","categories":["clinical Care","diagnostic Support","patient Facing","ai Clinical Documentation Integrity","clinical Decision Support","imaging Software","healthcare It","emergency Care","neurology","telehealth","Clinical","Diagnostic","Patient-facing","Stroke Care","Artificial Intelligence","Medical Imaging","Healthcare It","Emergency Medicine","Neurology","Telemedicine"],"market_segment":["Enterprise","SMB","Consumer"],"target_users":["Clinicians","Nurses","Patients","Admins","Payers"],"specialties":["Neurology","Emergency Medicine","Radiology","Stroke Care","Telemedicine"],"regions_available":["United States","European Union","Israel"],"languages_supported":["English","Hebrew","German","French","Spanish","Italian","Dutch","Swedish","Danish","Finnish"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States","Israel"],"company_founding":"2016","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android"],"features":["Automated large vessel occlusion (LVO) detection from CT angiography","Real-time alerting and clinician notification/triage","Mobile and web image viewer with HIPAA-compliant sharing","Interactive AI-enhanced 3D CTA visualization (Viz 3D CTA)","Case review and coordinated care communication (care team chat/annotations)","Automated workflow orchestration for transfers and EVT routing","Integration with radiology workflow/PACS for automated image ingestion","Transfer decision support and hub-and-spoke coordination","Clinical analytics and performance metrics reporting","Automated prioritization and routing to on-call specialists","Support for multi-site/hospital network deployments"],"optional_modules":["Viz 3D CTA","Clinical analytics and performance metrics reporting"],"integrations":["Epic","Cerner (Oracle Cerner)","PACS (modalities via DICOM)","VNA (vendor neutral archive)","EHR systems (general integrations via HL7/FHIR)","Microsoft Cloud for Healthcare","Mobile push/notification services","On-call/phone systems for clinician notification"],"data_standards":["DICOM","HL7 v2","FHIR"],"api_available":"yes","system_requirements":"Major OS/DB/hardware needs, or empty if SaaS-only","compliance":["HIPAA","HITECH","GDPR","SOC 2","ISO 27001:2022","ISO 22301:2019","ISO 27017:2015","ISO 27018:2019","ISO 27032:2012","ISO 27701:2019","ISO 27799:2016"],"certifications":["FDA De Novo clearance (Viz LVO DEN170073)","CE Marked (MDD Class I)"],"security_features":["Data encryption in transit and at rest","Role-based access control (RBAC)","SSO/SAML support","Audit logging","Multi-factor authentication (2FA)"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US and EU hosting options (regional cloud deployment choices)","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"\"\"","integration_partners":[],"id":"SW0400","slug":"viz-lvo","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/viz-lvo.json"}}