{"product_name":"BoneView","company_name":"Gleamer","product_url":"https://www.gleamer.ai/solutions/boneview","company_url":"https://www.gleamer.ai","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0379","summary":"BoneView is an AI-powered software developed by Gleamer to assist healthcare professionals in detecting and localizing fractures in X-ray images, enhancing diagnostic accuracy and efficiency.","description":"BoneView utilizes advanced artificial intelligence algorithms to analyze X-ray images, identifying potential fractures and presenting them to radiologists for validation. This process aims to reduce diagnostic errors, improve reading times, and support clinicians in delivering accurate patient care. The software has received FDA clearance for use in the United States and CE mark class 2a certification in Europe, indicating its compliance with regulatory standards. It is deployed in over 2,500 public and private institutions across more than 45 countries, with over 40 million exams processed annually. Clinical studies have demonstrated that BoneView can improve fracture detection sensitivity by 10.4% and reduce reading time by 6.3 seconds per patient. Additionally, it has been shown to decrease the false negative rate by 29% and reduce reading time by 15% on challenging exams. The software is available in the U.S. through Gleamer and other platforms, including Fujifilm, Aidoc, Ferrum Health, and Blackford Analysis.","categories":["clinical Care","diagnostic Support","radiology","imaging Software","clinical Decision Support","Clinical","Diagnostic","Radiology","Ai-assisted Imaging"],"market_segment":["enterprise","smb"],"target_users":["radiologists","orthopedic surgeons","emergency physicians","rheumatologists","family physicians","physician assistants"],"specialties":["Orthopedics","Emergency Medicine","Rheumatology","Family Medicine"],"regions_available":["United States","France","Germany","Spain","United Kingdom","Italy","Netherlands","Belgium","Switzerland","Austria","Australia","Japan","South Korea","China","India","Brazil","Mexico","Canada","South Africa","United Arab Emirates"],"languages_supported":["English","French","German","Spanish","Italian","Dutch","Portuguese","Japanese","Korean","Chinese","Hindi","Arabic","Russian","Turkish","Polish","Swedish","Norwegian","Danish","Finnish","Greek"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["France","United States","Germany","Spain","United Kingdom","Italy","Netherlands","Belgium","Switzerland","Austria"],"company_founding":"2017","deployment_model":["SaaS","on_prem","cloud_hosted"],"os_platforms":["Web","Windows","macOS","Linux"],"features":["Automated fracture detection on X-rays","Lesion localization and heatmap overlays","Prioritization/triage of urgent exams","Inline reading support within PACS/viewer workflow","Per-image and per-study confidence scores","Batch processing / worklist flagging","Visualization of AI findings in viewer","Clinical evidence and reporting support"],"optional_modules":["EOS acquisition support","Integration gateway for PACS orchestration","Integration with Gleamer BoneView suite (other BoneView modules)"],"integrations":["PACS (vendor-neutral integrations)","RIS / Reporting systems","Ferrum Health AI platform","Aidoc (partner workflows)","Sectra Amplifier (marketplace)","Konica Minolta","Microsoft AppSource (viewer integration)","Incepto Gateway (PACS integration/orchestration)","Gleamer BoneView ecosystem (other BoneView modules)"],"data_standards":["DICOM","HL7 v2","FHIR"],"api_available":"yes","system_requirements":"DICOM-capable PACS/viewer; optional on-prem server (Linux/Windows); network access to PACS/HIS","compliance":["CE (EU)","FDA cleared (US)","GDPR","HIPAA (suitable for HIPAA environments)"],"certifications":["CE marking","FDA 510(k) clearance"],"security_features":["Data encryption in transit and at rest","Role-based access control (RBAC)","SSO/SAML support","Audit logging"],"privacy_features":["GDPR compliance","Data anonymization options"],"data_residency":"Cloud hosting options in EU and US (regional hosting available); on-prem deployment supported","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0379","slug":"boneview","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/boneview.json"}}