{"product_name":"Rho","company_name":"16 Bit","product_url":"https://www.16bit.ai/rho","company_url":"https://www.16bit.ai","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0232","summary":"Rho is an AI-driven software that analyzes routine X-rays to identify patients at risk of low bone mineral density, aiding in early osteoporosis detection and management.","description":"Rho utilizes standard X-rays to opportunistically screen for low bone mineral density (BMD) in patients aged 50 and older. It analyzes frontal X-rays of the lumbar spine, thoracic spine, chest, pelvis, knee, or hand/wrist to detect potential low BMD, prompting further clinical assessment. Licensed by Health Canada and granted FDA De Novo marketing authorization, Rho aims to enhance osteoporosis screening by leveraging existing imaging data, thereby improving early detection and treatment outcomes. The software has been implemented in various healthcare settings, including partnerships with Clear Medical Imaging and Sunnybrook Health Sciences Centre, demonstrating its effectiveness in identifying at-risk individuals and facilitating timely interventions.","categories":["diagnostic Support","clinical Care","radiology","clinical Decision Support","Diagnostic","Clinical","Radiology","Ai-driven Screening"],"market_segment":["enterprise","smb"],"target_users":["radiologists","clinicians","patients"],"specialties":["Radiology","Orthopedics","Geriatrics"],"regions_available":["Canada","United States","Australia","Singapore","Taiwan","Brazil"],"languages_supported":["English","French"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["Canada","United States"],"company_founding":"2020","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["AI-driven opportunistic screening for low bone mineral density","Utilizes routine x-rays for patient risk identification","Automated radiologist reports for at-risk patients","Integration with provider systems for personalized care plans","Increased reimbursable services for at-risk patients","Clinical risk assessment","Fall prevention","Lifestyle modification","DXA screening","Cloud or on-premise deployment options","PACS integration"],"optional_modules":["Clinical risk assessment","Fall prevention","Lifestyle modification","DXA screening"],"integrations":["PACS"],"data_standards":["FHIR","HL7 v2","DICOM"],"api_available":"unknown","system_requirements":"Major OS/DB/hardware needs, or empty if SaaS-only","compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001"],"certifications":["FDA De Novo Marketing Authorization","Health Canada License","ISO 13485"],"security_features":["Encryption","RBAC","SSO/SAML","audit logs","2FA","DLP"],"privacy_features":["BAA available","consent mgmt","anonymization","data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"2024","integration_partners":[],"id":"SW0232","slug":"rho","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/rho.json"}}