{"product_name":"Vivio LVEDP System","company_name":"Avicena","product_url":"https://www.avicena.com","company_url":"https://www.avicena.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0302","summary":"Avicena is an Australian medical technology company specializing in rapid, scalable pathogen detection systems for human and animal health, utilizing advanced molecular diagnostics to safeguard communities and economies from disease outbreaks.","description":"Avicena develops the Sentinel platform, an ultra-scalable rapid molecular diagnostic system built on LAMP technology, capable of processing up to 100,000 samples per day with results in under 30 minutes. The company offers two main instruments: Sentinel ULTRA for large-scale screening and Sentinel Mini for on-site diagnostics. Avicena is ISO 13485 certified and CE-Marked for in-vitro diagnostic use, with a focus on human and animal health applications. The company is headquartered in Perth, Australia, with expansions into the UK, US, and Middle East, partnering with governments, health providers, and industry to deliver scalable diagnostics through flexible business models including sales, rentals, and long-term service contracts.","categories":["diagnostic Support","clinical Care","administrative Operations","patient Facing","Diagnostic","Clinical","Administrative","Patient-facing"],"market_segment":["enterprise","smb","consumer"],"target_users":["clinicians","nurses","patients","admins","payers"],"specialties":["Infectious Diseases","Pandemic Surveillance","Biosecurity","Molecular Diagnostics","Pathogen Detection","Public Health","Animal Health","Food Safety","Environmental Health","Veterinary Medicine","Epidemiology","Biotechnology","Medical Technology","Healthcare","Laboratory Diagnostics","Health Informatics","Clinical Research","Health Policy","Global Health","Health Systems","Health Economics"],"regions_available":["Australia","United Kingdom","United States","Middle East"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["Australia","United Kingdom","United States","United Arab Emirates","Saudi Arabia","Qatar","Kuwait","Bahrain","Oman","Jordan"],"company_founding":"2019","deployment_model":["on_prem"],"os_platforms":["Windows","Linux"],"features":["Non-invasive estimation of left ventricular end-diastolic pressure (LVEDP)","FDA 510(k) clearance (K223905)","Clinical validation study with 728 individuals across 7 U.S. medical centers","Sensitivity of 0.84 and specificity of 0.84 in cross-validation analysis","Indicated for adults to estimate if LVEDP is above or below 18 mm Hg","Utilizes advanced sensor technology for accurate measurements","Portable and user-friendly design for outpatient settings","Real-time data processing and display","Wireless data transmission capabilities","Integration with electronic health records (EHR) systems","Battery-operated with long-lasting power for extended use","Compact and lightweight for easy handling","Durable construction suitable for clinical environments","Low maintenance requirements","Comprehensive user manual and training materials provided","Remote software update capability","Data storage with secure backup options","Compliance with medical device regulations","User authentication and access control features","Audible and visual alerts for measurement errors or device issues"],"optional_modules":["Advanced data analytics module","Cloud-based data storage and management","Integration with telemedicine platforms","Patient monitoring dashboard","Automated reporting and documentation","Integration with laboratory information systems (LIS)","Customizable measurement protocols","Multi-device synchronization","Patient demographic management","Integration with wearable health devices"],"integrations":["EHR systems","Telemedicine platforms","LIS","Wearable health devices","Cloud-based data storage","Patient monitoring dashboard","Laboratory information systems","Customizable measurement protocols","Multi-device synchronization","Patient demographic management"],"data_standards":["HL7","FHIR","DICOM","ICD-10","SNOMED CT","LOINC","CPT","ICD-9","NDC","HCPCS"],"api_available":"yes","system_requirements":["Windows 10 or later","Linux kernel 4.4 or later","2 GB RAM","500 MB free disk space","USB port for device connection","Wi-Fi or Ethernet connection for data transmission","Bluetooth 4.0 or later for wireless communication","HDMI port for external display (optional)","Power supply: 100-240V AC, 50/60Hz","Operating temperature: 10°C to 40°C"],"compliance":["HIPAA","FDA 510(k)","ISO 13485","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-15","IEC 60601-1-16"],"certifications":["FDA 510(k) clearance (K223905)","CE Marking","ISO 13485:2016","ISO 14971:2019","IEC 60601-1:2012","IEC 60601-1-2:2014","IEC 60601-1-6:2010","IEC 60601-1-11:2015","IEC 60601-1-12:2014","IEC 60601-1-15:2017"],"security_features":["Data encryption at rest and in transit","Role-based access control (RBAC)","Single sign-on (SSO)","Audit logs","Two-factor authentication (2FA)","Secure software development lifecycle (SDLC)","Regular security vulnerability assessments","Compliance with security standards (e.g., ISO 27001)","Data anonymization techniques","Secure data storage and backup"],"privacy_features":["Data anonymization","Data minimization","User consent management","Data access controls","Data retention policies","Compliance with data protection regulations (e.g., GDPR)","Regular privacy impact assessments","User data rights management","Secure data sharing protocols","Privacy training for staff"],"data_residency":"US-based data centers","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0302","slug":"vivio-lvedp-system","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/vivio-lvedp-system.json"}}