Vivio LVEDP System

JSON twin: https://www.healthaidb.com/software/vivio-lvedp-system.json

Company Name

Avicena

Product URL

https://www.avicena.com

Company URL

https://www.avicena.com

Categories

• diagnostic Support
• clinical Care
• administrative Operations
• patient Facing
• Diagnostic
• Clinical
• Administrative

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.

Api Available

yes

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

Company Founding

2019

Company Offices

• Australia
• United Kingdom
• United States
• United Arab Emirates
• Saudi Arabia
• Qatar
• Kuwait
• Bahrain
• Oman
• Jordan

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

Customers

Data Residency

US-based data centers

Data Standards

• HL7
• FHIR
• DICOM
• ICD-10
• SNOMED CT
• LOINC
• CPT
• ICD-9
• NDC
• HCPCS

Deployment Model

• on_prem

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

Id

SW0302

Integration Partners

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

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb
• consumer

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

Os Platforms

• Windows
• Linux

Pricing Details

contact vendor

Pricing Model

subscription

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

Product Code

SW0302

Product Name

Vivio LVEDP System

Ratings

Regions Available

• Australia
• United Kingdom
• United States
• Middle East

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

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

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

Support Channels

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

Target Users

• clinicians
• nurses
• patients
• admins
• payers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "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": [
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  "market_segment": [
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  "target_users": [
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    "nurses",
    "patients",
    "admins",
    "payers"
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  "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"
  }
}