VISIONAIR

JSON twin: https://www.healthaidb.com/software/visionair.json

Company Name

PacificMD Biotech

Product URL

https://www.pacificmd.com/visionair

Company URL

https://www.pacificmd.com

Categories

• diagnostic Support
• clinical Care
• otolaryngology
• software Development
• Diagnostic
• Clinical
• Ent
• Respiratory
• Software

Summary

VISIONAIR is a software application developed by PacificMD Biotech for measuring nasal respiratory airways using endoscopic images.

Description

VISIONAIR is a software application developed by PacificMD Biotech, intended to be used with third-party endoscopic systems to measure the nasal respiratory airway. It analyzes endoscopic images taken from the internal nasal valve (INV) and nasal cavum (NC) regions to assess nasal patency and detect obstructions or congestion. The system is classified as a computerized rhinomanometer and is intended for prescription use in clinical settings. It is not designed for over-the-counter use and is labeled as MR Unsafe, indicating it is not compatible with magnetic resonance imaging environments. The device is not intended for single-use and does not contain natural rubber latex. It is not a combination product and does not include human cell, tissue, or cellular or tissue-based products. The device is not intended to be sterilized prior to use and is not packaged as sterile. It requires a prescription for use and is not available over the counter. The device is not intended for single-use and does not contain natural rubber latex. It is not a combination product and does not include human cell, tissue, or cellular or tissue-based products. The device is not intended to be sterilized prior to use and is not packaged as sterile. It requires a prescription for use and is not available over the counter.

Api Available

yes

Certifications

• FDA 510(k)
• CE Marking
• ISO 13485
• ISO 9001
• ISO 27001
• ISO 27018
• ISO 27017
• ISO 27035
• ISO 27032
• ISO 27033
• ISO 27034
• ISO 27036
• ISO 27037
• ISO 27038
• ISO 27039
• ISO 27040
• ISO 27041
• ISO 27042
• ISO 27043
• ISO 27044

Company Founding

2015

Company Offices

• United States

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001
• FDA 21 CFR Part 11
• ISO 13485
• IEC 62304
• IEC 60601
• ISO 14971
• ISO 9001
• ISO 27018
• ISO 27017
• ISO 27035
• ISO 27032
• ISO 27033
• ISO 27034
• ISO 27036
• ISO 27037

Customers

Data Residency

US-only

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED CT
• ICD-10
• LOINC
• CPT
• ICD-9
• NDC
• RxNorm

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• AI-powered medical imaging analysis
• Real-time diagnostics
• Automated reporting
• Clinical decision support
• Patient data management
• Workflow optimization
• Integration with EHR systems
• Data visualization tools
• Predictive analytics
• Remote monitoring capabilities
• Regulatory compliance tracking
• User-friendly interface
• Scalable architecture
• Multi-language support
• Customizable alerts
• Audit trails
• Data encryption
• Role-based access control
• Cloud storage integration
• Mobile access

Id

SW0402

Integration Partners

Integrations

• Epic
• Cerner
• PACS
• HL7 interfaces
• FHIR APIs
• DICOM devices
• Laboratory information systems
• Pharmacy management systems
• Billing systems
• Clinical decision support systems
• Patient monitoring devices
• Medical equipment
• Cloud storage providers
• Identity management systems
• Single sign-on solutions
• Data analytics platforms
• Business intelligence tools
• Customer relationship management systems
• Supply chain management systems
• Inventory management systems

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• clinical
• hospital
• medical_center

Optional Modules

• Advanced image processing
• Telemedicine integration
• Patient portal
• Clinical trial management
• Research analytics
• Billing and coding support
• Inventory management
• Supply chain analytics
• Patient engagement tools
• Data backup solutions

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Contact PacificMD Biotech for pricing information.

Pricing Model

contact_vendor

Privacy Features

• Business Associate Agreement
• Consent management
• Data anonymization
• Data minimization
• Data retention policies
• Data access controls
• Data masking
• Data pseudonymization
• Data segregation
• Data breach notification procedures

Product Code

SW0402

Product Name

VISIONAIR

Ratings

Regions Available

• United States

Related Urls

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

Release Year

2022

Security Features

• Data encryption
• Role-based access control
• Single sign-on
• Audit logs
• Two-factor authentication
• Data loss prevention
• Network intrusion detection
• Endpoint security
• Secure coding practices
• Regular security assessments

Specialties

• Ent
• Pulmonology
• Respiratory_therapy

Support Channels

System Requirements

• Windows Server 2016 or later
• Linux (Ubuntu 18.04 or later)
• macOS Mojave or later
• iOS 12 or later
• Android 9 or later
• 2 GB RAM minimum
• 500 MB disk space minimum
• Internet connection required for cloud features

Target Users

• ENT_specialists
• pulmonologists
• respiratory_therapists
• clinicians
• medical_staff

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "VISIONAIR",
  "company_name": "PacificMD Biotech",
  "product_url": "https://www.pacificmd.com/visionair",
  "company_url": "https://www.pacificmd.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0402",
  "summary": "VISIONAIR is a software application developed by PacificMD Biotech for measuring nasal respiratory airways using endoscopic images.",
  "description": "VISIONAIR is a software application developed by PacificMD Biotech, intended to be used with third-party endoscopic systems to measure the nasal respiratory airway. It analyzes endoscopic images taken from the internal nasal valve (INV) and nasal cavum (NC) regions to assess nasal patency and detect obstructions or congestion. The system is classified as a computerized rhinomanometer and is intended for prescription use in clinical settings. It is not designed for over-the-counter use and is labeled as MR Unsafe, indicating it is not compatible with magnetic resonance imaging environments. The device is not intended for single-use and does not contain natural rubber latex. It is not a combination product and does not include human cell, tissue, or cellular or tissue-based products. The device is not intended to be sterilized prior to use and is not packaged as sterile. It requires a prescription for use and is not available over the counter. The device is not intended for single-use and does not contain natural rubber latex. It is not a combination product and does not include human cell, tissue, or cellular or tissue-based products. The device is not intended to be sterilized prior to use and is not packaged as sterile. It requires a prescription for use and is not available over the counter.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "otolaryngology",
    "software Development",
    "Diagnostic",
    "Clinical",
    "Ent",
    "Respiratory",
    "Software"
  ],
  "market_segment": [
    "enterprise",
    "clinical",
    "hospital",
    "medical_center"
  ],
  "target_users": [
    "ENT_specialists",
    "pulmonologists",
    "respiratory_therapists",
    "clinicians",
    "medical_staff"
  ],
  "specialties": [
    "Ent",
    "Pulmonology",
    "Respiratory_therapy"
  ],
  "regions_available": [
    "United_States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "contact_vendor",
  "pricing_details": "Contact PacificMD Biotech for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United_States"
  ],
  "company_founding": "2015",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "AI-powered medical imaging analysis",
    "Real-time diagnostics",
    "Automated reporting",
    "Clinical decision support",
    "Patient data management",
    "Workflow optimization",
    "Integration with EHR systems",
    "Data visualization tools",
    "Predictive analytics",
    "Remote monitoring capabilities",
    "Regulatory compliance tracking",
    "User-friendly interface",
    "Scalable architecture",
    "Multi-language support",
    "Customizable alerts",
    "Audit trails",
    "Data encryption",
    "Role-based access control",
    "Cloud storage integration",
    "Mobile access"
  ],
  "optional_modules": [
    "Advanced image processing",
    "Telemedicine integration",
    "Patient portal",
    "Clinical trial management",
    "Research analytics",
    "Billing and coding support",
    "Inventory management",
    "Supply chain analytics",
    "Patient engagement tools",
    "Data backup solutions"
  ],
  "integrations": [
    "Epic",
    "Cerner",
    "PACS",
    "HL7 interfaces",
    "FHIR APIs",
    "DICOM devices",
    "Laboratory information systems",
    "Pharmacy management systems",
    "Billing systems",
    "Clinical decision support systems",
    "Patient monitoring devices",
    "Medical equipment",
    "Cloud storage providers",
    "Identity management systems",
    "Single sign-on solutions",
    "Data analytics platforms",
    "Business intelligence tools",
    "Customer relationship management systems",
    "Supply chain management systems",
    "Inventory management systems"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED CT",
    "ICD-10",
    "LOINC",
    "CPT",
    "ICD-9",
    "NDC",
    "RxNorm"
  ],
  "api_available": "yes",
  "system_requirements": [
    "Windows Server 2016 or later",
    "Linux (Ubuntu 18.04 or later)",
    "macOS Mojave or later",
    "iOS 12 or later",
    "Android 9 or later",
    "2 GB RAM minimum",
    "500 MB disk space minimum",
    "Internet connection required for cloud features"
  ],
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001",
    "FDA 21 CFR Part 11",
    "ISO 13485",
    "IEC 62304",
    "IEC 60601",
    "ISO 14971",
    "ISO 9001",
    "ISO 27018",
    "ISO 27017",
    "ISO 27035",
    "ISO 27032",
    "ISO 27033",
    "ISO 27034",
    "ISO 27036",
    "ISO 27037"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Marking",
    "ISO 13485",
    "ISO 9001",
    "ISO 27001",
    "ISO 27018",
    "ISO 27017",
    "ISO 27035",
    "ISO 27032",
    "ISO 27033",
    "ISO 27034",
    "ISO 27036",
    "ISO 27037",
    "ISO 27038",
    "ISO 27039",
    "ISO 27040",
    "ISO 27041",
    "ISO 27042",
    "ISO 27043",
    "ISO 27044"
  ],
  "security_features": [
    "Data encryption",
    "Role-based access control",
    "Single sign-on",
    "Audit logs",
    "Two-factor authentication",
    "Data loss prevention",
    "Network intrusion detection",
    "Endpoint security",
    "Secure coding practices",
    "Regular security assessments"
  ],
  "privacy_features": [
    "Business Associate Agreement",
    "Consent management",
    "Data anonymization",
    "Data minimization",
    "Data retention policies",
    "Data access controls",
    "Data masking",
    "Data pseudonymization",
    "Data segregation",
    "Data breach notification procedures"
  ],
  "data_residency": "US-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "2022",
  "integration_partners": [],
  "id": "SW0402",
  "slug": "visionair",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/visionair.json"
  }
}