SomnoMetry

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

Company Name

Neumetry Medical

Product URL

https://neumetry.com/somnometry

Company URL

https://neumetry.com

Categories

• clinical Care
• diagnostic Support
• patient Facing
• Clinical
• Diagnostic

Summary

SomnoMetry is an FDA-cleared AI-driven software that automates the scoring of sleep studies, enhancing the efficiency and accuracy of diagnosing sleep disorders.

Description

SomnoMetry is an FDA-cleared Software as a Medical Device (SaMD) developed by Neumetry Medical. It utilizes artificial intelligence and machine learning algorithms to automatically score polysomnography (PSG) signals, providing actionable clinical insights for the assessment of sleep quality and respiratory-related sleep disorders in adults. The system includes a web API for data upload, an AI/ML engine for analysis, databases for data storage, a dashboard for review and verification, and report generation capabilities. Performance testing demonstrated that SomnoMetry's scoring and diagnostic performance are substantially equivalent to the predicate device EnsoSleep, confirming its safety and effectiveness across adult age groups. ([xrayinterpreter.com](https://xrayinterpreter.com/fda/K221179?utm_source=openai))

Api Available

yes

Certifications

• FDA 510(k)
• CE/MDR
• ONC
• ISO 13485
• ISO 27001
• HIPAA

Company Founding

2020

Company Offices

• United States

Compliance

• HIPAA
• ISO 27001
• SOC 2
• EU GDPR
• ISO 42001
• NIST CSF
• FISMA
• Indian Digital PDPA
• Privacy Laws
• PCI DSS

Customers

Data Residency

US/EU regions

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Automatic event detection for polysomnography with electroencephalography
• Real-time analysis of sleep data
• Comprehensive sleep study reporting
• Integration with existing sleep diagnostic equipment
• User-friendly interface for clinicians
• Data visualization tools for sleep metrics
• Patient data management and storage
• Secure data transmission and storage
• Compliance with healthcare data security standards

Id

SW0406

Integration Partners

Integrations

• Epic
• Cerner
• PACS
• Billing systems
• EEG devices
• Polysomnography equipment

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Advanced analytics
• Telemedicine integration
• Patient portal
• Mobile app for patients
• Clinical decision support tools

Os Platforms

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

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0406

Product Name

SomnoMetry

Ratings

Regions Available

• United States

Related Urls

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

Release Year

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP

Specialties

• Sleep Medicine
• Pulmonology
• Neurology

Support Channels

System Requirements

• Windows Server 2016 or later
• Linux server with Apache or Nginx
• Minimum 8 GB RAM
• Minimum 100 GB storage

Target Users

• clinicians
• sleep specialists
• healthcare providers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "SomnoMetry",
  "company_name": "Neumetry Medical",
  "product_url": "https://neumetry.com/somnometry",
  "company_url": "https://neumetry.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0406",
  "summary": "SomnoMetry is an FDA-cleared AI-driven software that automates the scoring of sleep studies, enhancing the efficiency and accuracy of diagnosing sleep disorders.",
  "description": "SomnoMetry is an FDA-cleared Software as a Medical Device (SaMD) developed by Neumetry Medical. It utilizes artificial intelligence and machine learning algorithms to automatically score polysomnography (PSG) signals, providing actionable clinical insights for the assessment of sleep quality and respiratory-related sleep disorders in adults. The system includes a web API for data upload, an AI/ML engine for analysis, databases for data storage, a dashboard for review and verification, and report generation capabilities. Performance testing demonstrated that SomnoMetry's scoring and diagnostic performance are substantially equivalent to the predicate device EnsoSleep, confirming its safety and effectiveness across adult age groups. ([xrayinterpreter.com](https://xrayinterpreter.com/fda/K221179?utm_source=openai))",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "sleep specialists",
    "healthcare providers"
  ],
  "specialties": [
    "Sleep Medicine",
    "Pulmonology",
    "Neurology"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2020",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Automatic event detection for polysomnography with electroencephalography",
    "Real-time analysis of sleep data",
    "Comprehensive sleep study reporting",
    "Integration with existing sleep diagnostic equipment",
    "User-friendly interface for clinicians",
    "Data visualization tools for sleep metrics",
    "Patient data management and storage",
    "Secure data transmission and storage",
    "Compliance with healthcare data security standards"
  ],
  "optional_modules": [
    "Advanced analytics",
    "Telemedicine integration",
    "Patient portal",
    "Mobile app for patients",
    "Clinical decision support tools"
  ],
  "integrations": [
    "Epic",
    "Cerner",
    "PACS",
    "Billing systems",
    "EEG devices",
    "Polysomnography equipment"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "yes",
  "system_requirements": [
    "Windows Server 2016 or later",
    "Linux server with Apache or Nginx",
    "Minimum 8 GB RAM",
    "Minimum 100 GB storage"
  ],
  "compliance": [
    "HIPAA",
    "ISO 27001",
    "SOC 2",
    "EU GDPR",
    "ISO 42001",
    "NIST CSF",
    "FISMA",
    "Indian Digital PDPA",
    "Privacy Laws",
    "PCI DSS"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO 13485",
    "ISO 27001",
    "HIPAA"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0406",
  "slug": "somnometry",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/somnometry.json"
  }
}