SleepStageML

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

Company Name

Beacon Biosignals

Product URL

https://beaconbiosignals.com

Company URL

https://beaconbiosignals.com

Categories

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

Summary

SleepStageML is an FDA-cleared machine learning software by Beacon Biosignals that automates sleep staging from EEG signals in polysomnography recordings, enhancing the diagnosis and evaluation of sleep disorders.

Description

SleepStageML utilizes advanced deep-learning algorithms to automatically score sleep stages from EEG signals in clinical polysomnography recordings. Trained on a vast dataset of hundreds of thousands of hours of PSG recordings from both healthy individuals and patients with various sleep disorders, neurologic, and psychiatric diseases, it aims to improve the consistency, efficiency, and precision of sleep staging. The software is FDA-cleared with a Predetermined Change Control Plan, allowing continuous improvements to its machine-learning algorithm within the scope of its initial clearance. This capability enables Beacon Biosignals to iteratively refine SleepStageML's algorithms over time while ensuring safety and efficacy standards are met. The software complements Beacon's Dreem 3S wearable headband, providing a comprehensive solution for measuring sleep architecture across home and clinical settings. Key benefits include automating the manual sleep staging process, reducing subjective variability in scoring, and supporting faster PSG analysis turnaround times. Clinical validation testing demonstrated that SleepStageML performs as well or better than individual human experts, as reported in literature. This advancement positions Beacon Biosignals as a premier technology partner for pharmaceutical companies, research institutions, and clinical trial organizations seeking to incorporate high-fidelity brain monitoring and sleep measurement into their neuroscience, psychiatry, sleep, and neurodegenerative disease research programs.

Api Available

unknown

Certifications

• FDA 510(k) clearance for SleepStageML
• FDA 510(k) clearance for Dreem 3S headband

Company Founding

2018

Company Offices

• United States
• United Kingdom
• Germany
• France
• Canada
• Australia
• Japan
• South Korea
• China
• India

Compliance

• FDA 510(k) clearance
• Predetermined Change Control Plan (PCCP)

Customers

Data Residency

US and EU regions

Data Standards

• EEG
• Polysomnography (PSG)

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Automated sleep staging from EEG signals
• Advanced deep-learning model for sleep scoring
• Clinical-grade sleep analysis
• Integration with Dreem 3S EEG headband
• FDA 510(k) clearance for SleepStageML
• FDA 510(k) clearance for Dreem 3S headband
• Predetermined Change Control Plan (PCCP) for continuous algorithm improvement

Id

SW0245

Integration Partners

Integrations

• Dreem 3S EEG headband
• Beacon Datastore
• Beacon HQ
• Beacon Pal app

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Bengali
• Punjabi
• Telugu
• Marathi
• Tamil
• Urdu
• Gujarati

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Clinical Study Operations
• Scientific Services
• Beacon Datastore
• Beacon HQ
• Waveband
• Beacon Pal app

Os Platforms

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

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• Data anonymization
• Consent management
• Data minimization
• Compliance with GDPR
• Automated cross-region backups
• GCP-compliant retention policies

Product Code

SW0245

Product Name

SleepStageML

Ratings

Regions Available

• United States
• Europe
• Canada
• Australia
• Japan
• South Korea
• China
• India
• Brazil
• Mexico
• South Africa
• Russia
• Saudi Arabia
• United Arab Emirates
• Singapore
• Malaysia
• Thailand
• Indonesia
• Philippines
• Vietnam

Related Urls

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

Release Year

Security Features

• Data encryption
• Access controls
• Audit logs
• Data anonymization
• Compliance with SOC 2 Type 2
• GDPR compliance
• Automated cross-region backups
• GCP-compliant retention policies

Specialties

• Sleep Medicine
• Neurology
• Psychiatry
• Neurodegenerative Diseases
• Epilepsy
• Alzheimer's Disease
• Schizophrenia
• Major Depressive Disorder
• Narcolepsy
• Lennox-gastaut Syndrome

Support Channels

System Requirements

High-performance computing resources for AI/ML processing

Target Users

• Clinicians
• Researchers
• Sleep Technologists
• Healthcare Providers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "SleepStageML",
  "company_name": "Beacon Biosignals",
  "product_url": "https://beaconbiosignals.com",
  "company_url": "https://beaconbiosignals.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0245",
  "summary": "SleepStageML is an FDA-cleared machine learning software by Beacon Biosignals that automates sleep staging from EEG signals in polysomnography recordings, enhancing the diagnosis and evaluation of sleep disorders.",
  "description": "SleepStageML utilizes advanced deep-learning algorithms to automatically score sleep stages from EEG signals in clinical polysomnography recordings. Trained on a vast dataset of hundreds of thousands of hours of PSG recordings from both healthy individuals and patients with various sleep disorders, neurologic, and psychiatric diseases, it aims to improve the consistency, efficiency, and precision of sleep staging. The software is FDA-cleared with a Predetermined Change Control Plan, allowing continuous improvements to its machine-learning algorithm within the scope of its initial clearance. This capability enables Beacon Biosignals to iteratively refine SleepStageML's algorithms over time while ensuring safety and efficacy standards are met. The software complements Beacon's Dreem 3S wearable headband, providing a comprehensive solution for measuring sleep architecture across home and clinical settings. Key benefits include automating the manual sleep staging process, reducing subjective variability in scoring, and supporting faster PSG analysis turnaround times. Clinical validation testing demonstrated that SleepStageML performs as well or better than individual human experts, as reported in literature. This advancement positions Beacon Biosignals as a premier technology partner for pharmaceutical companies, research institutions, and clinical trial organizations seeking to incorporate high-fidelity brain monitoring and sleep measurement into their neuroscience, psychiatry, sleep, and neurodegenerative disease research programs.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "administrative Operations",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Administrative",
    "Patient-facing"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Researchers",
    "Sleep Technologists",
    "Healthcare Providers"
  ],
  "specialties": [
    "Sleep Medicine",
    "Neurology",
    "Psychiatry",
    "Neurodegenerative Diseases",
    "Epilepsy",
    "Alzheimer's Disease",
    "Schizophrenia",
    "Major Depressive Disorder",
    "Narcolepsy",
    "Lennox-gastaut Syndrome"
  ],
  "regions_available": [
    "United States",
    "Europe",
    "Canada",
    "Australia",
    "Japan",
    "South Korea",
    "China",
    "India",
    "Brazil",
    "Mexico",
    "South Africa",
    "Russia",
    "Saudi Arabia",
    "United Arab Emirates",
    "Singapore",
    "Malaysia",
    "Thailand",
    "Indonesia",
    "Philippines",
    "Vietnam"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Telugu",
    "Marathi",
    "Tamil",
    "Urdu",
    "Gujarati"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "United Kingdom",
    "Germany",
    "France",
    "Canada",
    "Australia",
    "Japan",
    "South Korea",
    "China",
    "India"
  ],
  "company_founding": "2018",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Automated sleep staging from EEG signals",
    "Advanced deep-learning model for sleep scoring",
    "Clinical-grade sleep analysis",
    "Integration with Dreem 3S EEG headband",
    "FDA 510(k) clearance for SleepStageML",
    "FDA 510(k) clearance for Dreem 3S headband",
    "Predetermined Change Control Plan (PCCP) for continuous algorithm improvement"
  ],
  "optional_modules": [
    "Clinical Study Operations",
    "Scientific Services",
    "Beacon Datastore",
    "Beacon HQ",
    "Waveband",
    "Beacon Pal app"
  ],
  "integrations": [
    "Dreem 3S EEG headband",
    "Beacon Datastore",
    "Beacon HQ",
    "Beacon Pal app"
  ],
  "data_standards": [
    "EEG",
    "Polysomnography (PSG)"
  ],
  "api_available": "unknown",
  "system_requirements": "High-performance computing resources for AI/ML processing",
  "compliance": [
    "FDA 510(k) clearance",
    "Predetermined Change Control Plan (PCCP)"
  ],
  "certifications": [
    "FDA 510(k) clearance for SleepStageML",
    "FDA 510(k) clearance for Dreem 3S headband"
  ],
  "security_features": [
    "Data encryption",
    "Access controls",
    "Audit logs",
    "Data anonymization",
    "Compliance with SOC 2 Type 2",
    "GDPR compliance",
    "Automated cross-region backups",
    "GCP-compliant retention policies"
  ],
  "privacy_features": [
    "Data anonymization",
    "Consent management",
    "Data minimization",
    "Compliance with GDPR",
    "Automated cross-region backups",
    "GCP-compliant retention policies"
  ],
  "data_residency": "US and EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0245",
  "slug": "sleepstageml",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/sleepstageml.json"
  }
}