Genio

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

Company Name

Nyxoah

Product URL

https://www.nyxoah.com/en/genio

Company URL

https://www.nyxoah.com

Categories

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

Summary

Genio is a battery-free, leadless neurostimulator developed by Nyxoah to treat moderate to severe Obstructive Sleep Apnea (OSA) through bilateral hypoglossal nerve stimulation, offering an alternative to CPAP therapy.

Description

Genio is a medical device designed to treat moderate to severe Obstructive Sleep Apnea (OSA) by stimulating the hypoglossal nerve bilaterally, keeping the upper airway open during sleep. It features a battery-free, leadless neurostimulator implanted via a single incision and is powered by an external wearable component. The system is MRI-compatible at 1.5T and 3T, and the wearable component is upgradable without additional surgeries. Genio has received FDA approval for patients with an Apnea-Hypopnea Index (AHI) between 15 and 65 who cannot tolerate, have failed, or refused CPAP therapy. It is also CE-marked in Europe for both Complete Concentric Collapse (CCC) and non-CCC patients. The device is available in the United States and the Middle East, with ongoing commercialization efforts in these regions.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• CE mark
• ISO 13485
• ISO 14971
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15

Company Founding

2009

Company Offices

• Belgium
• United States
• United Arab Emirates
• France
• Germany
• United Kingdom
• Italy
• Spain
• Netherlands
• Switzerland

Compliance

• FDA 510(k) clearance
• CE mark
• ISO 13485
• ISO 14971
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15

Customers

Data Residency

Data stored in UK data centers

Data Standards

• FDA 510(k) clearance
• CE mark
• ISO 13485
• ISO 14971
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Battery-free stimulator
• External power unit
• Bilateral nerve stimulation
• MRI compatibility (1.5T and 3T)
• Single incision procedure
• Patient-centric smartphone app
• Mask-free therapy
• Upgradable technology without added procedures
• High patient satisfaction rates
• Significant reduction in sleep-related breathing events

Id

SW2781

Integration Partners

Integrations

• Smartphone app
• Sleep wearable
• Activation chip
• Portable charger

Languages Supported

• English
• Arabic
• French

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• Sleep wearable
• Activation chip
• Portable charger

Os Platforms

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

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• Business Associate Agreement (BAA)
• Consent management
• Anonymization
• Data minimization

Product Code

SW2781

Product Name

Genio

Ratings

Regions Available

• United States
• Middle East
• Europe

Related Urls

Release Year

Security Features

• Data encryption
• Role-based access control (RBAC)
• Audit logs
• Two-factor authentication (2FA)
• Data loss prevention (DLP)

Specialties

• Sleep Medicine
• Pulmonology
• Neurology

Support Channels

System Requirements

Compatible with 1.5T and 3T MRI scanners

Target Users

• patients
• clinicians
• admins

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Genio",
  "company_name": "Nyxoah",
  "product_url": "https://www.nyxoah.com/en/genio",
  "company_url": "https://www.nyxoah.com",
  "related_urls": [],
  "product_code": "SW2781",
  "summary": "Genio is a battery-free, leadless neurostimulator developed by Nyxoah to treat moderate to severe Obstructive Sleep Apnea (OSA) through bilateral hypoglossal nerve stimulation, offering an alternative to CPAP therapy.",
  "description": "Genio is a medical device designed to treat moderate to severe Obstructive Sleep Apnea (OSA) by stimulating the hypoglossal nerve bilaterally, keeping the upper airway open during sleep. It features a battery-free, leadless neurostimulator implanted via a single incision and is powered by an external wearable component. The system is MRI-compatible at 1.5T and 3T, and the wearable component is upgradable without additional surgeries. Genio has received FDA approval for patients with an Apnea-Hypopnea Index (AHI) between 15 and 65 who cannot tolerate, have failed, or refused CPAP therapy. It is also CE-marked in Europe for both Complete Concentric Collapse (CCC) and non-CCC patients. The device is available in the United States and the Middle East, with ongoing commercialization efforts in these regions.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "patients",
    "clinicians",
    "admins"
  ],
  "specialties": [
    "Sleep Medicine",
    "Pulmonology",
    "Neurology"
  ],
  "regions_available": [
    "United States",
    "Middle East",
    "Europe"
  ],
  "languages_supported": [
    "English",
    "Arabic",
    "French"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "Belgium",
    "United States",
    "United Arab Emirates",
    "France",
    "Germany",
    "United Kingdom",
    "Italy",
    "Spain",
    "Netherlands",
    "Switzerland"
  ],
  "company_founding": "2009",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Battery-free stimulator",
    "External power unit",
    "Bilateral nerve stimulation",
    "MRI compatibility (1.5T and 3T)",
    "Single incision procedure",
    "Patient-centric smartphone app",
    "Mask-free therapy",
    "Upgradable technology without added procedures",
    "High patient satisfaction rates",
    "Significant reduction in sleep-related breathing events"
  ],
  "optional_modules": [
    "Sleep wearable",
    "Activation chip",
    "Portable charger"
  ],
  "integrations": [
    "Smartphone app",
    "Sleep wearable",
    "Activation chip",
    "Portable charger"
  ],
  "data_standards": [
    "FDA 510(k) clearance",
    "CE mark",
    "ISO 13485",
    "ISO 14971",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15"
  ],
  "api_available": "unknown",
  "system_requirements": "Compatible with 1.5T and 3T MRI scanners",
  "compliance": [
    "FDA 510(k) clearance",
    "CE mark",
    "ISO 13485",
    "ISO 14971",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE mark",
    "ISO 13485",
    "ISO 14971",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15"
  ],
  "security_features": [
    "Data encryption",
    "Role-based access control (RBAC)",
    "Audit logs",
    "Two-factor authentication (2FA)",
    "Data loss prevention (DLP)"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA)",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "Data stored in UK data centers",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW2781",
  "slug": "genio",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/genio.json"
  }
}