Dreem 3S
JSON twin: https://www.healthaidb.com/software/dreem-3s.json
Company Name
Beacon Biosignals
Product URL
https://www.beaconbiosignals.com/dreem-3s
Company URL
https://www.beaconbiosignals.com
Categories
Summary
Waveband, formerly Dreem 3S, is a wearable EEG headband by Beacon Biosignals that enables at-home, clinically validated sleep monitoring, aiding in the diagnosis of sleep disorders.
Description
Waveband is a wearable EEG headband developed by Beacon Biosignals, designed for at-home sleep monitoring. It captures clinical-grade EEG data to assess sleep architecture, providing a validated alternative to in-lab polysomnography. The device features six dry-EEG electrodes and an accelerometer for head movement and body position monitoring. Its AI-driven sleep staging algorithm has been validated to perform as well or better than human experts. In December 2024, the FDA authorized a Predetermined Change Control Plan (PCCP) for Waveband, allowing continuous algorithm enhancements without requiring new 510(k) submissions. This capability supports ongoing improvements in sleep monitoring and therapy development for neurological and psychiatric disorders. The device is marketed under the name Waveband as of June 2025, maintaining its FDA 510(k) clearance status. ([beacon.bio](https://beacon.bio/news/fda-authorizes-beacon-s-dreem-3s-as-first-sleep-wearable-with-predetermined-change-control-plan-paving-the-way-for-continuous-algorithm-enhancements-in-sleep-monitoring?utm_source=openai))
Api Available
unknown
Certifications
- FDA 510(k) clearance
- PCCP authorization
Company Founding
2018
Company Offices
Compliance
- FDA 510(k) clearance
- Predetermined Change Control Plan (PCCP)
Customers
Data Residency
US/EU regions
Data Standards
- EEG data
- Sleep staging data
Deployment Model
Features
- Clinical-grade EEG data collection
- Automated sleep staging
- In-home sleep monitoring
- Patient-initiated recordings
- Customizable self-report questionnaires
- Multi-language support
- Longitudinal monitoring
- High patient usability
- Validated alternative to in-lab polysomnography
Id
SW0124
Integration Partners
Integrations
Languages Supported
- English
- French
- German
- Spanish
- Italian
- Dutch
- Swedish
- Norwegian
- Danish
- Portuguese
- Russian
- Chinese
- Japanese
- Korean
- Hindi
- Arabic
- Turkish
- Polish
- Czech
- Hungarian
Last Updated
2025-10-11
License
Commercial
Market Segment
Optional Modules
Os Platforms
Pricing Details
Contact vendor for pricing information.
Pricing Model
Subscription
Privacy Features
- Patient-initiated recordings
- Customizable self-report questionnaires
Product Code
SW0124
Product Name
Dreem 3S
Ratings
Regions Available
Related Urls
Release Year
Security Features
- Secure, encrypted wireless connection
- Version-controlled deployment
Specialties
Support Channels
System Requirements
iOS 12.0 or later, Android 6.0 or later
Target Users
- Clinicians
- Patients
- Researchers
Training Options
Type
product
User Reviews
Version
1.0
Alternatives
See related products
Canonical JSON
{
"product_name": "Dreem 3S",
"company_name": "Beacon Biosignals",
"product_url": "https://www.beaconbiosignals.com/dreem-3s",
"company_url": "https://www.beaconbiosignals.com",
"related_urls": [
"https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
],
"product_code": "SW0124",
"summary": "Waveband, formerly Dreem 3S, is a wearable EEG headband by Beacon Biosignals that enables at-home, clinically validated sleep monitoring, aiding in the diagnosis of sleep disorders.",
"description": "Waveband is a wearable EEG headband developed by Beacon Biosignals, designed for at-home sleep monitoring. It captures clinical-grade EEG data to assess sleep architecture, providing a validated alternative to in-lab polysomnography. The device features six dry-EEG electrodes and an accelerometer for head movement and body position monitoring. Its AI-driven sleep staging algorithm has been validated to perform as well or better than human experts. In December 2024, the FDA authorized a Predetermined Change Control Plan (PCCP) for Waveband, allowing continuous algorithm enhancements without requiring new 510(k) submissions. This capability supports ongoing improvements in sleep monitoring and therapy development for neurological and psychiatric disorders. The device is marketed under the name Waveband as of June 2025, maintaining its FDA 510(k) clearance status. ([beacon.bio](https://beacon.bio/news/fda-authorizes-beacon-s-dreem-3s-as-first-sleep-wearable-with-predetermined-change-control-plan-paving-the-way-for-continuous-algorithm-enhancements-in-sleep-monitoring?utm_source=openai))",
"categories": [
"clinical Care",
"diagnostic Support",
"patient Facing",
"Clinical",
"Diagnostic",
"Patient-facing"
],
"market_segment": [
"Enterprise",
"SMB",
"Consumer"
],
"target_users": [
"Clinicians",
"Patients",
"Researchers"
],
"specialties": [
"Neurology",
"Psychiatry",
"Sleep Medicine"
],
"regions_available": [
"United States",
"Europe",
"Canada",
"Australia",
"Japan",
"South Korea",
"China",
"India",
"Brazil",
"Mexico",
"South Africa",
"Russia",
"United Kingdom",
"Germany",
"France",
"Italy",
"Spain",
"Netherlands",
"Sweden",
"Norway",
"Denmark"
],
"languages_supported": [
"English",
"French",
"German",
"Spanish",
"Italian",
"Dutch",
"Swedish",
"Norwegian",
"Danish",
"Portuguese",
"Russian",
"Chinese",
"Japanese",
"Korean",
"Hindi",
"Arabic",
"Turkish",
"Polish",
"Czech",
"Hungarian"
],
"pricing_model": "Subscription",
"pricing_details": "Contact vendor for pricing information.",
"license": "Commercial",
"company_offices": [
"United States",
"France",
"United Kingdom",
"Germany",
"Canada",
"Australia",
"Japan",
"South Korea",
"China",
"India"
],
"company_founding": "2018",
"deployment_model": [
"SaaS",
"on_prem",
"hybrid"
],
"os_platforms": [
"Web",
"iOS",
"Android"
],
"features": [
"Clinical-grade EEG data collection",
"Automated sleep staging",
"In-home sleep monitoring",
"Patient-initiated recordings",
"Customizable self-report questionnaires",
"Multi-language support",
"Longitudinal monitoring",
"High patient usability",
"Validated alternative to in-lab polysomnography"
],
"optional_modules": [
"Beacon Pal app"
],
"integrations": [
"Beacon Pal app"
],
"data_standards": [
"EEG data",
"Sleep staging data"
],
"api_available": "unknown",
"system_requirements": "iOS 12.0 or later, Android 6.0 or later",
"compliance": [
"FDA 510(k) clearance",
"Predetermined Change Control Plan (PCCP)"
],
"certifications": [
"FDA 510(k) clearance",
"PCCP authorization"
],
"security_features": [
"Secure, encrypted wireless connection",
"Version-controlled deployment"
],
"privacy_features": [
"Patient-initiated recordings",
"Customizable self-report questionnaires"
],
"data_residency": "US/EU regions",
"customers": [],
"user_reviews": [],
"ratings": [],
"support_channels": [],
"training_options": [],
"release_year": "",
"integration_partners": [],
"id": "SW0124",
"slug": "dreem-3s",
"type": "product",
"version": "1.0",
"last_updated": "2025-10-11",
"links_json": {
"self": "https://www.healthaidb.com/software/dreem-3s.json"
}
}