{"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"}}