What Beacon Biosignals does

Beacon Biosignals, founded in 2019 and headquartered in Boston, operates an end-to-end precision neuroscience platform that combines an FDA 510(k)-cleared at-home EEG headband (Waveband, formerly Dreem 3S) with a cloud-native data layer (Beacon Datastore), an analytics and trial management portal (Beacon HQ), AI/ML sleep staging (SleepStage ML), a Bluetooth-paired patient companion app (Beacon Pal), and full-service clinical study operations and scientific services teams. The platform is the first sleep wearable authorized under an FDA Predetermined Change Control Plan (PCCP), enabling continuous algorithm updates without new 510(k) submissions, and is supported by a proprietary foundation model of brain activity trained on millions of hours of EEG across a Clinico-EEG database containing data from nearly 100,000 patients. Beacon serves two distinct customer segments: (1) biopharmaceutical R&D teams — including Takeda, Harmony Biosciences, UCB, Longboard Pharmaceuticals, Skye Bioscience, and Syndeio, with the company claiming R&D program support for more than half of the world's top ten biopharma — who pay under multi-year enterprise data licensing and milestone structures (e.g., up to $109M in potential Takeda data license fees and milestones), and (2) sleep physicians, neurologists, and primary care providers, served through the SleepView Monitor, SleepView Direct mail-order fulfillment, and SleepView Web Portal acquired from CleveMed in April 2025 and rebranded under Beacon in June 2026. Revenue mechanics span enterprise subscription/analytics access, bundled HST per-study plans (Gold and Silver), device hardware sales, and milestone-based licensing with strategic biopharma partners.

Name

Beacon Biosignals

Legal name

Beacon Biosignals, Inc.

Website

https://beacon.bio

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

101–250 employees

Short description

Beacon Biosignals operates an AI-powered precision neuroscience platform combining an FDA-cleared at-home EEG headband with cloud analytics, serving biopharmaceutical sponsors running CNS clinical trials and healthcare providers delivering home sleep testing.

Ownership category

akta.pro rank

Product category

Neurotechnology & Brain Health Analytics

NAICS

Medical and Diagnostic Laboratories (6215), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

akta.pro secondary industries

Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Cell-Based & Potency Assays (Bioassays) (HLAGADAH), Connected Therapeutics & Smart Drug Delivery Monitoring (HLACAFAL), SaMD – Digital Biomarkers & Algorithmic Endpoints (HLACANAF)

Keywords

• EEG analytics platform
• At-home sleep monitoring
• CNS clinical trials
• Home sleep testing
• Brain health biomarkers

Headquarters

HQ city

Boston

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. SleepView Direct bundled study pricing: Mail-order home sleep testing offered under Gold and Silver bundled per-study plans that include the SleepView Monitor, Web Portal access, shipping/handling, disposable accessories, patient phone support, and (Gold) RPSGT manual scoring. Sold primarily to sleep centers and providers.
2. SleepView Monitor hardware + SleepView Web Portal subscription: Sale or deployment of the SleepView Monitor device plus recurring access to the HIPAA-compliant SleepView Web Portal (file management, automated respiratory event scoring, EMR integrations, complimentary upgrades and support). Optional CPAP connector, thermistor, second effort belt, and ID Check accessories.
3. Biopharma data licensing and milestone payments (Takeda model): Multi-year data-license agreements with development, regulatory, and commercial milestones plus equity participation. Example: expanded Takeda collaboration in which Beacon is eligible to receive up to $109 million in data license fees and milestones. Effectively a licensing/royalty-plus-milestone revenue stream from CNS drug developers.
4. Clinical Study Operations and Scientific Services (professional services): Full-service clinical trial support including device deployment/logistics, low-latency compliance monitoring, site and user training, integrated data solutions, scientific endpoint advice, biostatistics and signal-processing analyses, and translational medicine / biomarker discovery. Typically bundled with biopharma EEG biomarker programs.
5. Beacon Platform enterprise analytics (Datastore + Beacon HQ): Enterprise access to the Beacon Datastore and Beacon HQ analytics portal — centralized EEG data storage, AI-powered analytics, dataset drill-downs, regulatory dataset downloads, and event monitoring — typically delivered under enterprise agreements with biopharma sponsors.

Pricing tiers

Go-to-market motion5 records

Distribution channels4 records

Marketing channels9 records

Core offering

Beacon Biosignals provides an end-to-end precision neuroscience platform that combines an FDA 510(k)-cleared at-home EEG headband (Waveband, formerly Dreem 3S) with a cloud-native AI/ML analytics stack (Beacon Datastore, Beacon HQ, SleepStage ML) and proprietary brain-activity foundation models to deliver EEG biomarkers, quantitative endpoints, and sleep diagnostics for CNS drug development and clinical care. The platform supports Phase 1-4 clinical trials for biopharmaceutical sponsors and is paired with a home sleep testing business (SleepView Monitor, SleepView Direct, SleepView Web Portal) acquired from CleveMed that serves sleep physicians, neurologists, and primary care providers.

Product overview

Beacon Biosignals operates an end-to-end precision neuroscience platform that combines an FDA 510(k)-cleared wearable EEG device (Waveband, formerly Dreem 3S) with an AI-driven analytics stack to capture and analyze sleep brain data at home for both clinical trials and clinical care. The platform is built around the Beacon Datastore (data and analytics layer), Beacon HQ (trial management and analytics portal), and Beacon Scientific/Clinical Study Operations services, with Beacon Pal as the patient-facing companion app. On top of this, Beacon offers a Sleep Diagnostics business acquired from CleveMed — including the SleepView Monitor (Type III home sleep testing device), SleepView Direct (mail-order HST fulfillment), and the HIPAA-compliant SleepView Web Portal with EMR integration — which was formally unified under the Beacon brand in June 2026. AI capabilities (proprietary foundation model trained on millions of hours of EEG; FDA-cleared SleepStage ML; automated arousal detection; epileptiform activity characterization) power biomarker discovery for CNS drug development across partnerships with companies including Takeda, Harmony Biosciences, UCB, and more than half of the world's top ten biopharmaceutical companies.

Differentiator

Problem solved

Functional benefit

Brands

• Waveband: FDA 510(k)-cleared at-home EEG headband (formerly Dreem 3S) that collects PSG-quality sleep EEG data for clinical trials and home use.
• SleepView
• SleepView Direct
• Beacon Platform
• Beacon Datastore
• Beacon HQ
• Beacon Pal

Products and services

• Waveband (formerly Dreem 3S) FDA 510(k)-cleared (K223539) at-home EEG headband that directly records the brain's electrical activity during sleep and wake. Equipped with 5 EEG channels (frontal F7/F8, ground Fp1, occipital O1/O2) and a 3-axis accelerometer for head movement, head position, and respiratory trace; over 24-hour battery life; raw EDF output; and Bluetooth pairing with the Beacon Pal app. PSG-equivalent sleep staging validated as performing as well as or better than human experts.
• Beacon Pal Mobile companion app that pairs with the Waveband via Bluetooth for patient-initiated EEG recordings. Offers customizable self-report questionnaires, supports six different languages, performs real-time sensor-placement verification, and transmits data over a secure, encrypted, version-controlled connection. Designed to enable caregiver or patient setup without a technologist.
• Beacon Datastore Cloud-native data management and analytics layer of the Beacon Platform. Stores millions of hours of biosignal data with version control, integrated Beacon Analytics (510(k)-cleared ML algorithms for PSG analysis, epileptiform activity characterization, standardized spectral analysis), low-latency event monitoring, third-party data integration, tokenization for privacy-preserving joins, and SOC 2 Type 2 security with US DPF / GDPR compliance and GCP-compliant retention.
• Beacon HQ Web portal that gives clinical development teams a window into the Beacon Datastore for organizing, exploring, and analyzing EEG datasets across clinical trials. Capabilities include data drill-downs by cohort/demographic/site, blinded trial site compliance monitoring, regulatory documentation export, and team data sharing/integration with external data systems.
• Beacon Clinical Study Operations Full-service team supporting device deployment, logistics, setup, low-latency compliance monitoring, data quality review, site/user training on the Beacon Pal app and study technology, and data transfer agreements to incorporate patient-reported outcomes throughout Phase 1-4 clinical trials.
• Beacon Scientific Services Expert team providing scientific strategy, endpoint advisory, measurement frequency guidance, comprehensive reporting, translational medicine interpretation, and retrospective/real-world data biomarker discovery analysis. Expertise spans neuroscience, biostatistics, signal processing, electrical engineering, and data science.
• SleepStage ML FDA 510(k)-cleared AI-powered sleep staging software that performs automated sleep staging from EEG signals, validated to perform equivalent to or better than human expert scorers. Used in conjunction with the Waveband (Dreem 3S) headband and supports the PCCP-authorized continuous algorithm enhancement pathway.
• SleepView Monitor Small, lightweight FDA-cleared Type III (also meets Type IV) HST device with 8 channels: heart rate, pulse oximetry, respiratory airflow (compatible with CPAP via cannula port up to 20 cm H2O), RIP respiratory effort belt, snore, body position, auxiliary channel, and integrated actigraphy for Total Sleep Time. Dimensions 3" x 2.6" x 0.7", 2 oz, powered by 1 AAA battery. Meets AASM and CMS clinical guidelines; SleepView Web Portal supports automated respiratory event scoring and EMR integration. 97% patient acceptance rate.
• SleepView Direct Mail-order home sleep testing fulfillment program that lets sleep centers and providers scale HST services without adding staff. Includes the SleepView Monitor, customized kit preparation, outbound and return shipping logistics, dedicated patient phone support, customizable reports through the SleepView Web Portal, and optional RPSGT manual scoring (Gold plan) with board-certified sleep physician over-read. Plans: Gold and Silver.
• SleepView Web Portal HIPAA-compliant, AASM-compliant web-based platform for centralized home sleep study management. Provides secure online access to every sleep study, automated respiratory event scoring, automatic data upload on device check-in, lifecycle admin access, centralized scoring, online reports, automatic email notifications, and SleepView Direct order management. Integrates with provider EMRs.

Quantifiable outcome

• 2M+ hours of EEG analyzed on the Beacon Platform
• +9 more outcomes

Named customers7 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability9 records

Feature11 records

Partnerships

Nine partnerships are on record, tiered flagship / strategic core and core.

• Harmony Biosciencesflagship / strategic coreStrategic or Co-development Partner · 16 December 2025Collaboration to incorporate Beacon's Waveband EEG headband and AI-driven quantitative EEG algorithms into two of Harmony's Phase 3 studies of HBS-301 for Narcolepsy and Idiopathic Hypersomnia. Combines traditional patient-reported outcomes (e.g., Epworth Sleepiness Scale) with objective EEG data across consecutive nights of sleep and daytime naps. Aims to enable more robust characterization of daytime and nighttime sleep patterns and to identify EEG biomarkers for dose selection and efficacy assessment.
• Takeda Pharmaceuticalflagship / strategic coreStrategic or Co-development Partner · 19 November 2025Multi-year expansion (Nov 2025) of Beacon's strategic collaboration with Takeda to accelerate data-driven development of sleep biomarkers and new diagnostic pathways for narcolepsy. Uses Beacon's FDA-cleared at-home EEG headband (Waveband) and AI analytics to shorten the diagnostic journey for narcolepsy NT1 patients. Beacon is eligible to receive up to $109M in data license fees plus development, regulatory, and commercial milestones, including equity participation. Builds on the original 2024 partnership.
• SyndeiocoreStrategic or Co-development Partner · 13 November 2025Named biopharma partner among Beacon's R&D collaborators leveraging AI-derived biomarkers for CNS drug development, patient selection, and precision medicine.
• CleveMedflagship / strategic coreOEM/ Whitelabel/ Licensing Partner · 21 April 2025Beacon Biosignals acquired CleveMed (a Home Sleep Testing technology and services provider) in a strategic transaction to enhance sleep testing technology and expand market access. CleveMed's SleepView and SleepView Direct home testing service were subsequently unified under the Beacon brand (announced June 2026), combining CleveMed's home sleep testing infrastructure with Beacon's AI-driven brain monitoring technology. The integrated platform is described by Beacon as the most advanced EEG-based home sleep testing platform in the U.S.
• UCBcoreStrategic or Co-development Partner · 12 December 2024Collaboration on the HEADFIRST study of sleep architecture in children with LGS using Beacon's Dreem 3S EEG headband. Findings presented at AES 2024 (REM sleep 56.77 min LGS vs 104.34 min controls; mean sleep cycles 4.6 LGS vs 2.6 controls). UCB also named among Beacon's biopharma R&D partners leveraging AI-derived biomarkers.
• Longboard PharmaceuticalscoreStrategic or Co-development Partner · 12 December 2024Collaboration on the Dreem LGS Caregiver Study using Beacon's FDA-cleared Dreem 3S EEG headband to characterize sleep disturbances in caregivers of children with LGS. Caregivers showed significantly higher Wake After Sleep Onset (37.79 min vs 24.70 min in controls).
• LGS FoundationcoreStrategic or Co-development Partner · 18 September 2024Partner on the HEADFIRST basket study evaluating the Dreem 3S/Waveband headband in pediatric patients with neurodevelopmental disorders, beginning with Lennox-Gastaut Syndrome (LGS). LGS Foundation supports recruitment and awareness for the first cohorts.
• Skye BiosciencecoreStrategic or Co-development Partner · 25 July 2024Strategic collaboration to integrate sleep quality and sleep apnea endpoints using Beacon's at-home EEG and AI platform into Skye's CBEYOND Phase 2 trial of nimacimab for obesity.
• Dreem (R&D business)flagship / strategic coreStrategic or Co-development Partner · 11 July 2023Beacon acquired Dreem's research and development business on July 11, 2023, integrating Dreem's FDA-cleared at-home sleep monitoring hardware with Beacon's AI EEG analytics platform. The transaction included an undisclosed Series A financing round led by General Catalyst. Dreem was a Paris-based sleep monitoring pioneer founded in 2014 with $57M+ prior funding.

Scale indicators16 records

Recent moves6 records

Expansion highlights8 records

Direct peers

• iRhythm Technologies: Wearable biosignal (ECG) patch with cloud-native AI analytics and a service-based diagnostic offering. Closely comparable business model to Beacon: FDA-cleared wearable + AI/ML algorithms + cloud platform + enterprise payer/provider sales, and an adjacent biosignal category (cardiac vs. brain).
• Ceribell: AI-powered point-of-care EEG and seizure detection platform sold to hospitals and clinical sites. Comparable to Beacon in the AI-on-EEG regulatory pathway (FDA-cleared algorithms, cloud-based interpretation) and in bringing objective brain biomarkers into routine clinical care.
• ActiGraph: Wearable actigraphy and digital endpoint platform used in clinical trials and academic research. Comparable to Beacon on the wearable + cloud + clinical-trial endpoint axis, particularly for sleep and activity biomarkers, though without direct EEG measurement.
• Cumulus Neuroscience: Multi-day, at-home EEG assessment platform purpose-built for CNS clinical trials. Directly comparable to Beacon's life sciences business: similar goal of replacing in-clinic EEG/PSG with remote, longitudinal brain-activity data for pharma-led trials in psychiatry and neurology.
• Cambridge Cognition: Digital cognitive assessment and CNS clinical trial endpoint company serving biopharma. Comparable to Beacon's life sciences side as a vendor of objective, scalable brain/CNS endpoints (cognitive rather than EEG, but the same biopharma R&D buyer and biomarker-discovery value proposition).

Broad incumbents

• Compumedics: Global sleep diagnostics and neurophysiology hardware and software company. Direct overlap with Beacon's SleepView/EEG business: PSG, HST, and EEG systems sold to sleep labs, hospitals, and research sites, with attached software and scoring services.
• Nox Medical: Sleep diagnostics hardware and software (PSG, HSAT, AURA) company with strong presence in sleep labs and HST providers. Comparable to Beacon's home and lab sleep testing stack, particularly the CleveMed/SleepView business, and increasingly to Beacon's cloud platform strategy.
• Natus Medical: Long-established neurodiagnostics and sleep diagnostics device maker with a broad portfolio of EEG, PSG, and HST hardware. Comparable to the CleveMed/SleepView side of Beacon in clinical-channel neurodiagnostic hardware, and to Beacon's PSG/EEG algorithm stack through Natus' competing clinical offerings.
• Verily (an Alphabet company): Alphabet-owned precision health and sleep/brain health business (including the Verily Study Watch and earlier sleep efforts). Comparable to Beacon in its ambition to build a multi-modal, at-home, AI-driven brain/cardiac data platform for clinical research, but with vastly larger capital and distribution.
• Itamar Medical (a ZOLL/ResMed company): Home sleep testing and cardiology diagnostics (WatchPAT) provider acquired by ZOLL/ResMed. Closely comparable to CleveMed/SleepView in the at-home HST category and to Beacon's direct-to-provider sleep diagnostics channel, with similar reimbursement and sleep physician buyer profiles.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/biosignals
• LinkedInlinkedin.com/company/beacon-biosignals

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles17 records

Subsidiaries2 records

Funding overview

Funding rounds4 records

Investors16 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Beacon Biosignals