Onera Health

What Onera Health does

Onera Health is a Netherlands-based medical device company, spun off from imec in 2017, that develops a wireless, patch-based polysomnography (PSG) system for clinical-grade sleep diagnostics. The core product, the Onera Sleep Test System (STS), consists of four self-applied, no-wire sensors placed on the forehead, upper chest, abdomen, and lower leg that together capture a 15-channel PSG signal set (EEG, EOG, EMG, respiratory airflow and effort via bioimpedance, SaO2, ECG, snoring, body position, and leg movements). Data is processed on the cloud-based Onera Digital Health Platform, which generates EDF files, standardized scoring, and reports compatible with common sleep-analysis software.

The company operates a PSG-as-a-Service commercial model, charging clinicians a fixed fee per study with no upfront capital investment, and serves sleep clinics, hospitals without dedicated sleep labs, and integrated healthcare systems. Distribution is direct in the United States and Europe, with strategic US channel partnerships including MedBridge Healthcare (April 2023) and a June 2026 integration with Somnoware by ResMed sleep lab management software. The product is CE-marked (Class IIa) in Europe and FDA 510(k)-cleared in the United States, with clinical validity demonstrated in a 206-participant, 7-site multicenter study published in the Journal of Clinical Sleep Medicine showing concordance correlation coefficients of 0.88-0.94 versus gold-standard in-lab PSG. The company has raised over €50M across disclosed rounds (Series A $9.3M in 2019, Series B €10.5M in 2021, Series C €30M+ in January 2024) from a syndicate including Innovation Industries, EQT Life Sciences, Gimv, Jazz Pharmaceuticals, imec.xpand, Invest-NL, and BOM.

Name

Onera Health

Legal name

Onera Technologies B.V.

Website

https://onerahealth.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

Onera Health is a Netherlands-based medical device company developing a wireless, patch-based polysomnography system and cloud platform that enables clinicians to conduct clinical-grade home sleep studies on a per-study fee basis, serving sleep clinics, hospitals, and healthcare systems across Europe and the United States.

Ownership category

akta.pro rank

Product category

Sleep Diagnostics and Polysomnography

NAICS

Home Health Care Services (621610), Computer Systems Design and Related Services (54151)

SIC

Instruments For Meas & Testing Of Electricity & Elec Signals (3825), Services-Home Health Care Services (8082), Services-Misc Health & Allied Services, Nec (8090)

akta.pro primary industry

Sleep Diagnostics & Monitoring (PSG/Home Sleep Testing, Actigraphy) (HLAHAGAB)

akta.pro secondary industries

Remote Diagnostics & Home Testing Devices (Connected POC/At-Home Diagnostic Readers) (HLAHACAL), Pulmonology & Sleep Medicine Telemedicine Platforms (HLALAGAF), Diagnostic & Triage Decision Support (HLACAGAA)

Keywords

• Polysomnography systems
• Home sleep diagnostics
• Medical sensor technology
• Clinical sleep monitoring
• Wireless PSG devices

Headquarters

HQ city

Eindhoven

HQ country

Netherlands

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. PSG-as-a-Service: Subscription-like service model with fixed fee per sleep study. Clinicians request PSG via Onera Digital Health Platform; Onera delivers sensors to patient; data is processed and analyzed generating a report. No upfront investment required from clinics.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Onera Health develops and sells the Onera Sleep Test System (STS), a patch-based wireless polysomnography (PSG) sensor system combined with the cloud-based Onera Digital Health Platform. Delivered as PSG-as-a-Service with fixed fee per study and no upfront investment, the solution enables clinical-grade sleep diagnostics in hospital, sleep lab, or home settings via four self-applied no-wire sensors capturing a 15-channel PSG signal set.

Product overview

Onera Health offers a unified PSG-as-a-Service platform centered on the Onera hPSG® solution, which combines the Onera Sleep Test System (STS) hardware with the Onera Digital Health Platform. The STS uses a patch-based sensor system with four no-wire sensors (applied to forehead, upper chest, abdominal area, and lower leg) that capture a full 15-channel PSG signal set including EEG, EOG, EMG, respiratory measurements, ECG, and more. The cloud-based Digital Health Platform processes signals, generates EDF files, and enables standardized scoring and reporting. The company operates under two regulatory versions: Onera STS I (CE marked for Europe) and Onera STS System (FDA 510(k) cleared for the US), both Class IIa medical devices. Pricing is structured as a fixed fee per study with no upfront investment required.

Differentiator

Problem solved

Functional benefit

Brands

• Onera hPSG: End-to-end home polysomnography solution
• Onera STS
• Onera PSG-as-a-Service
• Onera Digital Health Platform

Products and services

• Onera hPSG® End-to-end home polysomnography solution providing comprehensive sleep diagnostics through four wireless, patient-applied sensors that capture a 15-channel PSG dataset. Enables clinical-grade PSG testing in the patient's home environment.
• Onera Sleep Test System (STS) Patch-based sensor system that captures all signals required for Polysomnography (PSG) with a no-wire, user-friendly design. The system includes a reusable Pod and disposable Patches that can be self-applied by patients at home.
• Onera Digital Health Platform Cloud-based platform that enables PSG signal processing, analysis, and management of sleep studies. Provides EDF file delivery, standardized scoring and reporting, and is compatible with common sleep analysis software.
• Onera PSG-as-a-Service Full-service diagnostic and monitoring solution combining Onera's patch-based sensor hardware with cloud-based platform services. Provides fixed-fee per study pricing with no upfront investment required, enabling clinicians to conduct PSG anytime, anywhere.

Quantifiable outcome

• Set up time reduced from 28+ minutes (traditional PSG) to under 5 minutes
• +4 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability2 records

Feature4 records

Partnerships

Two partnerships are on record, tiered core.

• SomnowarecoreTechnology or Integration · 15 June 2026Integration of Onera hPSG® solution with Somnoware by ResMed sleep lab management software. Enables clinicians to conduct PSG tests in patients' homes while managing the entire workflow in Somnoware. Study results available directly in Somnoware for review, interpretation, and management, eliminating manual file transfers or platform switching.
• MedBridge HealthcarecoreStrategic or Co-development PartnerStrategic partnership announced April 4, 2023 to deliver the first self-applied, no-wire polysomnography solution in the US market. MedBridge Healthcare serves as a strategic partner for US market penetration.

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Nox Medical: Iceland-based maker of the Nox A1 PSG system and related home sleep diagnostics. Direct competitor offering ambulatory PSG hardware targeting sleep clinics and research labs.
• Compumedics: Australia-based manufacturer of clinical PSG systems (Somté, Grael) used in sleep labs worldwide. Competes with Onera in the clinical-grade PSG hardware segment.
• SOMNOmedics: German developer of PSG and home sleep testing systems (SOMNOwatch, SOMNOscreen). Direct European peer competing in ambulatory sleep diagnostics.
• Cadwell Industries: US-based manufacturer of PSG systems and neurodiagnostic equipment. Competes with Onera in clinical PSG hardware targeting sleep labs and hospitals.
• Itamar Medical (ZOLL Itamar): Maker of the WatchPAT home sleep apnea testing device. Direct competitor in the home sleep diagnostics category, now part of ZOLL Medical.
• CleveMed: US-based maker of home sleep testing devices (SleepView). Competes with Onera in the simplified home sleep apnea testing segment.

Broad incumbents

• ResMed: Global leader in sleep apnea treatment (CPAP) and owner of Somnoware sleep lab management software. Serves as both an integration partner and broad competitive incumbent across sleep medicine.
• Philips: Broad incumbent in sleep diagnostics and therapy via the Alice PSG line and CPAP portfolio. Large hospital sales footprint and broader medtech portfolio make it a formidable competitor.
• Natus Medical: Established provider of neurodiagnostic and sleep diagnostics equipment. Competes in the PSG hardware and clinical sleep lab segment with a broader neurology portfolio.

Emerging players

• BMC Medical: Chinese manufacturer of home sleep testing devices and respiratory care equipment. Emerging player with overlap in home-based sleep diagnostics, particularly in APAC markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/onerahealth

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds6 records

Investors11 records

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

M&A

Investments

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

Frequently asked questions about Onera Health