Onera SleepMap

by Onera B.V.  · Based in Netherlands → — Transforming sleep diagnostics with clinical-grade, at-home polysomnography.
Neurology Pulmonology Sleep Medicine
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Per-test pricing
Regulatory Status Disclosed

Overview

Onera SleepMap, part of the Onera Sleep Test System (STS), is an AI-powered sleep analysis software designed to process polysomnography (PSG) data. Onera Health, a spin-off from the imec research center, aims to revolutionize sleep diagnostics by making clinical-grade sleep studies more accessible, convenient, and user-friendly. The Onera Sleep Test System (STS) is a patch-based, wireless sensor system that allows patients to conduct comprehensive sleep studies in the comfort of their own homes or in a clinical setting. This system records multiple physiological signals, including brain, respiratory, and cardiac functions, matching the clinical accuracy of in-lab PSG tests. The self-applied patches are designed for ease of use, with a setup time of less than five minutes. The data is then sent to a cloud-based platform where clinicians can remotely monitor, analyze, and diagnose patients.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered sleep analysis software
  • Processes polysomnography (PSG) data
  • Patch-based, no-wire sensor system
  • Clinical-grade PSG diagnostics
  • At-home and in-lab use
  • Measures multiple physiological parameters (EEG, EOG, EMG, ECG, respiratory effort, respiratory flow, oxygen saturation, activity, position, sound pressure level)
  • Cloud-based platform for data management, analysis, and diagnosis
  • User-friendly design with quick setup (less than 5 minutes)
  • Data storage up to 16 hours
  • Integrates with Somnoware sleep lab management software

Use Cases

  • Diagnosing sleep disorders (e.g., sleep apnea, insomnia, narcolepsy)
  • Remote patient monitoring for sleep health
  • Expanding sleep programs for clinics and hospitals
  • Reducing patient wait times for sleep studies
  • Facilitating sleep studies for pilots and Aviation Medical Examiners (AMEs)
  • Providing comprehensive sleep test data in various clinical and non-clinical environments

What Physicians Need to Know

EEG Interpretation AI
Onera SleepMap utilizes machine learning algorithms to monitor and analyze sleep data, distilling it into simple reports for doctors to interpret. The system records brain signals with an EEG, providing a more accurate assessment of sleep. This AI-powered analysis aims to make it easier and more time-effective for clinicians to diagnose sleep disorders. While Onera's AI assists in data analysis and report generation, the diagnosis and interpretation of the report are ultimately performed by the doctors. The system's ability to automatically detect sleep stages using EEG signals has shown high classification performance, comparable to using multiple EEG channels.
Seizure Detection
While Onera SleepMap focuses on sleep diagnostics, the broader field of AI in neurology shows promise for seizure detection and forecasting using wearable devices and sleep features. Studies have explored using smart shirts to analyze sleep features and train classifiers to forecast seizure days, achieving above-chance performance in a significant percentage of patients. This suggests a potential for non-invasive seizure forecasting and personalized patient follow-ups.
Neurodegenerative Disease Screening
A novel AI model, developed in collaboration with Cleveland Clinic and IBM, can use information from routine sleep studies to identify patients' long-term health risks, including those related to cognitive decline and neurodegenerative diseases. This AI can detect latent physiological features invisible to the human eye, extracting prognostic biomarkers to stratify risk for neurological disease. A pilot study also evaluated the diagnostic agreement for sleep biomarker-based neurodegenerative disorder risk probabilities in patients with Alzheimer's disease dementia, Lewy body disease, and mild cognitive impairment.
Triage Prioritization Speed
Onera SleepMap aims to simplify and expedite the sleep diagnostics process, making it easier and more affordable for both doctors and patients. The patch-based system significantly reduces setup time, averaging less than five minutes, which can contribute to faster patient throughput. By enabling at-home polysomnography, it addresses bottlenecks in traditional sleep labs, potentially reducing waiting lists and accelerating diagnosis.
Mobile Notification System
Onera's system is wireless and patch-based, allowing patients to move around freely during the sleep study. The Onera Digital Health Platform connects the sleep studies, enabling easy management by multiple stakeholders from any computer and secure data direction within networks of clinics and providers. While not explicitly a 'mobile notification system' for urgent medical events, the cloud-based platform facilitates efficient data access and management, which can support timely clinical decisions.
Physician Tip

Onera SleepMap offers a significant advancement in sleep diagnostics by providing a user-friendly, patch-based polysomnography (PSG) system that can be used at home or in a clinical setting. This can greatly improve patient comfort and adherence to testing, while also expanding access to gold-standard sleep studies. The AI-powered analysis of the comprehensive PSG data helps distill complex information into actionable reports, empowering clinicians to make more efficient and accurate diagnoses. The system's ability to monitor treatment efficacy over time is also a valuable tool for managing chronic sleep disorders. Remember that while the AI assists in data analysis, the ultimate diagnosis and interpretation remain the physician's responsibility. The integration with existing sleep lab management software like Somnoware further streamlines workflows.

Onera SleepMap integrates with the Onera Digital Health Platform, a cloud-based system that allows for the management of sleep studies by multiple stakeholders and secure data transfer within healthcare networks. The Onera hPSG solution also integrates with Somnoware by ResMed sleep lab management software, enabling clinicians to access study results for review, interpretation, and management through a single platform workflow, eliminating manual file transfers. The system delivers EDF files via its cloud platform, ensuring compatibility with commonly used sleep analysis software.

Details

Category Neurology AI
Pricing Per-test pricing — Predictable per-test pricing; no upfront investment for providers
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Cleared AI-estimated

The Onera Sleep Test System (Onera STS) received 510(k) market clearance from the U.S. Food & Drug Administration (FDA) in April 2022 for use in the United States. The FDA determined that Onera's product was substantially equivalent to a polysomnography (PSG) system marketed by Natus Medical Inc.
Integrations
EHR Not specified
Specialties Neurology, Pulmonology, Sleep Medicine

What the Web Says

Onera SleepMap, also known as the Onera Sleep Test System (STS), is a wireless, patch-based home polysomnography (hPSG) system designed to provide clinical-grade sleep diagnostics outside of a traditional lab setting. Recent multicenter validation studies have shown its performance to be comparable to in-lab polysomnography for sleep staging and respiratory event detection, addressing the growing demand for sleep studies and resource constraints in healthcare. The system aims to make gold-standard sleep testing more accessible and convenient for patients.

Overall: Mixed

Strengths

  • Comparable accuracy to in-lab polysomnography for sleep staging and respiratory event detection.
  • Wireless, patch-based, and user-friendly design for at-home use.
  • Significantly improves access to comprehensive sleep diagnostics.
  • Quick setup time, averaging less than five minutes.
  • Designed for minimal sleep disturbances during recording.
  • Provides full polysomnography signal set.

Limitations

  • Some Reddit users express skepticism about the accuracy of home sleep studies in general, with some recommending in-lab studies for more reliable results.
  • One Reddit review for a similar product (Orion Sleep System, which also offers a sleep test) mentioned that the sleep insights were often inaccurate and lacked depth, failing to correctly track sleep and wake times or periods of being out of bed.
  • The validation study population was primarily composed of individuals with mild obesity and lacked reported racial diversity, which could influence the generalizability of SpO2 measurements.
  • The validation study did not evaluate patient-led, self-application of the device in a home setting, which is subject to ongoing research.
  • A Reddit review for a similar product noted issues with software and connectivity, making the unit uncontrollable without an internet connection and lacking physical controls.

Based on reviews from: Respiratory Therapy, Clinical Trials Arena, Xtalks, Onera Health Website, Sleep Review, Reddit (r/Orion_Sleep), Reddit (r/SleepApnea)

Last updated: 2026-08-19

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Press & Coverage

FDA
K253668 - 510(k) Premarket Notification - Onera SleepMap (SLEEPMAP)
Onera B.V. received FDA 510(k) clearance for its Onera SleepMap system, an automated EEG device, on March 8, 2026. This regulatory announcement details the premarket notification for the device, classified as 'Automatic Event Detection Software For Polysomnograph With Electroencephalograph'.
2026-03
Mordor Intelligence
Electro-Diagnostic Devices Market Share & Analysis 2026-2033
This market analysis highlights Onera B.V.'s receipt of FDA 510(k) clearance for its Onera SleepMap system in March 2026, noting it as an automated EEG device. The report discusses trends in the electro-diagnostic devices market, including a shift towards portable and home-based devices.
2026-06
FDA
Medical Devices that Incorporate Sensor-based Digital Health Technology
The FDA lists Onera SleepMap (SLEEPMAP) by Onera B.V. as a neurology device that incorporates sensor-based digital health technology, with a final decision date of March 8, 2026. This resource provides transparency for healthcare providers and patients regarding authorized sDHT medical devices.
2026-06
FDA
Artificial Intelligence-Enabled Medical Devices
Onera SleepMap (SLEEPMAP) from Onera B.V. is included in the FDA's list of Artificial Intelligence-Enabled Medical Devices, with a decision date of March 6, 2026. This list aims to provide insights into the current landscape and regulatory expectations for AI-enabled medical devices.
2026-06
HealthAIdir
Onera SleepMap Review, Pricing & Alternatives
HealthAIdir lists Onera SleepMap as a Phase 7 candidate from the FDA AI-enabled medical devices list, identifying Onera as the maker and Neurology as the panel.
2026-06
LinkedIn
Onera Health | LinkedIn
Onera SleepMap assists clinicians in reviewing and overscoring sleep study data.
2026-07
Kipra
510(k) K253668 - Onera SleepMap (SLEEPMAP)
This entry details the 510(k) premarket notification for Onera SleepMap (SLEEPMAP) by Onera B.V., with a decision date of March 8, 2026. The device is categorized under product code OLZ.
2026-03
FDA
TPLC - Total Product Life Cycle - Onera B.V.
This FDA Total Product Life Cycle (TPLC) entry for Onera B.V. includes information related to the Onera SleepMap (K253668), indicating a 'Substantially Equivalent' decision.
2026-08

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Frequently Asked Questions

Onera SleepMap is a patch-based, Type II polysomnography (PSG) system designed to capture a comprehensive set of physiological signals, including brain activity (EEG), cardiovascular, and respiratory functions. Unlike many HSATs that offer limited data, Onera SleepMap provides gold-standard quality, clinical-grade PSG diagnostics, which is crucial for detecting neurological sleep disorders and assessing sleep architecture.
Onera SleepMap (specifically the Onera STS System) has received 510(k) FDA clearance in the United States and the Onera STS I System is CE marked in Europe, indicating it meets regulatory standards for medical devices. Onera's Digital Health Platform is designed for secure management of sleep studies, with data securely directed within networks of clinics and providers. Their privacy policy outlines data collection, usage, and security measures, including compliance with GDPR for EU residents.
Onera SleepMap offers the advantage of being a no-wire, patch-based system that can be self-applied at home, enhancing patient comfort and convenience, and potentially leading to more representative sleep data. Studies have shown it performs comparably to in-lab PSG for sleep staging and respiratory event detection. However, while it provides comprehensive PSG data, the interpretation and diagnosis still rely on expert clinical review.
While Onera SleepMap itself provides the raw PSG data, the broader field of AI in sleep medicine is advancing to identify subtle physiological patterns in sleep study data that can predict risks for neurological disorders and cognitive decline, beyond conventional scoring. Onera's 'as-a-service' model aims to leverage machine learning and AI to help pinpoint issues and streamline the diagnostic process for clinicians.
Onera offers a 'PSG as-a-service' model, which includes a full-service clinical-grade polysomnography solution with full cost-control and a fixed fee per study, eliminating the need for upfront investment. This model aims to make comprehensive sleep diagnostics more accessible and efficient for clinics.
Onera SleepMap is designed to integrate with existing clinical workflows. The clinician requests the PSG through the Onera Digital Health Platform, and the generated reports are compatible with commonly used sleep analysis software for review and diagnosis. Onera has also announced integration with platforms like Somnoware, allowing clinicians to manage home sleep studies through a single platform.
While traditional HSATs are available, they often lack the comprehensive physiological data needed for neurological sleep disorders. Other home polysomnography solutions are emerging that aim to capture the same breadth of signals as in-lab studies. For example, some systems like SleepImage use a wearable ring to record multiple channels of data, including heart rate, respiration, and blood oxygenation, with reported high agreement with in-lab tests.

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Suggest an Edit → | Last Verified: 2026-08-19 | First Added: 2026-08-19
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