EnsoSleep

by EnsoData  · Based in United States →Optimize the Sleep Lab Workflow
Neurology Pulmonology Sleep Medicine

Starting at $9.50 per month
Regulatory Status Disclosed

Overview

EnsoSleep is an FDA-cleared, AI-powered, cloud-based solution designed to simplify and accelerate the sleep testing, diagnosis, and treatment workflow for health systems, hospitals, and independent sleep labs. It provides a single platform for viewing, scoring, editing, and reporting of both in-lab Polysomnography (PSG) and Home Sleep Apnea Tests (HSATs).

The AI-assisted scoring automates event detection, including sleep staging, arousals, leg movements, and sleep-disordered breathing events like obstructive apneas, central apneas, and hypopneas. This automation significantly reduces the time sleep technologists and clinicians spend on manual scoring, with reported time savings averaging 62% for PSGs and 68% for HSATs.

EnsoSleep also includes features like EnsoHST™, which accelerates the analysis of photoplethysmogram (PPG) signals from pulse oximeters for sleep-disordered breathing, and the ability to produce accurate Total Sleep Time (TST) for HSAT devices that don’t inherently calculate it, improving diagnostic accuracy and potential reimbursements.

The platform is compatible with leading sleep medicine devices, offers seamless integrations, and prioritizes data confidentiality, availability, and integrity. It is built on a secure infrastructure that is HIPAA compliant and SOC 2 Type II Certified.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-assisted scoring for PSGs and HSATs
  • Cloud-based study management platform
  • Viewing, editing, and reporting of sleep studies
  • Automated event detection (sleep staging, arousals, leg movements, SDB events)
  • EnsoHSTu2122 for PPG signal analysis from pulse oximeters
  • Accurate Total Sleep Time (TST) for HSATs
  • Workflow automation and efficiency improvements
  • Customizable reports and dynamic reporting
  • Data import/export capabilities
  • Third-party integrations and HL7 connectivity

Use Cases

  • Accelerating diagnosis and treatment of sleep disorders
  • Reducing manual sleep study scoring time for technologists
  • Improving consistency and accuracy of sleep study scoring
  • Expanding patient care capacity and outreach for sleep labs
  • Optimizing sleep lab operations and workflow management
  • Supporting diagnosis of sleep apnea and respiratory-related sleep disorders

What Physicians Need to Know

Evidence Base
EnsoSleep is FDA-cleared (initially in 2017, with subsequent clearances in 2021 and 2024 for new features and pediatric use). It adheres to American Academy of Sleep Medicine (AASM) scoring guidelines. The AI/Machine Learning algorithms are continuously maintained, tested, and validated, having learned from over 2.5 million RPSGT-scored and reviewed sleep studies. It analyzes physiological signals for sleep staging, respiratory events, arousal events, movement events, and cardiac events in both adult and pediatric patients (ages 13 and up).
Clinical Validation Studies
Extensive clinical validation studies have been conducted, including a significant one in 2020 with a large, diverse, and representative dataset. Validation compares EnsoSleep's AI scoring to a prospective, double-blind 2/3 Majority Scoring panel consensus of independent, qualified sleep technologists. Studies have validated performance for Sleep Staging, Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA), Hypopneas, Arousals, Limb Movements, Cheyne-Stokes Respiration, and Periodic Breathing Episodes across various AHI severity categories. Overall agreement levels for EnsoSleep AI scoring are reported as >93% for diagnostic AHI, >86% for sleep staging, and >94% for disordered breathing events. EnsoHST (part of EnsoSleep PPG) demonstrates >92% sensitivity for detecting sleep apnea at 3% desaturation and an average difference of 5.5 minutes in Total Sleep Time compared to PSG. Research also includes studies on AI analysis of PPG-based sleep-wake staging, Total Sleep Time, respiratory rate, and bias analyses for skin color assessments.
Override Rate Data
Clinicians are able to review and edit the AI-scored studies. Changes made by technologists often do not result in a change to a patient's AHI severity group, suggesting a high initial accuracy of the AI. Specific quantifiable override rate data (i.e., a percentage of how often clinicians modify the AI's initial scores) is not explicitly provided.
Differential Diagnosis Support
EnsoSleep aids in the diagnostic evaluation by providing automated and consistent scoring of various sleep events (e.g., OSA, CSA, hypopneas, arousals, limb movements) and calculating indices like AHI. This comprehensive data helps physicians assess sleep quality and identify the correct AHI severity level. However, the device itself does not interpret results or suggest a diagnosis; it marks events for physician review.
Guideline Update Frequency
EnsoSleep's AI/ML algorithms are regularly maintained, tested, and validated over time. The device aims to identify physiological events according to the latest sleep scoring rules, procedures, and definitions under current AASM standards of care. A specific frequency for guideline updates (e.g., quarterly, annually) is not explicitly stated, but continuous adherence and maintenance are emphasized.
Clinical Workflow Integration
EnsoSleep is a cloud-based platform for viewing, scoring, editing, and reporting Polysomnograms (PSGs) and Home Sleep Apnea Tests (HSATs). It is compatible with most leading PSG and HSAT hardware/software platforms and integrates seamlessly into existing sleep lab workflows. The system works in the background, automatically detecting studies, analyzing them, and uploading the scored studies back into the native software. This process significantly reduces manual scoring time (average 62% for PSGs and 68% for HSATs). It allows remote access to studies without a VPN and provides automated email reminders to physicians with direct links for review. Physician changes are dynamic and reflected in reports in real-time. EnsoSleep also integrates with ePrescribing platforms like Parachute Health to streamline the ordering workflow.
Physician Tip

Leverage EnsoSleep's AI-powered scoring to significantly reduce manual review time for PSGs and HSATs, allowing more focus on patient education, complex cases, and treatment planning. Utilize the consistent and standardized AI scoring to enhance confidence in diagnostic results, especially for HSATs with the accurate Total Sleep Time (TST) feature. Take advantage of the cloud-based platform for flexible, remote access to studies and streamlined reporting, improving overall workflow efficiency and patient turnaround times. Remember that while the AI provides a highly accurate first pass, final diagnosis and treatment decisions remain the physician's responsibility after review and any necessary edits.

EnsoSleep is designed for seamless integration with a wide array of leading PSG and HSAT devices and existing sleep lab software platforms. It operates in the background, automating the initial scoring process and returning the AI-analyzed data to your native system. Additionally, it offers integration with ePrescribing platforms, such as Parachute Health, to further streamline the post-diagnosis treatment ordering workflow.

Details

Category Clinical Decision Support & Reference, Neurology AI
Pricing Starting at $9.50 per month
  • Usage-based, per month
  • Volume discounts available based on minimum monthly commitment
  • Example pricing: PSG/Month: 1 ($16.50), 100 ($16.00), 300 ($15.00), 500 ($14.00), 1000 ($12.00); HSAT/Month: 1 ($8.25), 100 ($8.00), 300 ($7.50), 500 ($7.00), 1000 ($6.00)
  • EnsoTST and EnsoViewer are optional add-on products for additional cost
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

EnsoSleep received its initial FDA 510(k) clearance in 2017 for diagnostic analysis of in-lab sleep studies in adults. It received expanded FDA 510(k) clearance (K210034) on June 8, 2021, to include scoring and analysis of home sleep studies, a browser-based viewing, editing, and reporting platform, and support for pediatric patients aged 13 and older, as well as detection of Cheyne-Stokes respiration and periodic breathing episodes. The latest FDA 510(k) clearance in February 2024 (EnsoSleep PPG) enables AI-driven analysis using photoplethysmogram (PPG) signals from FDA-cleared pulse oximeters.

Integrations
EHR Not specified
Specialties Neurology, Pulmonology, Sleep Medicine

What the Web Says

EnsoSleep is an FDA-cleared, AI-powered, cloud-based solution that automates the scoring and management of sleep studies, including both polysomnography (PSG) and home sleep apnea tests (HSATs). It aims to streamline workflows, reduce scoring times, and improve the consistency and accuracy of sleep study analysis for healthcare providers. The software is designed to be user-friendly for sleep technologists and physicians, allowing them to focus more on patient care and increasing testing volume.

Overall: Positive

Strengths

  • Significantly decreases sleep study scoring times, often within 15 minutes.
  • High accuracy in AI scoring, with reported 95% accuracy for pediatric event detection and 93% overall diagnostic AHI agreement for adults.
  • Easy to use and integrates well with existing sleep systems and third-party data transfer systems.
  • Improves consistency of staging and scoring, leading to increased physician satisfaction.
  • Excellent customer service and responsive support team.
  • Helps manage increased testing volume without needing additional staff, saving time and money.

Limitations

  • Some users report the need to re-score tests after AI processing, particularly for respiratory events with artifact or for mixed apneas.
  • Initial integration with EMR systems like EPIC has been reported as poor due to lack of coordination with internal IT departments.
  • Software upgrades have occasionally corrupted event values.
  • Cost for use has increased, impacting previous cost savings.
  • The software is set to score based on one saved montage, and may not recognize changes to the initial sleep montage.
  • Limited reviews available on platforms like G2 for comprehensive buying insight.

Based on reviews from: Capterra, Software Advice, G2, YouTube, Sleep Review, SoftwareWorld, EnsoData, Philadelphia Sleep Conference

Last updated: 2026-07-18

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Press & Coverage

PR Newswire
Latest EnsoData FDA 510(k) Clearance Enables AI-Powered Sleep Diagnosis Using Pulse Oximetry Devices
EnsoData received FDA 510(k) clearance for technology that enables AI-powered sleep diagnosis using FDA-cleared pulse oximetry devices, expanding the capabilities of EnsoSleep PPG. This allows for more accessible and cost-effective sleep disorder diagnosis, particularly for sleep apnea.
2024-02
Sleep Review
FDA Clears EnsoData's AI Technology for Sleep Diagnosis with Pulse Oximetry
The FDA granted EnsoData 510(k) clearance for AI-powered sleep diagnosis using pulse oximetry devices, building on previous clearances for EnsoSleep. This advancement aims to accelerate the identification and treatment of sleep-disordered breathing events like sleep apnea.
2024-02
EnsoData
EnsoData, Nonin Partner to Offer Affordable, Non-Invasive at Home Sleep Testing for Patients at Risk of Sleep Apnea
EnsoData and Nonin announced a partnership to provide affordable, non-invasive at-home sleep testing for sleep apnea patients, combining EnsoHST software with Nonin's WristOx2u00ae Model 3150. This collaboration aims to improve access to quality sleep care and address the large undiagnosed patient population.
2024-08
EnsoData
EnsoDatau2122 Raises $20M Series B to Expand Commercial Team
EnsoData secured $20 million in Series B financing led by Questa Capital to accelerate the adoption of its AI-powered sleep medicine solutions. This funding will expand their commercial team and improve the sleep care pathway for millions suffering from sleep apnea.
2025-06
EnsoData
EnsoData Announces Collaboration with Takeda to Improve Narcolepsy Type 1 Diagnostic Journey Using AI Tools and Technology
EnsoData is collaborating with Takeda to develop and validate AI-based polysomnography (PSG) algorithms for more accurate and scalable diagnosis of narcolepsy type 1 (NT1). This partnership aims to address the unmet need for timely NT1 diagnosis.
2025-08
Sleep Review
EnsoData partners with ABM to add Positional Data to EnsoSleep PPG
EnsoData partnered with Advanced Brain Monitoring (ABM) to integrate positional data from ABM's Night Shift sleep positioner into the EnsoSleep PPG home sleep test. This enhancement provides more comprehensive diagnostic insights for positional obstructive sleep apnea.
2025-05
PubMed (Journal of Clinical Sleep Medicine)
Validation of an artificial intelligence based single-channel photoplethysmography home sleep apnea test
This study validates EnsoSleep PPG (ePPG), an AI-powered software, against gold-standard polysomnography for home sleep apnea testing. The research demonstrates that ePPG is non-inferior to other HSAT options as an aid in OSA diagnosis, with high sensitivity and specificity.
2026-02
Taylor & Francis (Expert Review of Medical Devices)
Current and novel device-led approaches for targeted obstructive sleep apnea screening, diagnosis, treatment, and long-term management
This review article discusses novel devices and technologies, including EnsoSleep, that are transforming the screening, diagnosis, treatment, and long-term management of obstructive sleep apnea. It highlights the role of AI/ML models in enhancing clinical practice and improving patient outcomes.
2026-02

Videos

Product demos, reviews, and walkthroughs for EnsoSleep.

View all on YouTube

Frequently Asked Questions

EnsoSleep is an FDA-cleared, cloud-based AI solution that automates the scoring of in-lab polysomnography (PSG) and home sleep apnea tests (HSATs), including sleep staging and event detection. Physicians can then review, edit, and generate reports for these AI-scored studies within a single platform, streamlining the diagnostic process and reducing manual scoring time.
EnsoSleep is FDA-cleared for use in adults and pediatric patients aged 13 and above, including recent clearance for AI-powered sleep diagnosis using pulse oximeters (EnsoSleep PPG). It also holds AASM Autoscoring Certificationu2122 and is HIPAA compliant, with its infrastructure built on ClearDATA, which is HITRUST and SOC 2 Type II Certified.
While highly accurate, EnsoSleep may have some limitations, such as potential difficulties in distinguishing central versus obstructive events in studies with significant artifact, and it does not currently score mixed events, requiring manual adjustment. Physicians are ultimately responsible for diagnoses, as the software marks events for review but does not interpret results or suggest diagnoses.
EnsoSleep is designed to significantly reduce the time spent on manual scoring of PSGs and HSATs, with reported time savings of 62% for PSGs and 68% for HSATs over manual methods. It boasts high agreement levels for diagnostic AHI (>93%) and sleep staging (>86%), and is considered by some users to be superior to other AI scoring products in accuracy.
EnsoSleep generally offers volume-based pricing with discounts available for higher monthly commitments of PSGs and HSATs. While specific costs can vary, users have reported that EnsoSleep saves time and money for their labs by increasing efficiency and reducing scoring backlogs.
EnsoData prioritizes data confidentiality, availability, and integrity, building its products on ClearDATA, an infrastructure security provider that is HIPAA compliant and HITRUST and SOC 2 Type II Certified. The platform incorporates various security measures including two-factor authentication, layered authorization, at-rest and in-transit encryption, and cryptographic hashing.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

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