SomnoMetry

by Neumetry Medical  · Based in United States → — Instant Predictive Care
Neurology Pulmonology Sleep Medicine
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Regulatory Status Disclosed

Overview

SomnoMetry, developed by Neumetry Medical, is an FDA-cleared Artificial Intelligent/Machine Learning (AI/ML)-based Software as a Medical Device (SaMD) designed to automatically score sleep study results. It analyzes polysomnography (PSG) signals using a broad array of signal processing, data indexing, conventional machine learning, and deep learning algorithms.

The software provides actionable clinical insights for the assessment of sleep quality and aids in the diagnosis of sleep and respiratory-related sleep disorders in adults. SomnoMetry is intended for use under the supervision of a clinician in a clinical environment, with all automatically scored events subject to verification by a qualified clinician.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automatic event detection for polysomnography with electroencephalography
  • Real-time analysis of sleep data
  • Comprehensive sleep study reporting
  • Integration with existing sleep diagnostic equipment
  • User-friendly interface for clinicians
  • Data visualization tools for sleep metrics
  • Patient data management and storage
  • Secure data transmission and storage
  • Compliance with healthcare data security standards
  • Web API for data upload

Use Cases

  • Automated scoring of polysomnography (PSG) signals
  • Diagnostic evaluation for sleep quality assessment
  • Aid in the diagnosis of sleep disorders in adults
  • Aid in the diagnosis of respiratory-related sleep disorders in adults
  • Enhancing efficiency and accuracy of sleep disorder diagnosis
  • Gaining actionable insights from sleep health data

What Physicians Need to Know

EEG Interpretation AI
SomnoMetry utilizes AI/ML algorithms for automatic event detection within polysomnography, which includes electroencephalography (EEG) signals, to provide actionable clinical insights for sleep quality assessment and diagnosis of sleep and respiratory-related sleep disorders.
Seizure Detection
Not explicitly mentioned as a primary function. SomnoMetry is FDA-cleared for assessing sleep quality and aiding in the diagnosis of sleep and respiratory-related sleep disorders, not for seizure detection.
Triage Prioritization Speed
SomnoMetry enhances the efficiency and accuracy of diagnosing sleep disorders by automating sleep study scoring, which can indirectly speed up the diagnostic process for sleep-related conditions.
Mobile Notification System
Optional modules include a mobile app for patients. The broader Neumetry platform also mentions immediate notification when readings move to a risk zone, which could be applicable to sleep data if integrated.
Physician Tip

SomnoMetry is an FDA-cleared AI-driven software designed to automate the scoring of polysomnography (PSG) signals, significantly enhancing the efficiency and accuracy of sleep study interpretation. While the AI provides comprehensive scoring and clinical insights, physician oversight and verification of all automatically scored events remain crucial for accurate diagnosis and treatment planning for sleep and respiratory-related sleep disorders.

SomnoMetry offers a web API for data upload and is designed for integration with existing sleep diagnostic equipment. It also supports integration with major Electronic Health Record (EHR) systems like Epic, as well as billing systems and various EEG devices.

Details

Category Neurology AI
Pricing Contact vendor — Contact vendor
DeploymentSaaS; on prem; hybrid
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

SomnoMetry is an FDA-cleared Artificial Intelligent/Machine Learning (AI/ML)-enabled Software as a Medical Device (SaMD) that automatically scores sleep study results by analyzing polysomnography (PSG) signals. It is intended for use for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults only.
Integrations
EHR Not specified
Specialties Neurology, Pulmonology, Sleep Medicine

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Press & Coverage

FDA
K221179 - SomnoMetry 510(k) Premarket Notification
The FDA cleared SomnoMetry, a software-only medical device by Neumetry Medical Inc., for diagnostic evaluation of sleep quality and aid in diagnosing sleep and respiratory-related sleep disorders in adults. It automatically scores sleep study results, including sleep staging, AHI, and detection of sleep-disordered breathing events.
2022-09
PMC (via OTO Open)
New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2022
This review highlights SomnoMetry (Neumetry) as an autoscoring AI/ML software that analyzes and scores sleep study results, noting that while it automates a portion of the study, a trained physician must still verify and analyze the results.
2024-01
ResearchGate (via IQVIA Institute for Human Data Science)
Digital Health Trends 2024: Implications for Research and Patient Care
Neumetry Medical's SomnoMetry is listed among various digital health products for diagnosing, treating, and remotely monitoring patients, indicating its presence in the evolving digital health market.
2023-10
FDA
CDRH Premarket Authorizations that Used Real-World Evidence
The FDA lists SomnoMetry (Neumetry Medical Inc.) as a device that utilized real-world evidence from medical records for its 510(k) clearance, specifically using archived polysomnography files to compare device performance to manual clinician scoring.
2026-06
Neumetry
SomnoMetry Product Page
SomnoMetry is presented as an FDA-cleared AI/ML-based Software as a Medical Device (SaMD) that automatically scores sleep study results, utilizing various algorithms for actionable clinical insights.
unknown
HealthAidb
Alternative products to Cadence Health Analytics
SomnoMetry by Neumetry Medical is identified as an alternative product in the clinical care, diagnostic support, and patient-facing categories of health software.
unknown

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Frequently Asked Questions

SomnoMetry is an FDA-cleared AI/ML-based Software as a Medical Device (SaMD) that automatically scores polysomnography (PSG) signals to provide clinical insights for diagnosing sleep and respiratory-related sleep disorders in adults. It streamlines the sleep staging process and event detection, allowing clinicians to review and verify AI-generated scores rather than performing manual scoring from scratch, thereby enhancing efficiency and consistency.
As an FDA-cleared SaMD, SomnoMetry has met specific regulatory standards for safety and effectiveness. However, healthcare organizations must ensure compliance with HIPAA and evolving state AI laws, which require safeguarding Protected Health Information (PHI), obtaining explicit consent for data usage, and potentially de-identifying data before AI input.
SomnoMetry is designed to automate the scoring of PSG signals, which is the gold standard for sleep assessment, and its performance has been demonstrated to be substantially equivalent to predicate devices. While traditional PSG is labor-intensive, AI tools like SomnoMetry aim to improve diagnostic consistency and throughput, and some AI-powered HSATs are also emerging to detect sleep apnea with clinical-grade accuracy.
Specific pricing for SomnoMetry is not publicly detailed, but similar AI sleep scoring solutions offer per-study pricing models, which can vary based on volume. The broader AI-powered sleep technologies market is experiencing rapid growth, driven by the demand for cost-effective and efficient diagnostic solutions, suggesting potential for insurance coverage as these technologies become more integrated into clinical practice.
Limitations include the potential for AI algorithms to amplify biases present in their training data, which could affect generalizability across diverse patient populations. Additionally, AI tools are intended to assist, not replace, human clinicians, requiring ongoing professional oversight and validation of results to ensure accurate interpretation and ethical implementation.
SomnoMetry, as an FDA-cleared device, likely adheres to rigorous development and validation guidelines, including data handling and model development. However, the responsibility for ethical use extends to the clinician, who must ensure informed consent for data usage, adhere to privacy regulations like HIPAA, and critically review AI outputs for potential biases, especially concerning diverse patient populations.
While SomnoMetry primarily focuses on automating sleep study scoring and detecting events like obstructive apneas, AI in sleep medicine is evolving to offer more personalized insights. Advanced AI models are being developed to analyze extensive datasets to identify patient endotypes, predict treatment responsiveness, and provide a more comprehensive risk profile beyond the traditional Apnea-Hypopnea Index (AHI).

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