SomnoMetry
Neumetry Medical IncSomnoMetry, developed by Neumetry Medical Inc, is an AI-powered software that helps clinicians analyze sleep studies by automatically scoring physiological signals from polysomnography tests. It aids in diagnosing sleep quality and respiratory sleep disorders such as obstructive apnea, facilitating more efficient and accurate sleep study evaluations under clinical supervision.
Intended Use
SomnoMetry is intended for use for the diagnostic evaluation by a physician to assess sleep quality and as an aid for diagnosis of sleep and respiratory-related sleep disorders in adults. It automatically scores sleep study results including staging of sleep, AHI, and detection of sleep-disordered breathing events including obstructive apneas under clinician supervision.
Technology
SomnoMetry employs signal processing, data indexing, conventional machine learning, and deep learning algorithms to analyze polysomnography physiological signals automatically. It includes web API for data upload, AI/ML engine for analysis, databases for data storage, a dashboard for review and verification, and report generation capabilities.
Performance
Performance testing included software verification and validation, retrospective clinical study with 201 polysomnography files from accredited sleep facilities, demonstrating scoring and diagnostic performance substantially equivalent to the predicate device EnsoSleep (K162627). Clinical evaluation confirmed safety, effectiveness, and non-inferiority in sleep staging and diagnosing sleep apnea across adult age groups.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/25/2022
4 months - 2
FDA Approval
9/21/2022
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