DeepRESP
Nox Medical ehfDeepRESP is a cloud-based AI software tool that analyzes sleep study recordings, with or without EEG signals, to assist clinicians in diagnosing sleep disorders. It automatically marks events, calculates parameters like the Apnea-Hypopnea Index, and infers sleep stages. This helps medical professionals to efficiently assess sleep health and tailor treatments.
Intended Use
DeepRESP is an aid in the diagnosis of various sleep disorders where subjects are often evaluated during the initiation or follow-up of treatment. It processes signals from sleep studies performed in hospital, home, or ambulatory settings in adults 22 years and older, intended for use by medical professionals.
Technology
DeepRESP is a cloud-based SaMD comprising a web API for integration with client applications, predefined AI and rule-based analytic protocols for scoring sleep studies, and storage for output results. It analyzes sleep study recordings, including EEG and other physiological signals, to derive sleep staging, respiratory event scoring, and calculation of clinical parameters like AHI.
Performance
Clinical performance was validated in retrospective studies using over 5,700 sleep recordings with manual scoring as reference. DeepRESP demonstrated non-inferiority or superiority in scoring sleep stages and respiratory events compared to predicate devices, for both recordings with and without EEG. Performance met predefined clinical endpoints ensuring safety and efficacy. Software was verified per IEC 62304 and FDA software validation guidance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/3/2024
8 months - 2
FDA Approval
3/14/2025
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