Noxturnal Web
Nox Medical ehfNoxturnal Web is a web-based software designed to display, analyze, and manually score pre-recorded physiological data collected during sleep studies. It assists clinicians in diagnosing sleep and respiratory-related disorders by enabling detailed review and reporting of sleep stages and breathing events such as obstructive apneas, all under clinical supervision.
Intended Use
Noxturnal Web is indicated for use in the displaying, analysis and printing of pre-recorded biophysical parameters acquired during sleep for the purpose of assisting in the diagnosis of sleep and respiratory-related sleep disorders in adults only.
Technology
Noxturnal Web is a web-based Software as a Medical Device (SaMD) that operates in the cloud, processes pre-recorded physiological data from sleep studies, and provides manual scoring functionalities including visualization, annotation, calculation of AASM standardized indices (e.g., AHI), and report generation. It does not record data itself but provides an analysis platform equivalent to predicate device software DOMINO.
Performance
Software verification and validation testing were performed according to IEC 62304 and related FDA-recognized standards, demonstrating safety and effectiveness with passing results. The device's performance was validated through comparative analysis against predicate software and bench testing without reliance on clinical data.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/7/2024
7 months - 2
FDA Approval
12/23/2024
Other devices from Nox Medical ehf
- DeepRESP2025 • 510K
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