Noxturnal Web

Noxturnal Web is a web-based software-only medical device that enables physicians to display, analyze, and print pre-recorded sleep study data for diagnosing sleep and respiratory-related sleep disorders in adults. Users access sleep study recordings stored in the cloud, then manually score the data for sleep stages, arousals, respiratory events, and other parameters to generate clinical reports.

Noxturnal Web is a cloud-based web application (requiring no installation) that provides manual scoring workflows for sleep study data, supporting the same physiological signal inputs (EEG, EOG, EMG, ECG, airflow, respiratory effort, oxygen saturation) and calculating identical AASM standardized indices as the predicates. Unlike the primary predicate SOMNOscreen plus, Noxturnal Web contains no hardware for recording signals—it is purely a software analysis tool—and like the additional predicate SomnoMetry, it operates as a web-based platform rather than a desktop application.

IEC 62304 Edition 1.1 (medical device software lifecycle), ANSI AAMI ISO 14971:2019 (risk management), IEC 82304-1 (health software), ISO 20417 (labeling), IEC/ANSI 60601-1:2005 (general safety), EN 60601-1-2:2015 (EMC), IEC 62366-1:2015 (usability), and AAMI TIR57:2016 (cybersecurity). The American Academy of Sleep Medicine (AASM) Manual for Scoring of Sleep and Associated Events was used as the clinical standard.

Noxturnal Web shares identical intended use with the predicates—assisting in diagnosis of sleep and respiratory disorders through analysis of pre-recorded physiological signals in adult patients. The core functionality is the same: both manual scoring workflows support sleep stage classification (W, N1/N2/N3, REM), respiratory and arousal event marking, and AASM index calculation with report generation. Although Noxturnal Web lacks the hardware recording component of SOMNOscreen plus and uses web-based delivery like SomnoMetry, these differences affect form factor, not clinical function or safety; the comparative analysis and software verification/validation testing confirm identical signal processing, scoring algorithms, and output parameters, demonstrating no new safety or effectiveness concerns.