HoneyNaps has received U.S. FDA 510(k) clearance for SOMNUM V3.0, its AI-based clinical decision support software for polysomnography analysis.
The clearance, under FDA 510(k) number K253390, expands SOMNUM’s capabilities in sleep-disordered breathing analysis. The software is designed to assist medical professionals in analysing polysomnography data, including sleep staging and respiratory event detection.
This is relevant because sleep-disordered breathing remains a major diagnostic burden for sleep centres and clinicians. Manual scoring of polysomnography studies can be time-consuming, and differentiating respiratory event subtypes may require careful interpretation of multi-channel physiological signals.
SOMNUM V3.0 automatically detects apnea and hypopnea events and classifies apnea into obstructive sleep apnea, central sleep apnea and mixed sleep apnea using AI algorithms. Compared with approaches that mainly use composite indices, the software provides event-level classification intended to support more detailed clinical scoring.
According to validation results submitted as part of the FDA clearance process, the algorithms achieved overall percent agreement of more than 97 per cent across respiratory event categories. The reported agreement rates were 98.58 per cent for hypopnea, 97.42 per cent for obstructive apnea, 99.83 per cent for central apnea and 99.94 per cent for mixed apnea.
The ability to distinguish apnea subtypes is clinically important because obstructive, central and mixed sleep apnea may have different underlying mechanisms and management considerations. More precise event classification could support clearer diagnostic interpretation and treatment planning.
HoneyNaps is also developing additional AI technologies and digital biomarkers, including hypoxic burden, arousal burden and ventilatory burden. These are intended to support more comprehensive evaluation of disease severity and health risks associated with sleep apnea in future releases.
The company said additional FDA 510(k) clearances are planned for later SOMNUM versions incorporating these capabilities. This suggests HoneyNaps is building SOMNUM as a broader sleep diagnostics platform rather than a single-function scoring tool.e
