AI Sleep Diagnostics

Honeynaps Received U.S. FDA Clearence for Its Ai-Powered Diagnostic Software

HoneyNaps received U.S. FDA 510(k) clearance for SOMNUM V3.0, an AI-powered diagnostic software platform designed to assist clinicians with polysomnography analysis. The system automatically detects apnea and hypopnea events and classifies apnea as obstructive, central or mixed using AI algorithms.

Validation data submitted to the FDA showed more than 97% Overall Percent Agreement across respiratory event categories. HoneyNaps previously received 510(k) clearance for SOMNUM V1.1.2 and plans to pursue additional approvals for future versions capable of detecting digital biomarkers including hypoxic burden, arousal burden and ventilatory burden.

For clinicians, SOMNUM V3.0 can reduce the manual workload involved in reviewing sleep-study data while standardizing respiratory event analysis. The clearance reflects continued adoption of AI-assisted diagnostic tools designed to streamline specialist workflows and support more consistent clinical interpretation.

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