HoneyNaps Receives U.S. FDA 510(k) Clearance for SOMNUM V3.0 for AI-Based Sleep-Disordered Breathing Analysis

BOSTON, July 16, 2026 /PRNewswire/ -- HoneyNaps, an AI-based sleep medicine company, today announced that SOMNUM V3.0, its AI diagnosis software for polysomnography (PSG) analysis, has received U.S. Food and Drug Administration (FDA) clearance under clearance number K253390.

SOMNUM is clinical decision support software designed to assist medical professionals in analyzing PSG data, including sleep staging and respiratory event detection. HoneyNaps previously received FDA clearance for SOMNUM V1.1.2, and the latest clearance expands the software’s capabilities for automated analysis of sleep-disordered breathing (SDB).

SOMNUM V3.0 automatically detects apnea and hypopnea events and classifies apnea into Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA), and Mixed Sleep Apnea (MSA) using AI algorithms. Compared with conventional approaches that primarily assess SDB using composite indices, the software provides event-level classification intended to support more detailed clinical scoring.

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