HoneyNaps wins FDA clearance for AI sleep analysis device
July 17, 2026 | 10:31(0) user say
HoneyNaps received US FDA 510(k) clearance, designated K253390, for SOMNUM V3.0, validating AI-based classification of sleep-disordered breathing subtypes and supporting next-generation digital biomarker development.
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
According to validation results submitted as part of the FDA clearance process, the algorithms achieved Overall Percent Agreement (OPA) of more than 97% across respiratory event categories, supporting the software’s performance in automated event detection and classification
The company is also developing next-generation AI technologies and digital biomarkers, including Hypoxic Burden (HB), Arousal Burden (AB), and Ventilatory Burden (VB), to enable more comprehensive evaluation of disease severity and health risks associated with sleep apnea. HoneyNaps plans to pursue additional FDA 510(k) clearances for future SOMNUM versions incorporating these capabilities
Sean Ha (Tae Kyoung Ha), President of HoneyNaps USA, stated, “The FDA 510(k) clearance for SOMNUM V3.0 represents regulatory validation of our AI algorithm’s clinical performance in automatically detecting and differentiating OSA, CSA, and MSA. We remain focused on advancing AI-driven sleep diagnostics through continued innovation in automated analysis and next-generation digital biomarkers.”
Website: www.honeynaps.com
Tag:HoneyNapsFDA clearance sleepAI sleep analysis
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