HoneyNaps Receives U.S. FDA 510(k) Clearance for SOMNUM V3.0 for AI-Based Sleep-Disordered Breathing Analysis
– FDA 510(k) Clearance (K253390) Validates AI-Based Classification of OSA, CSA, and MSA
– Subtype-Specific Respiratory Event Analysis Improves Diagnostic Precision and Supports Next-Generation Digital Biomarker Development
– Advanced AI Analysis Using Multi-Channel Physiological Signals, with Additional FDA 510(k) Clearances Planned for Future Releases
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.
Key Enhancements in SOMNUM V3.0
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.
By analyzing subtle physiological patterns from multi-channel biosignals, SOMNUM V3.0 is designed to distinguish different apnea subtypes that may be challenging to differentiate through manual scoring alone. HoneyNaps believes this capability may support more accurate assessment of sleep-disordered breathing severity and assist clinicians in treatment planning.
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.”
For further information, please contact:
HoneyNaps USA, Inc.
Christine Kwon / Managing Director
Email: sleep@honeynaps.com
Address: 14th Floor, One Broadway, Cambridge, MA 02142, USA
Website: www.honeynaps.com