FDA 510(k) Clearance for AI-Based Software to Assist in the Diagnosis of Sleep Disorders

HoneyNaps announced that the Food and Drug Administration (FDA) has granted the company 510(k) clearance to market SOMNUM (HoneyNaps, Seoul, South Korea) in the United States. SOMNUM is a deep learning artificial intelligence (AI)-based algorithm that analyzes sleep biosignal data obtained from polysomnography records in real-time to provide information to health care providers, assisting in the diagnosis of sleep and respiratory-related sleep disorders in adults.

According to HoneyNaps, SOMNUM processes large volumes of multi-channel/time series biosignal data, achieving a high level of analytical accuracy and transparency. This algorithm is intended to overcome the staffing and time requirements associated with traditional analysis of sleep biosignals, including:

• Sleep stage events: Wake, Stage N1, Stage N2, Stage N3, Stage REM
• Respiratory events: Sleep-disordered breathing
• Arousal events
• Leg movement events: Periodic leg movements during sleep

HoneyNaps is the first Korean company to receive FDA 510(k) clearance for an AI-based sleep biosignal analysis software.