HoneyNaps, an AI-driven sleep-medicine technology company, announced that its AI-based sleep disorder diagnostic support software, SOMNUM, which recently received clearance from the U.S. Food and Drug Administration (FDA), is significantly reducing clinical trial timelines and costs for pharmaceutical and medical device companies through enhanced data-analysis efficiency.

SOMNUM is a medical AI software solution designed to automatically analyse polysomnography (PSG) data. The system identifies sleep stages and key events—including apnea, hypopnea, and arousals—using advanced artificial intelligence–based PSG scoring.

Following its FDA 510(k) clearance last year, SOMNUM™ has been formally recognised as a validated analytical tool for sleep-related clinical trials and medical device evaluations. This clearance underscores the safety and reliability of AI-based sleep-analysis technology as acknowledged by global regulatory authorities.

Traditionally, PSG scoring required specialists to manually review and classify data for more than three to four hours per case, resulting in high labour and time costs. SOMNUM automates this process, shortening scoring time to just minutes, while clinicians review and verify the results to maintain diagnostic quality.

By integrating SOMNUM, pharmaceutical companies and medical device manufacturers have been able to accelerate clinical trial pipelines, increase data-processing speed by more than 70 per cent, and reduce overall study timelines by approximately 50 per cent. Scoring labour costs and quality-control (QC) expenses have also dropped by 80–90 per cent.

HoneyNaps is expanding its global clinical-market presence with SOMNUM at the core of its business strategy. The company is currently in discussions with U.S. pharmaceutical firms regarding the application of SOMNUM™ in sleep-related clinical studies and has established strategic partnerships with multiple CROs. Through these collaborations, HoneyNaps provides a large-scale biosignal-analysis platform essential for sleep medicine and neurological clinical trials—delivering both accelerated pipelines and enhanced data accuracy.

The company is also offering an AI-based re-scoring (verification scoring) service for already-scored PSG datasets. This new business model provides an objective check on the accuracy of existing scoring results. CROs leverage this re-scoring solution to secure data quality while shortening trial timelines and strengthening the reliability of data submitted to regulatory bodies. Beyond simple verification, the service supports clients in advancing future projects, proprietary algorithms, and technology development—ultimately enhancing R&D competitiveness.