The FDA formally approves the AI-based SOMNUM technology. Credit: HoneyNaps/PRNewswire.

HoneyNaps has received approval from the US Food and Drug Administration (FDA) for its artificial intelligence (AI) sleep disease analysis algorithm, SOMNUM.

The new software surpasses conventional video image-based biosignal analysis systems in diagnosing sleep disorders.

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Leveraging deep learning-based AI, it will carry out real-time analysis of large volumes of multi-channel and time-series biosignals.

HoneyNaps general representative director Tae Kyoung Ha said: “The FDA has recently strengthened its review of AI-based medical devices and we passed the review in three years by conducting clinical trials with 400 subjects, including US citizens directly, rather than through an agency, from the validation stage.

“This is an opportunity for us to further enhance our technology, such as adding diagnostic functions for cardiovascular and neuromuscular diseases and to accelerate our expansion into the global market.”

Polysomnography helps monitor sleep biosignals, including electrooculograms, electroencephalograms, electrocardiograms, chin and leg electromyograms, oxygen saturation, respiratory airflow and effort, posture and snoring.

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This comprehensive monitoring helps assess sleep quality and diagnose sleep disorders. Skilled personnel may require three to four hours to analyse these results.

Soonchunhyang University Bucheon Hospital’s Centre for Sleep Medicine head professor Ji Ho Choi said: “Like the AlphaGo case, which defeated humanity, this FDA approval is a very important event and a turning point in the field of sleep medicine in Korea.

“In the future, AI reading technology for biosignals is expected to play a very important role, similar to AI autonomous driving technology in cars.”