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HoneyNaps Receives U.S. FDA Approval for Groundbreaking AI Sleep Disorder Diagnosis Software

Reported by PR Newswire / Sep 25, 2023



HoneyNaps, the leading-edge AI-based sleep disorder diagnosis software company, has announced that its SOMNUM AI sleep disease analysis algorithm has been approved by the U.S. Food and Drug Administration (FDA).



AI and medical devices are a sought-after combination, but the FDA has granted only two approvals for sleep disease diagnosis solutions by U.S. companies. HoneyNaps is the first Korean company and identify their FDA approval as a demonstration of their technology's capabilities. By integrating the latest AI research trends with diagnostic algorithms based on multi-channel/time series sleep biosignal data rather than by reading video images, HoneyNaps is paving the way for the future of AI in healthcare.


Sleep biosignals tend to include electroencephalograms, electrooculograms, chin and leg electromyograms, electrocardiograms, respiratory airflow and effort, oxygen saturation, posture, and snoring, and these are monitored continuously during sleep for assessing sleep status and sleep disorder diagnosis via polysomnography.


The process of reading these results can take up to three to four hours by skilled personnel. To overcome the obstacles of staffing and time, AI reading systems have become highly researched. The complex and heterogeneous nature of biosignals lends to a high level of difficulty when it comes to improving such AI systems to a level that yields the same output as a human.


HoneyNaps' AI solution for diagnosing sleep disorders, 'SOMNUM,' transcends conventional video image reading systems for biosignals. It leverages deep learning-based AI to perform real-time analysis of vast volumes of multi-channel/time series biosignals, setting a new standard for accuracy and transparency in the field. SOMNUM's development is underpinned by the pioneering eXplainable Medical AI (XAI) technology.


Professor Ji Ho Choi, Head of the Centre for Sleep Medicine at Soonchunhyang University Bucheon Hospital, 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. Furthermore, with the continuous improvement of biosignals AI reading technology, it will be possible to detect or predict some cardiovascular, neurological, and muscular diseases beyond the diagnosis of sleep disorders."


Numerous studies using SOMNUM have been presented at international conferences as part of presentations such as "A robust hybrid algorithm for automatic respiratory events scoring in adults" at Sleep 2023, and "Validation study of neural network algorithm for automated sleep stage scoring" at World Sleep 2019, held by the World Sleep Society (WSS). In addition, the study "Validation study on automated sleep stage scoring using a deep learning algorithm" was published in an SCIE journal.


Tae Kyoung Ha, General Representative Director at HoneyNaps, 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 U.S. 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."

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