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FDA Clears HoneyNaps’ AI-Powered Sleep-Scoring Software

Reported by Sleep Review / Sep 25, 2023



[SOMNUM measures biosignals in real time to deliver fast, accurate diagnostic information for providers.]


The US Food and Drug Administration (FDA) has granted 510(k) clearance to South Korea-based HoneyNaps’ SOMNUM artificial intelligence (AI)-powered sleep disorder analysis algorithm.


SOMNUM leverages deep learning-based AI to perform real-time analysis of vast volumes of multi-channel/time series biosignals to deliver fast, accurate diagnostic information for providers, according to a release from the company.


“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,” says Tae Kyoung Ha, general representative director at HoneyNaps, in a release. “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.”


With traditional polysomnography, analyzing results can take up to three to four hours by skilled personnel. Due to time and staffing challenges, there’s a growing focus on AI systems. 


“In the future, AI reading technology for biosignals is expected to play a very important role, similar to AI autonomous driving technology in cars,” says Ji Ho Choi, MD, PhD, head of the center for sleep medicine at Soonchunhyang University Bucheon Hospital, in a release. “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. In addition, the study “Validation study on automated sleep stage scoring using a deep learning algorithm” was published in Medicina.


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