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FDA Approves AI Sleep Disorder Diagnosis Software

Reported by PharmExec / Sep 29, 2023



Korean-based company HoneyNaps developed the algorithm.



HoneyNaps announced that its AI-powered sleep disorder diagnosis algorithm has been approved by FDA.


According to a press release, the algorithm, named Somnum AI, combines AI with diagnostic algorithms that analyze multi-channel/time series sleep biosignal data. The algorithm does not use video images in its analysis.


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


He continued, “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."


The algorithm analyzes data on various biosignals, such as electroencephalograms, electrooculograms, chin and leg electromyograms, electrocardiograms, respiratory airflow and effort, oxygen saturation, posture, and snoring.

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