HoneyNaps, the AI-based sleep disorder diagnosis software company, has announced that its SOMNUM AI sleep disease analysis algorithm has been approved by the US Food and Drug Administration (FDA).
The FDA has granted only two approvals for sleep disease diagnosis solutions by US companies and HoneyNaps is the first Korean company to receive this status and identify their FDA approval as a demonstration of their technology’s capabilities.
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.
HoneyNaps ‘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.
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 US citizens directly, rather than through an agency, from the validation stage.”