HoneyNaps Receives U.S. FDA Approval for Groundbreaking AI Sleep Disorder Diagnosis Software
SEOUL, South Korea, Sept. 25, 2023 /PRNewswire/ -- 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).
- SEOUL, South Korea, Sept. 25, 2023 /PRNewswire/ -- 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.
- 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.