Reported by komedi.com / Aug 19, 2023
“Next goal is to obtain domestic and CE certifications, planning to further enhance the technology in areas such as cardiovascular function”
The sleep analysis algorithm 'SOMNUM' developed by HoneyNaps, a specialized AI sleep diagnostic SW company, has obtained approval from the U.S. Food and Drug Administration (FDA) on the 16th (local time). This makes it the third sleep disorder diagnostic solution to receive FDA approval worldwide, following Enso Data and Cerebra Medical in the United States, and the first achievement for a South Korean company.
HoneyNaps stated, "As the U.S. FDA has strengthened its scrutiny of AI-based medical devices, we underwent the validation phase, including the evaluation of effectiveness on 400 U.S. citizen patients, directly rather than through a third-party agency. As a result, we successfully passed the review process within three years."
SOMNUM, developed by HoneyNaps, is a diagnostic algorithm based on multi-channel/time-series biosignal data, rather than image interpretation. It is expected to bring about a new change in the sleep diagnosis market, which has been predominantly focused on image-based AI. HoneyNaps explained that this is a case that effectively incorporates the latest trends in AI research, demonstrating the technological capabilities of domestic medical solutions.
SOMNUM offers faster and more accurate analysis compared to human sleep experts. It is powered by deep learning-based AI, enabling real-time analysis of multi-channel and large-scale data.
HoneyNaps, aiming to become the first publicly listed sleep tech company in South Korea, is reportedly in discussions for an underwriting contract based on their FDA-approved AI technology and global business model.
A HoneyNaps representative stated, "We will further enhance our technology with the addition of diagnostic capabilities for cardiovascular and cerebrovascular diseases. Along with this, we will expedite our global market expansion through domestic and CE certifications, utilizing the 'Innovative Medical Device Track'."
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