SEOUL, Aug. 21 (Yonhap) — South Korean digital health care startup HoneyNaps Co. announced on Monday that its AI-powered sleep sensing software, Somnum, has been given the green light by the U.S. Food and Drug Administration (FDA).
The FDA’s Section 510(k) clearance, or premarket notification, demonstrates that the medical device is safe and effective, and thus does not require premarket approval before being available for sale.
This marks the first time a sleep analysis solution developed by a South Korean firm has been approved by the FDA. Two U.S. companies — EnsoData’s EnsoSleep and Cerebra Medical’s Cerebra Sleep System — have also been given the FDA clearance.
“The FDA has toughened its review process of AI-based health care products,” HoneyNaps said in a release. “We have conducted clinical trials in the U.S. for the past three years to meet the FDA criteria.”
Somnum is software with an AI algorithm that collects and analyzes sleep data, mainly the vital signs of its user, and predicts disease by applying it to a clinical data set. Its AI has been trained with more than 18 million sets of related data over the past eight years.
HoneyNaps said the FDA approval will help the company go public in South Korea and put more effort into expanding its business horizons to cerebral and cardiovascular diseases.