SPASS, a Korean company specializing in artificial intelligence (AI) medical solutions, said its AI-based sepsis diagnosis solution, SpassageQ, has received FDA 510(k) clearance, also known as pre-market notification, local news reports said.

The approval of the AI-based sepsis diagnosis software, SpassageQ, demonstrates that the field of medical AI solutions in Korea can be expanded to analyze patient vital signs instead of medical images alone.

It is also the first time in Korea that a signaling medical device other than image reading has been approved by the FDA.

Under the FDA regulations, SpassageQ was approved as a software as a medical device (SaMD) that proactively detects sepsis, anaphylaxis, and hypovolemic shock, in recognition of its innovative research and development capabilities. 

"The FDA barrier was higher than we thought, and we had a lot of trial and error because no other consulting company in Korea had experience with SaMD," local news reports quoted SPASS CEO Kim Yong-hwan as saying. "We are very pleased that we passed the audit in two years through our own internal certification team and hard work."

The company is a promising start-up with offices in Canada and Korea, operating in partnership with the Catholic University of Korea.