credit : SPASS,

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.

SPASS, a company specializing in artificial intelligence medical solutions, said on Tuesday that its AI-based sepsis diagnosis solution, SpassageQ, has received 510(k) approval also known as pre-market notification from the FDA. 

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 the FDA has approved a signaling medical device other than image reading.

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."

Founded in 2017, SPASS was selected as the "Baby Unicorn 200 Promotion Project" by the Ministry of SMEs and Startups in Korea and has been backed by 5 billion won through Stone Bridge Ventures. 

SPASS, which has been focused on global R&D established an artificial intelligence (AI) laboratory in Toronto, Canada, in 2020. In November last year, based on the achievements of the Toronto AI Research Institute, it was selected through fierce competition for the FastLane AI cohort, a promising AI startup support program of the Vector Institute, a Canadian national research institute. 

Jong-ok Ko, CEO of Happysona, a Canadian AI accelerator that actively supported SPASS' global expansion, said, "SPASS' medical product planning and execution ability have been evaluated at a global level from the beginning. If the latest AI research trends are effectively combined, Korea's medical solution sector will grow faster worldwide."