Korean startup SPASS gets FDA clearance for AI-based sepsis diagnosis solution

Korean AI medical solutions company, SPASS, announced that its AI-based sepsis diagnosis solution, SpassageQ, has received FDA 510(k) clearance. The approval marks a significant milestone for medical AI solutions in Korea, expanding the capability to analyze patient vital signs beyond medical images. This is the first time the FDA approved a signaling medical device in Korea besides image reading.

Under the FDA regulations, SpassageQ was approved as a medical device (SaMD) software that proactively detects sepsis, anaphylaxis, and hypovolemic shock.

CEO Kim Yong-hwan expressed satisfaction with passing the FDA barrier, “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. The approval was achieved in two years through SPASS’s internal certification team’s dedicated efforts.

Established in 2017, SPASS was selected for the “Baby Unicorn 200 Promotion Project” by the Korean Ministry of SMEs and Startups, receiving substantial backing from Stone Bridge Ventures. With a focus on global R&D, SPASS set up an AI laboratory in Toronto, Canada, in 2020.

The company’s achievements earned it a place in the FastLane AI cohort of the Vector Institute, a prestigious Canadian national research institute. SPASS stands out among global companies, participating in Vector Research’s “Casual Inference” research as the sole Korean startup.

Ko Jong-ok, 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.”

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