World-Class Automatic Organ Recognition Technology.. Accelerating Growth as a Global Medical AI Company
Oncosoft, a specialized medical AI company in radiation therapy, announced on February 28 that its AI-based automatic contouring solution ‘OncoStudio’ obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Since obtaining approval from the Korean Ministry of Food and Drug Safety (MFDS) in 2022, OncoStudio has been adopted by 18 hospitals, including leading institutions such as Severance Hospital and Samsung Medical Center. Through real-world clinical use, its efficacy has been thoroughly validated. With this FDA 510(k) clearance, Oncosoft has now officially secured recognition for the safety and effectiveness of its solution in the U.S. market.
According to the company, OncoStudio features world-class AI-powered organ and tissue recognition technology. The solution is engineered to precisely analyze multiple body regions and automatically generate contours, significantly enhancing efficiency in radiation therapy planning. Oncosoft is also integrating Large Language Models (LLMs) and advanced AI technologies to enable AI-powered contouring not only for organs at risk (requiring radiation protection) but also for tumors, expanding the scope of automated treatment planning.
"With this FDA 510(k) clearance, we are accelerating our expansion into the U.S. market," said a company representative. "We will strengthen partnerships with American hospitals currently using our solution for research purposes and expedite regulatory approvals for key global markets, including Japan (PMDA), Europe (CE), and Southeast Asia."
Additionally, Oncosoft is actively pursuing medical device approvals in Singapore and the UAE, where its solution is already in use under research agreements.
“This FDA 510(k) clearance marks a significant milestone, granting Oncosoft official authorization to commercialize its solution in the world’s largest medical device market.” the representative added. “Following our first exhibition at ASTRO (American Society for Radiation Oncology) in 2024, we plan to showcase Oncosoft and our expanded pipeline at ASTRO 2025 in San Francisco.”
