Finemedix, a company specializing in gastrointestinal endoscopic procedure instruments, announced on the 2nd that its second-generation tissue acquisition instrument, "ClearTip (ClearTip EUS-FNA/B)," has received 510(k) approval from the U.S. Food and Drug Administration (FDA).
With this approval, the company's total number of FDA-approved products has increased to 12.
ClearTip is an instrument used in fine-needle aspiration (FNA/B) for collecting tissue samples for lesion diagnosis during endoscopic ultrasound (EUS) examinations, and it is a key product driving the company's overseas sales.
Finemedix succeeded in the first commercialization of its first-generation product in 2017, breaking into a market dominated by global corporations with domestic technology. It then introduced the world's first second generation with a button-type structure in 2023. The company noted, "ClearTip has significantly improved visibility and collection efficiency for endoscopic ultrasound procedures by applying ergonomic design."
The company plans to leverage the expanded FDA approval to accelerate overseas sales growth and increase its market share in the U.S., currently conducting final negotiations with distribution partners for full-scale sales in the United States.
Jeon Sung-woo, CEO of Finemedix, said, "This FDA approval is not just a sales authorization; it officially recognizes the excellence of our products in the global market," adding, "It will be a catalyst for accelerating partner cooperation and market expansion." Jeon also mentioned, "We will continue to develop innovative products that reflect the demands of the medical field to strengthen our position in the global endoscopic procedure instrument market."
Finemedix was listed on the KOSDAQ market last December. Founded by Jeon, a former gastroenterologist, in 2009 to break the monopoly structure of overseas companies, it has independently developed and produced six product lines, 23 products, and 234 models, supplying them to 45 companies in 51 countries including the U.S., Europe, and Asia.