Medical device company DIALTEC is experiencing a significant surge in its stock price following the announcement of a new X-ray product. The rise is attributed to the recent 510(k) certification from the U.S. Food and Drug Administration (FDA), which has heightened expectations for the company's expansion into the U.S. market.
As of 9:43 a.m. on October 19, DIALTEC's shares were trading at 4,265 won, up 930 won (27.89%) from the previous trading day. The stock initially hit its daily limit before retracting some of its gains.
The surge in DIALTEC's stock is linked to the news of its new product launch. The company announced that its next-generation digital X-ray system, the New EXSYS DEXi, has received FDA 510(k) certification.
This product combines DIALTEC's proprietary X-ray generator, digital X-ray detector, image processing, and system control technology. According to the company, it enhances user convenience and imaging efficiency based on its previous product development experience.
With the FDA certification of the New EXSYS DEXi, DIALTEC plans to strengthen its sales efforts targeting medical institutions and diagnostic imaging equipment distribution networks worldwide, including the United States. The company also aims to expand its customer base across various medical facilities, including orthopedic and general radiology departments and health screening centers.
Previously, DIALTEC launched its EXSYS DEXi human X-ray system in 2024. With the introduction of the New EXSYS DEXi, the company intends to broaden its existing business model of supplying single detector products in the U.S. market to include a comprehensive solution that encompasses detectors, generators, image processing, and systems.
As of 9:43 a.m. on October 19, DIALTEC's shares were trading at 4,265 won, up 930 won (27.89%) from the previous trading day. The stock initially hit its daily limit before retracting some of its gains.
The surge in DIALTEC's stock is linked to the news of its new product launch. The company announced that its next-generation digital X-ray system, the New EXSYS DEXi, has received FDA 510(k) certification.
This product combines DIALTEC's proprietary X-ray generator, digital X-ray detector, image processing, and system control technology. According to the company, it enhances user convenience and imaging efficiency based on its previous product development experience.
With the FDA certification of the New EXSYS DEXi, DIALTEC plans to strengthen its sales efforts targeting medical institutions and diagnostic imaging equipment distribution networks worldwide, including the United States. The company also aims to expand its customer base across various medical facilities, including orthopedic and general radiology departments and health screening centers.
Previously, DIALTEC launched its EXSYS DEXi human X-ray system in 2024. With the introduction of the New EXSYS DEXi, the company intends to broaden its existing business model of supplying single detector products in the U.S. market to include a comprehensive solution that encompasses detectors, generators, image processing, and systems.
* This article has been translated by AI.
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