[INQ. NO. 2511E03] Vieworks, a specialist in medical and industrial imaging solutions, recently announced that its digital medical-image acquisition and processing software, VXvue, has received permission-approval (510K) from the U.S. Food and Drug Administration (FDA).
Vieworks is the first company to receive FDA approval for software that incorporates an AI-based image-processing algorithm. By demonstrating equivalence with commercially available medical devices, quality-control procedures, and a post-marketing management system — in accordance with more stringent review standards than before — Vieworks has secured its technological capabilities and reliability.
VXvue, developed in-house by Vieworks, is user-centric software that transmits and processes clinical images acquired through an X-ray detector. Equipped with the PureImpact™ algorithm, which enhances the clarity of clinical images, it excels in depicting the details of human soft tissue and skeletal structures.
Recently, Vieworks significantly enhanced its scope of convenience and usability by integrating multiple AI-based image-processing solutions into its internal functions. It offers specialized features for each field, such as Bone-X AI, which enhances the visibility of soft tissue in chest X-ray images, and Noise-X AI, which reduces image noise using a deep learning-based algorithm.
Vieworks’ technological prowess is recognized through FDA approval and European CE certification. Last November, it received FDA approval for its long-type detector, the VIVIX-S 1751S, and in January this year, its mammography X-ray detectors, the VIVIX-M 1824S and VIVIX-M 2430S. In May, it also received European in vitro diagnostic medical device certification, the CE IVDR, for its new slide scanner, the VISQUE DPS (Digital Pathology System) LH510.
Vieworks plans to actively expand its sales network, focusing on certified products. At RSNA 2025, North America’s largest radiology exhibition, to be held later this month, it plans to showcase a number of FDA-approved solutions, including VXvue, which is equipped with a new material X-ray detector and a new image-processing solution.

 
 
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