[Digital Radiography Acquisition Software, 'VXvue']

 
Vieworks, a global provider of medical and industrial imaging solutions, said its digital image acquisition and processing software ‘VXvue’ has received U.S. FDA 510(k) clearance. The clearance enables the company to offer a fully integrated medical imaging solutiom-combining detectors and proprietary software-in the North American market.
 
This marks Vieworks’ first FDA clearance for software featuring AI-driven image enhancement. The company met strengthened regulatory requirements, demonstrating substantial equivalence, quality management, and post-market surveillance procedure.
 
VXvue provides acquisition, transmission and image processing tailored to Vieworks’ X-ray detectors. Its ‘PureImpact™’ algorithm sharpens clinical images and enhances visualization of soft tissue and bone. The software also includes presets for humans, veterinary, and vehicle-based workflows.
 
Recent updates incorporate multiple AI-based tools, including ‘Bone-X AI’ for improved soft-tissue visibility in chest radiographs and ‘Noise-X AI’, a deep-learning based noise-reduction algorithm.
 
Vieworks has expanded its regulatory footprint across the U.S. and Europe. The company gained FDA clearance for three X-ray detectors over the past year, and its VISQUE DPS digital pathology scanner recently earned CE-IVDR certification. 
 
“FDA clearance confirms that Vieworks is not only strong in hardware but also advancing in software innovation,” a company spokesperson said. “We will continue developing solutions that support low-dose imaging, clinical workflow efficiency and evolving global regulatory standards.”



*New Medical Imaging (NMI) is the subsidiary of Vieworks, which is the top 3 Flat Panel Detector manufacturer in the global rankings. 

If you want to know more Vieworks' X-ray Solution, welcome to contact us👉 sales@newmedical.com.tw