US-based nView medical has secured approval from the US Food and Drug Administration (FDA) for its nView s1 imaging system.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
The nView s1 system incorporates the latest developments in low-dose x-ray imaging with intelligent imaging algorithms to offer fluoroscopic and multi-planar views derived from tomographic reconstructions.
Surgeons can use these views to precisely evaluate the anatomy and placement of implants during spinal and orthopaedic procedures.
nView medical founder and CEO said: “nView s1 is an imaging platform that provides invaluable information to surgeons throughout the procedure.
“The technology can be used intraoperatively to visualize the surgery and at the end of the procedure to confirm the quality of the surgery. The future of surgery will be enabled by automation and quantification. nView s1 is our first step in that direction.”
The nView s1system features insta-3D technology, which offers 3D images in two seconds without interrupting the surgical workflow.
Its quantum-dose technology has been designed for the creation of 3D images with a fraction of the radiation dose. The virtual-fluoroscopy derives fluoroscopic views from 3D images to enable simultaneous visualization of AP, lateral and even axial views from a single system position.
nView medical COO Lisa Last said: “nView s1 has been cleared as a fluoroscopic and tomographic imaging system for adult and pediatric populations. In pediatrics, our low-dose operation brings a unique opportunity to increase precision via 3D imaging while minimizing radiation exposure.”
Based in Salt Lake City of Utah, nView medical is an early stage start-up working to improve safety, speed and accuracy of surgery by creating instant 3D information across the surgical procedure.
The company is involved in the development of advanced imaging systems, as well as to provide AI solutions for image creation, image processing and image visualisation for surgery.
nView medical is supported by the National Science Foundation (NSF), the National Institutes of Health (NIH), the State Of Utah, the National Consortium for Paediatric Device Innovation, Fusion Fund and medtech innovator Dr Kevin Foley.