FDA clears nView medical’s first imaging system - nView s1
nView today announced the FDA clearance of nView s1, the company’s first imaging system, bringing breakthrough imaging technology to surgery.
Salt Lake City, UT, Saturday July 13th 2019. nView medical Inc. (nView) today announced the U.S. Food and Drug Administration (FDA) clearance of nView s1, the company’s first imaging system, bringing breakthrough imaging technology to surgery.
nView’s mission is to make surgery safer, faster, and consistently accurate by creating instant 3D information throughout the surgical procedure. nView s1 integrates the latest developments in low-dose x-ray imaging with intelligent imaging algorithms to provide fluoroscopic and multi-planar views derived from tomographic reconstructions. These views can be used by surgeons to accurately assess the anatomy and placement of implants during spinal and orthopedic procedures.
“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” said Cristian Atria, founder and CEO at nView medical.
Lisa Last, COO, commented: “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. The 510(k) clearance will allow us to expand our work with research partners in pilot sites”.
nView medical, based in Salt Lake City, UT, is an early stage start-up whose mission is to make surgery safer, faster, and consistently accurate. nView develops imaging systems, bringing breakthrough AI solutions for image creation, image processing, and image visualization to surgery. nView medical backers include the National Science Foundation (NSF), the National Institutes of Health (NIH), the State Of Utah, the National Consortium for Pediatric Device Innovation, MedtechInnovator, Dr. Kevin Foley, MD, and Fusion Fund (Palo Alto, CA).
FDA 510(k) Premarket Notification: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190064