FDA 510(k) for nView s1 Surgical Navigation

By Julie A. Vetalice

FDA 510(k) for nView s1 Surgical Navigation

nView medical announces FDA 510(k) clearance of the nView s1 with navigation option.

nView s1 is an imaging system that integrates the latest developments in low-dose X-ray imaging and AI-enabled imaging algorithms to provide multiplanar, fluoroscopic and augmented views derived from fast tomographic reconstructions of the patient during surgery. With the addition of navigation these images can now be used for surgical guidance, providing greater utility for surgeons during spine procedures.

nView medical CEO, Cristian Atria, commented: “What makes nView’s approach a breakthrough is that with insta-3D™, 3D images can be taken on the fly during surgery, providing a true representation of the anatomy. These images can be navigated immediately, we call this unique approach true-map navigation™. We believe that the nView s1 with integrated navigation is the most efficient solution in terms of minimizing surgical time, minimizing the footprint in the OR, and minimizing radiation to the patient. This is a major milestone for nView as we augment our image creation offering with image utilization technologies. With this 510(k) we also cleared AI-enabled image analysis and advanced imaging modes such as 3D stitching.”

Source: nView medical

Product Labels: Surgical Navigation

Tags: 510(k) Clearance, Regulatory