FDA Grants 510(k) Clearance To nView s1 Imaging System

A startup called nView Medical has received the FDA’s 510(k) clearance for its nView s1 spinal surgery device with navigation option, AI-enabled image analysis and 3D stitching.

The nView s1 is an imaging system that includes low-dose X-ray imaging and AI-enabled imaging algorithms. It provides multiplanar, fluoroscopic and augmented views derived from fast tomographic reconstructions of the patient during surgery, according to the Salt Lake City, Utah-based company.

The nView s1 can take 3D images on the fly during surgery and surgeons can navigate them immediately, according to nView Medical CEO Cristian Atria.