South Korean medical robotics company CUREXO has announced that its spinal surgery robot, CUVIS-spine, has now acquired US Food and Drug Administration (FDA) licensing.
This is the third license acquired for CUVIS-spine as the company looks to expand its global reach and follows licenses from Korea in 2019 and Europe (CE) in 2020.
CUVIS-spine is a next-generation spinal surgery robot that guides the insertion of a pedicle screw according to the surgery plan. It uses a high precision robot arm, wireless one-step, navigation based on a real-time OTS sensor to provide precise, safe and faster surgery compared to traditional manual surgery. It also minimises the filming and reduces the radiation exposure of both patients and medical staff, say CUREXO in a recent press release.
The firm adds that both 2D filming (C-arm) and 3D filming (O-arm) are applicable with the solution which provides “great expandability”. It allows multiple steps of traditional manual surgery to be performed with one surgery tool and “reduces surgery duration greatly”. It allows for minimally invasive surgery which means that the patient’s recovery time will be quicker compared to manual surgery.
Jae-Joon Lee, CEO of CUREXO, said: “The spinal surgery robot, CUVIS-spine, that we have developed and manufactured with our technology has acquired FDA licensing. This is the third license that we have acquired, followed by Korea and Europe, and now we can sell our solution in all countries including the US which is the biggest medical market.”