FDA clears Mazor's combined spinal surgery system
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for Mazor Surgical Technologies' combined spinal surgical system, comprised of the firm's SpineAssist and C-Insight devices. The former is a miniature robotic navigation system to help surgeons accurately place spinal implants, while the latter is an interoperative 3D imaging system. The Israeli firm believes that the combined system will have added value over the two individual devices, as it will enable imaging during surgery without having to move the patient into a separate CT scanning room. Mazor plans to launch the combined product in the US in early 2011, and hopes it will boost sales and support higher prices. Both devices were already individually approved by the FDA.