Mazor Robotics announced FDA approval for the marketing of Emerald, Mazor Robotics’ guided-surgical implant system for spinal fixation procedures.
The Emerald implant successfully met all of the bio-mechanical and regulatory compliance requirements of the FDA. Additionally, the implant has been developed with the support of leading surgeons in both the USA and Europe.
Mazor’s flagship product, SpineAssist, is a surgical robotic system that enables surgeons to conduct spine surgeries in a safe and accurate manner. The system consists of a robot that is mounted on the spine during surgery and a workstation that runs advanced surgical planning software. Emerald implants are used to fixate vertebrae in multiple spine procedures.
“Emerald implants are specially designed to work with our robotic system, creating synergy with the SpineAssist, which facilitates the surgical procedure, benefiting both patients and surgeons.” said Ori Hadomi, CEO of Mazor Robotics.
Mazor expects to begin marketing Emerald in the second half of 2011.