SpineGuard obtains regulatory clearance to sell PediGuard in China


SpineGuard has received regulatory clearance to market its Classic PediGuard products in China, the second largest spine market in the world.

“This regulatory clearance is the result of a diligent collaborative process with General Care International,” said Pierre Jérôme, co-founder and chief executive officer of SpineGuard. “It is a major milestone for SpineGuard and further validates the value of our Dynamic Surgical Guidance-based PediGuard device for making spine surgery safer.”

The Chinese spine market has become the second-largest market in the world, after the USA, and is projected to be worth over US$1bn by 2019 according to IData Research, driven by an ageing population, increasing disease, improving treatment rate and growing affordability. “The number of spine fusions is growing rapidly across China, and I believe there is a strong need for a simple smart device like PediGuard consistently ensuring safe and accurate placement of pedicle screws,” added Yong Qiu, chief spinal surgeon at the Nanjing University Hospital, China.