Regulatory Approval for GYDER Hip Navigation in Australia

Gyder Surgical announced that the Therapeutic Goods Administration (TGA) of Australia granted regulatory approval for the GYDER Hip Navigation System, a non-invasive (Pin-less) and Image-less smart navigation system for total hip replacement surgery using the anterior approach.

GYDER Hip Navigation is a computer-controlled, non-invasive surgical tool to aid navigation during total hip replacement via the anterior approach. It is designed to provide real-time guidance to assist the surgeon in positioning the acetabular cup in the intended orientation during primary or revision hip replacement.

The GYDER system does not use invasive metallic pins utilized by most navigation products in the market. It also does not rely on pre-operative or inter-operative imaging such as computer tomography or x-ray technology. Calibration takes one minute, and registration is quick. It has a small footprint, seamlessly integrates into existing workflow, and is an open platform that provides surgeons flexibility to use their preferred implants. Gyder Surgical plans to commercialize the GYDER Hip Navigation System later this year.

“We are excited to receive the regulatory approval from Australia’s TGA for the GYDER Hip Navigation System. It’s a major milestone and an important step forward in our journey to bring our patented Pin-less and Image-less technology to orthopaedic surgeons in Australia and for improving patient care,” said Sujit Dike, CEO of Gyder Surgical. “We believe that there is a strong appetite for fast, easy-to-use and cost-effective enabling technologies that improve surgical accuracy during orthopaedic surgery.”

Source: Gyder Surgical