FDA Approves Robotic Spinal Surgery Platform
The FDA has approved a robotic spinal surgery platform, designed to automate several steps of spinal procedures to aid human surgeons.
Developed by eCential Robotics, the platform combines intraoperative 2D and 3D imaging, navigation and robotics to create the surgical assistant. The design features three interconnected mobile units, including a mobile viewing workstation, a mobile C-arm and the mobile collaborative robot itself. All devices are connected to a single user interface, meaning a user can control the imaging, navigation and robotic functions from one place.
The system is also fully open, meaning it can be used with any manufacturer’s implants and can be adapted to specific surgical needs, with users able to create Apps within the software for various uses – such as cranial, orthopedics and sports medicine.
The platform is intended to aid, rather than replace, surgeons and eCential says it aims to “reinforce the safety and accuracy of surgical procedures,” and one day see these robotic assistants become the norm in routine operations.
The FDA approval also marks eCential’s emergence into the U.S. market, with the company previously operating solely across Europe. Since its launch in 2009, eCential has sold 10 units of its platform and seen more than 2,000 surgeries performed, with plans for expansion into the U.S.
“The FDA clearance of the eCential Robotics unified platform recognizes reliability and robustness of our product,” said Laurence Chabanas, CEO of eCential Robotics’ USA branch. “…[It] also encourages our ambition to expand our footprint in the United States. This…is fundamental to our strategy. We are excited about these bold new and disruptive technologies and the role that eCential Robotics can play in reshaping bone surgical procedures and restoring patients’ quality of life.”