France-based eCential Robotics has secured the US Food and Drug Administration (FDA) 510(k) approval for its 2D and 3D imaging, navigation and robotics guidance system.
Through the recently established partnership with US implant companies, the surgical robotics company aims to commercialise its surgical robotics system in North America.
The company called implant companies to create specific applications (Apps) for multiple indications, primarily in the spine, cranial, traumatology, orthopaedics, and sports medicine.
After several years of development, eCential has obtained CE mark approval and commercialised its unique platform in Europe.
The company had installed ten units, which enabled more than two thousand surgical procedures.
eCential Robotics chief strategy officer and US CEO Laurence Chabanas said: “The FDA clearance of the eCential Robotics unified platform recognizes reliability and robustness of our product, confirms the confidence in eCential Robotics’ unique concept of focusing surgical workflows on the essential via a unified, open and multi-app system.
“This 510(k) 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.”
According to eCential, the core design of its surgical platform will combine the functions of intraoperative 2D/3D imaging, navigation, and robotics.
The system contains three mobile interconnected units, a mobile C-arm, a mobile viewing workstation, and a mobile collaborative robot.
It comes with a single user interface, to control the imaging, navigation and robotic functionalities from a single input and output graphical display screen.
In addition, the platform eliminates the unreliable calibration and registration steps, and simplifies the surgical workflow through automation, said eCential.
In December 2020, the company has created a subsidiary in the US, to support its efforts to foray into the North American market.
Earlier this year, it conducted pre-clinical evaluation tests in the US with neurosurgeons and orthopaedic surgeons and hired its first local application engineer.
Currently dedicated to spine surgery, the company aims to expand the platform to multiple bone surgery indications in the future.
eCential Robotics CTO David Armand said: “With still a huge potential for innovation, eCential Robotics simplifies the entire workflow for a seamless surgical experience.”
