eCential Robotics has announced US Food and Drug Administration (FDA) 510(k) clearance of its 3D imaging, navigation and robotics guidance system.
Created in 2009 by company president and chairman, Stéphane Lavallée, eCential Robotics’ goal is to reinforce the safety and accuracy of surgical procedures, while offering simplicity and speed of use.
With the objective of enabling surgeons to operate in a reliable and simple environment for the best benefit of patients, eCential Robotics state that they have concentrated their development on a unique and innovative concept: focusing surgical workflows on the essential to make robotic-assisted bone surgery simple enough in clinical routine that it becomes a standard of care.
The company welcomes implant companies to create specific apps for multiple indications in notably spine, cranial, traumatology, orthopaedics, sports medicine.
eCential Robotics previously obtained CE marking and launched the commercialisation of its first platform in France. Ten units have been sold and installed in Europe and more than two thousand surgeries performed.
Laurence Chabanas, eCential Robotics’ chief strategy officer and USA CEO, said: “The FDA clearance of the eCential Robotics unified platform recognises 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, and also encourages our ambition to expand our footprint in the United States.
“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.”
The unified open platform is a medical device that provides 2D/3D medical imaging and stereotaxic guidance. The system consists of three mobile interconnected units: a mobile C-arm, a mobile viewing workstation, and a mobile collaborative robot. The mobile X-ray system is an imaging robot with five-axis supporting 2D imaging and 3D imaging of anatomical structures and high contrast objects.
The navigation feature with both freehand navigation and robotic guidance, is based on the standard and established technique of navigation systems using 3D optical position tracking technology, including a stereoscopic camera, the computer platform with monitors, a navigation software, a robotic arm and instruments equipped with marker spheres to enable an exact localisation in space.
David Armand, eCential Robotics’ CTO, added: “With still a huge potential for innovation, eCential Robotics simplifies the entire workflow for a seamless surgical experience.”