September 1, 2022
France-based eCential Robotics, which develops 2D/3D imaging, surgical navigation and robotics, has announced FDA 510(k) clearance of its 3D imaging, navigation and robotics guidance system, which secures the penetration of its unified robotic platform in the U.S.
Having recently concluded partnerships with U.S. implant companies, the company said it aims now to access the North American market.
Founded in 2009 by Stephane Lavallee, president and chairman of eCential Robotics, the company aims 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 benefit of patients, the company said it focuses on surgical workflows to make robotic-assisted bone surgery simple enough in clinical routine that it becomes standard. The company said other implant companies can create specific applications for multiple indications in spine, cranial, traumatology, orthopedics, and sports medicine.
Historically, after several years dedicated to the massive development of its unique technology and workflow, eCential Robotics obtained CE marking and successfully launched the commercialization of its first platform in France. Ten units have been sold and installed in Europe and more than 2,000 surgeries performed. To support the penetration of the North American market, an eCential Robotics, Inc. subsidiary was created in December 2020. In Q1 2022, eCential Robotics conducted pre-clinical evaluation tests in the U.S. with neurosurgeons and orthopedic surgeons and hired its first local application engineer. FDA 510(k) clearance of the intra-operative 2D and 3D imaging, navigation and robotic guidance platform, with a first universal application in spine surgery, now secures the plan to access the North American market over the next few years.
“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, and also encourages our ambition to expand our footprint in the United States”, said Laurence Chabanas, eCential Robotics Chief Strategy Officer and CEO of the U.S. division. “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 company said it will exhibit the robotic arm at SMISS 2022 and NASS 2022 congresses in the U.S. For more details on the company, visit the eCential Robotics website here.