ECential Robotics receives FDA clearance for its surgical robotic platform for spine surgery
Friday, September 02, 2022
eCential Robotics, a dynamic MedTech company based in France, has announced the FDA 510(k) clearance of its revolutionary 3D imaging, navigation, and robotics guidance system. This milestone achievement paves the way for the company to introduce its unified robotic platform in the United States, following successful partnerships with implant companies in the country.
With a long-term vision of penetrating the North American market, eCential Robotics was founded in 2009 by Stéphane Lavallée, an esteemed figure serving as the president and chairman. The company's mission centers around enhancing the safety and precision of surgical procedures while prioritizing simplicity and efficiency. By focusing on the essential aspects of surgical workflows, eCential Robotics aims to make robotic-assisted bone surgery a standard of care through a reliable and user-friendly environment. The company invites implant companies to develop specific applications, particularly in spine, cranial, traumatology, orthopedics, and sports medicine.
After years of dedicated technology development and workflow optimization, eCential Robotics received CE marking and successfully launched its first platform in France. The platform has gained traction with ten units sold and installed in Europe, facilitating over two thousand surgeries. In order to expand its presence in the North American market, eCential Robotics established a subsidiary, eCential Robotics, Inc., in December 2020. Subsequently, the company conducted pre-clinical evaluations with neurosurgeons and orthopedic surgeons in the USA during Q1 2022, and hired its first local application engineer. The recent FDA 510(k) clearance for the intra-operative 2D and 3D imaging, navigation, and robotic guidance platform, with an initial focus on spine surgery, solidifies eCential Robotics' plans to enter the North American market in the coming years.
Mrs. Laurence Chabanas, eCential Robotics Chief Strategy Officer and USA CEO, expressed enthusiasm about the FDA clearance and the company's unique concept of streamlining surgical workflows through a unified, open, and multi-app system. She highlighted the clearance's significance in eCential Robotics' expansion strategy and its potential to revolutionize bone surgical procedures and enhance patients' quality of life.
To showcase their innovative technology, the eCential Robotics team will be exhibiting at prominent U.S. conferences, including SMISS 2022 and NASS 2022. Attendees will have the opportunity to witness demonstrations of the company's robotic arm and learn more about its advanced capabilities.
At the core of eCential Robotics' platform is a fully unified solution that integrates intraoperative 2D/3D imaging, navigation, and robotics. Unlike traditional image-navigation combinations, this unified approach eliminates calibration and registration challenges, streamlining the surgical workflow by automating technical steps. The platform offers a single user interface for controlling imaging, navigation, and robotic functionalities, providing a seamless and efficient experience. Furthermore, it is an open solution compatible with implants from any manufacturer. Initially designed for spine surgery, eCential Robotics' platform has the potential to expand to various bone surgery indications through a range of applications ("Apps").
The unified open platform comprises three interconnected mobile units: a mobile C-arm, a mobile viewing workstation, and a mobile collaborative robot. The mobile X-ray system serves as an imaging robot, enabling 2D and 3D imaging of anatomical structures and high-contrast objects with its 5-axis capabilities. The navigation feature combines freehand navigation and robotic guidance using 3D optical position tracking technology, including a stereoscopic camera, a computer platform with monitors, navigation software, a robotic arm, and instruments equipped with marker spheres for precise spatial localization.