First-Ever Surgical Platform Unifies Intraoperative 2D/3D Imaging, Navigation and Robotics

The world of healthcare is at a turning point. Patients want risk-free, quality care, physicians need tools that enable them to do their job in a stress-free environment and payers expect organizational and financial optimization. Now, a new system unifies 2D/3D imaging, surgical navigation and robotics into its intimate design, in the same way that vision, brain and the hand work together in the human body.

eCential Robotics (Grenoble, France) has developed the first platform unifying 2D fluoroscopy, 3D imaging and real-time navigation. As the only available solution that is fully unified, it avoids the pitfalls of traditional image-navigation pairing, such as unreliable calibration and registration steps, and streamlines the surgical workflow by automating numerous technical steps. A single user interface for all devices enables to control the imaging, navigation and robotic functionalities from a single input and output graphical display screen. The system is also a fully open solution, meaning that it can be used with any manufacturer's implants. Built around a range of applications ("Apps") currently dedicated to spine surgery, the eCential Robotics platform will in the future expand to multiple bone surgery indications.

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 5-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 localization in space. Cential Robotics obtained CE marking and successfully launched the commercialization of its first platform in France. The latest 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 company’s 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 Mrs. Laurence Chabanas, eCential Robotics Chief Strategy Officer and USA CEO. "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."

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