French robotic spine surgery tech company eCential Robotics announced today that it has received FDA clearance for its 3D imaging, navigation and robotics guidance system.
With the help of recent partnerships with U.S. implant companies, Gières, France–based eCential Robotics plans to start selling its surgical robotics system in North America. The company has already sold 10 systems in Europe, with more than 2,000 surgeries.
“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, the company’s chief strategy officer and U.S. CEO.
Surgical robotics is a hot space, with a host of companies competing. Medtech giant Medtronic is presently the dominant player in the robotic spine surgery space with its Mazor robots. Medtronic reported record sales of its StealthStation navigation, O-arm, and Mazor systems in its most recent quarter. [Here’s a roundup of 16 surgical robotics companies you need to know.]
Officials at eCential Robotics think they have an edge because their system unifies intraoperative 2D/3D imaging, navigation, and robotics. A unified system avoids unreliable calibration and registration steps and other pitfalls involved in traditional image-navigation pairing, according to the company. It also streamlines the surgical workflow and automates technical steps.
The eCential Robotic system has a single user interface for all devices. It’s also possible to use the system with any manufacturer’s implants.
Currently running on spine surgery apps, the company plans to expand system uses to other bone surgery indications in the future.
Said the company’s CTO David Armand: “With still a huge potential for innovation, eCential Robotics simplifies the entire workflow for a seamless surgical experience.”