eCential Robotics announced today that it received FDA 510(k) clearance for its spine navigation and robotic-assistance device.
Gières, France-based eCential Robotics designed the device as a new, advanced solution for planning and instrumenting spinal fusion procedures. It developed the spine robot in the framework of a collaboration with Johnson & Johnson’s DePuy Synthes unit.
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According to a news release, in the collaboration, DePuy offers its reach and expertise to help bring the solution to market.
eCential Robotics already has an FDA-cleared robot available, with its Surgivisio system winning an FDA nod in 2022. The company’s open, unified, modular and scalable 2D/3D imaging, navigation, and robotic platform aims to improve bone surgery outcomes.
The company said it plans to focus on developing the commercial activities for its Open eCential platform in the U.S. It also wants to partner with implant manufacturers and tech companies. This effort aims to expand the range of applications available for the platform.
“This additional FDA clearance is a testament to our relentless pursuit of innovation and excellence in the field of surgical robotics and navigation,” said Clément Vidal, the new CEO at eCential Robotics. “We look forward to continuing to deliver cutting-edge solutions that enhance surgical precision and patient outcomes.”
Vidal took over the corner office at eCential just last week. His focus centers around enhancing the company’s product portfolio roadmap, develop its commercial activities in the U.S. and partnering internationally with implant manufacturers, tech companies and research labs.
