eCential Wins FDA Nod for Spine Navigation Robot Developed with DePuy Synthes

eCential Robotics has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its spine navigation and robotic-assistance device.

The new, advanced solution to plan and instrument spinal fusion procedures was developed via a collaboration with Johnson & Johnson MedTech’s DePuy Synthes business. eCential said DePuy Synthes will leverage its reach and expertise to help bring the solution to the market.

eCential has an FDA-cleared robot available, which earned the agency’s 510(k) clearance in 2022. The company’s open, modular, and scalable 2D/3D imaging, real-time navigation, and robotic system was designed to improve the outcomes of bone surgery.

“This additional FDA clearance is a testament to our relentless pursuit of innovation and excellence in the field of surgical robotics and navigation,” said eCential CEO Clément Vidal, who took office last week. “We look forward to continuing to deliver cutting-edge solutions that enhance surgical precision and patient outcomes.”

The company also said it will continue to develop the Open eCential Platform’s commercial activities in the U.S. eCential also plans to partner with implant manufacturers and technology companies to expand the range of applications available on its platform. The company already has multiple partnerships already established with implant manufacturers, tech companies, and research labs.