eCential Robotics Receives FDA 510(k) Clearance for Spine Navigation and Robotic-Assistance Device

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Jul 22, 2024, 07:53 ET

GIÈRES (GRENOBLE), France and NASHVILLE, Tenn., July 22, 2024 /PRNewswire/ -- eCential Robotics is proud to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an innovative Spine Navigation and Robotic-Assistance Device. This device provides a new, advanced solution for planning and instrumenting spinal fusion procedures.

This spine robot was developed by eCential Robotics in the framework of a collaboration with DePuy Synthes (DPS), The Orthopaedics Company of Johnson & Johnson. DPS will leverage its extensive reach and expertise to bring this innovative solution to market.

This milestone achievement highlights eCential Robotics' unique expertise in the field of surgical navigation and robotics, reaffirming its dedication to supporting and advancing the healthcare system.

"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, CEO at eCential Robotics. "We look forward to continuing to deliver cutting-edge solutions that enhance surgical precision and patient outcomes."

eCential Robotics will now continue to focus on developing the commercial activities of its unique Open eCential Platform in the U.S. and partnering with implant manufacturers and tech companies to expand the range of Applications available on the Platform.

About eCential Robotics

eCential Robotics is a French and US-based company, founded by Stéphane Lavallée and part of the Grenoble Haventure network, specializing in surgical robotics. It has developed an open, unified yet modular, and scalable 2D/3D imaging, navigation, and robotic platform aiming to improve bone surgery outcomes. With more than 100 patents and 7 trademarks, eCential Robotics is pursuing a disruptive innovation strategy enabling third parties to develop surgical Apps in its ecosystem. Thanks to multiple partnerships already established with implant manufacturers, tech companies, and research labs, eCential Robotics is positioned as a leader in the fast-growing surgical robotics market and aspires to become the world leader in open robotic platforms.

Please visit www.ecential-robotics.com and follow on LinkedIn (eCential Robotics).

Media contact
Matthieu VILLE
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Investor relations
Benjamin COLAS
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SOURCE eCential Robotics