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Spineart and eCential Robotics Secure FDA Clearance for Robotic Spine App

The U.S. Food and Drug Administration has granted 510(k) clearance for Spineart’s PERLA® TL application to operate within the eCential® Op.n® navigation and robotic-assisted platform, marking a strategic expansion of the companies' collaborative efforts to integrate implant technology with active robotics for complex spine surgery workflows.

Bio & NewsAugust 26, 2026591 reads0

This regulatory approval enables surgeons to utilize the PERLA® app across both open and minimally invasive spine procedures. By merging Spineart’s pedicle screw systems with eCential Robotics’ navigation interface, the platform aims to enhance implant placement accuracy and procedural consistency. The integration is designed to streamline the surgical environment, allowing for real-time robotic support that adapts to the specific needs of the patient.

Laurent Nodé-Langlois, Chief Technology Officer at Spineart, described the milestone as a move toward a more collaborative robotic platform, emphasizing simplicity and precision. Lisa Jacobs, President of North America at eCential Robotics, highlighted the synergy between the two firms, noting that the clearance validates their shared vision for an open robotic architecture. The PERLA® application is now available for demonstration at the Spineart Innovation Center in Dallas, Texas, as the companies look to capture a larger share of the growing market for navigation-supported spinal interventions.

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